Clinical trial • Phase III • Gastroenterology

LANIFIBRANOR for Non-alcoholic steatohepatitis (NASH)

Phase III trial of LANIFIBRANOR for Non-alcoholic steatohepatitis (NASH).

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Non-alcoholic steatohepatitis (NASH)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
22-08-2024

Trial design

Randomised, placebo (pl1) matching tablet (composition: lactose monohydrate, microcrystalline cellulose, pre gelatinized starch, magnesium stearate, opadry™ ii 85f18422, purified water); no active comparator dose or schedule specified.-controlled Phase III trial in Hungary, Belgium, Italy and others.

Randomised
Yes
Comparator
Placebo (PL1) matching tablet (composition: lactose monohydrate, microcrystalline cellulose, pre gelatinized starch, magnesium stearate, opadry™ II 85F18422, purified water); no active comparator dose or schedule specified.
Target Sample Size
1114
Trial Duration For Participant
504

Eligibility

Recruits 1114 The dataset flags 'isVulnerablePopulationSelected' = true, but the available public CTIS documents do not provide detailed description of specific vulnerable groups or assent handling. Consent is described for adults (≥18 years) only; no explicit assent/parental consent procedures or additional vulnerable-population consent processes are present in the provided files..

Pregnancy Exclusion
Negative serum pregnancy test at study Screening for females of childbearing potential confirmed by central laboratory.
Vulnerable Population
The dataset flags 'isVulnerablePopulationSelected' = true, but the available public CTIS documents do not provide detailed description of specific vulnerable groups or assent handling. Consent is described for adults (≥18 years) only; no explicit assent/parental consent procedures or additional vulnerable-population consent processes are present in the provided files.

Inclusion criteria

  • {"criterion_text":"- 1. Able to understand the nature of the study, willing and able to comply with the study procedures and restrictions, and able to provide signed, dated and written informed consent obtained before any study-related activities, sampling or analysis."}
  • {"criterion_text":"- 2. The patient will be willing to continue on the study in case of moving or relocation during the first 72 weeks of the study."}
  • {"criterion_text":"- 3. Male or female, aged ≥18 years at the time of signing informed consent"}
  • {"criterion_text":"- 4.If biopsy is performed before Screening, i.e. if a historical biopsy is available, a histological diagnosis of NASH with liver fibrosis must be made no more than 7 months before randomisation"}
  • {"criterion_text":"- 5. Main cohort: Upon central biopsy reading process: diagnosis of NASH according to the Steatosis-Activity-Fibrosis (SAF): a.Steatosis score ≥1 b.Activity score: A3 or A4 c.Fibrosis score: F2 or F3 Exploratory cohort: Patients who, upon central biopsy reading process, do not meet the eligibility criteria described above but fulfil the following criteria: diagnosis of NASH according to the Steatosis-Activity- Fibrosis (SAF): a) Steatosis score ≥1 b) Activity score ≥2 with SAF-Inflammation score ≥1 and SAF-Ballooning score ≥1 c) Fibrosis score: F1 to F3"}
  • {"criterion_text":"- 6. Model for End-Stage Liver Disease (MELD) score ≤12 (unless patient is on anticoagulants)"}
  • {"criterion_text":"- 7. For patients receiving the concomitant medications listed below: no qualitative change in dose are allowed (changes having minimal clinical impact like temporary cessation/change between class of drugs are allowed), for the specified period prior to the qualifying liver biopsy and dose must remain stable from the time of the liver biopsy until the Baseline visit (Visit 0): a. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists including combinations) or sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors): for at least 3 months b. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months c. Statins for at least 3 months d. Anti-obesity treatments for at least 6 months"}
  • {"criterion_text":"- 8. For patients receiving concomitant medications not covered by criterion #7 and that may impact safety or efficacy evaluation (antidiabetic treatments other than GLP1 (or combinations) receptor agonists and SGLT2 inhibitors, antihypertensives, antidepressants, cardiovascular, antihyperlipidemic) no qualitative change in dose are allowed for at least 3 months prior to the Baseline visit (Visit 0) or for at least 8 weeks prior to Screening visit for herbal/dietary supplement with potential liver toxicity or those with unknown composition and dose must remain stable until the Baseline visit (Visit 0)"}
  • {"criterion_text":"- 9. For overweight/obese patient, history of at least 1 unsuccessful attempt to reduce body weight by diet and/or exercise within the past 6 years"}
  • {"criterion_text":"- 10. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods)"}
  • {"criterion_text":"- 12. Patient agrees to follow recommendations with lifestyle modifications, which will be monitored throughout the whole study period."}
  • {"criterion_text":"- 13. Negative serum pregnancy test at study Screening for females of childbearing potential confirmed by central laboratory."}

Exclusion criteria

  • {"criterion_text":"- Liver-related: 1.Documented causes of chronic liver disease other than NASH including, but not restricted to: a.Viral hepatitis b.Drug-induced liver disease c.Alcoholic liver disease d.Autoimmune hepatitis (See Exclusion criteria 44 for more information) e.Wilson's disease f.Haemochromatosis g.Primary biliary cholangitis h.Primary sclerosing cholangitis i.Alpha-1-antitrypsin deficiency j.Chronic portal vein thrombosis or splenic vein thrombosis"}
  • {"criterion_text":"- 2.Histologically documented liver cirrhosis in the most recent historical biopsy (fibrosis stage F4) or suspicion at screening of cirrhosis based on clinic biochemical and imaging criteria"}
  • {"criterion_text":"- 3.History or current diagnosis of hepatocellular carcinoma (HCC)"}
  • {"criterion_text":"- 4.History of or planned liver transplant"}
  • {"criterion_text":"- 5.Inability or unwillingness to undergo a liver biopsy at Screening (if a suitable historical biopsy is unavailable for central review) and at Week 72"}
  • {"criterion_text":"- 6.Positive human immunodeficiency virus (HIV) serology"}
  • {"criterion_text":"- 7.ALT or AST >5 × ULN"}
  • {"criterion_text":"- 8.Abnormal synthetic liver function of any of the following: a.Albumin below the lower limit of the normal range b.International normalised ratio (INR) ≥1.3 (unless patient is on anticoagulants) c.Total bilirubin level ≥1.5 mg/dL (25.6 μmol/L) Patients with a history of Gilbert's syndrome can be enrolled if the direct bilirubin is ≤0.45 mg/dL (7.7 μmol/L)"}
  • {"criterion_text":"- 9.Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males"}
  • {"criterion_text":"- 10.Leucocytes count < LLN. A lower count is acceptable in patients with benign ethnic neutropenia, if considered to be clinical insignificant by the investigator."}
  • {"criterion_text":"- 11.Platelet count <140,000/μL."}
  • {"criterion_text":"- 12.Alkaline phosphatase (ALP) >2 × ULN"}
  • {"criterion_text":"- 13.Patient currently receiving any approved treatment for NASH"}
  • {"criterion_text":"- 14.Current or recent history (<5 years) of significant alcohol consumption, which is typically defined as higher than 30 g pure alcohol per day for men and as higher than 20 g pure alcohol per day for women"}
  • {"criterion_text":"- 15.Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy"}
  • {"criterion_text":"- Glycaemia related: 16.HbA1c >9% at Screening"}
  • {"criterion_text":"- 17.Diabetes mellitus other than type 2"}
  • {"criterion_text":"- 18.-43. Refer to protocol for full list"}
  • {"criterion_text":"- Autoimmune related: 44.Any patient with a predisposition to autoimmune liver disease, incl: a)Signs on liver biopsy suggestive of autoimmune liver disease b)Family history of autoimmune liver disease in a first degree relative c)Autoimmune thyroid disease"}
  • {"criterion_text":"- 1.Diagnosis of autoimmune thyroid disease"}
  • {"criterion_text":"- 2.Thyroid replacement hormone unless documented for reason of primary thyroid insufficiency"}
  • {"criterion_text":"- 3.Positive autoimmune antibodies associated with abnormal thyroid function testing (TSH, T4 or free T3) i.Anti-thyroid peroxidase antibody (TPO) or ii.Anti-TSH receptor antibodies (TRAb)"}
  • {"criterion_text":"- d)History of or positive testing at screening for: 1.Anti-nuclear antibodies (ANA) at a dilution of 1:320 or greater 2.Anti-mitochondrial antibodies (AMA) 3.Anti-smooth muscle antibodies (ASMA) at a dilution of 1:320 or greater 4.Anti-liver kidney microsomal type 1 antibodies (LKM1) 5.Anti-liver cytosol type 1 antibody (LC1)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score ≥1 stage decrease compared to Baseline.","definition_or_measurement_approach":"Defined by NASH CRN scores: ballooning = 0 and inflammation = 0–1, and a decrease in fibrosis score by ≥1 stage vs Baseline; assessed by central biopsy reading."}

Secondary endpoints

  • {"endpoint_text":"- Resolution of NASH and no worsening of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0, inflammation of 0 to 1, and no increase in fibrosis score when compared to Baseline.","definition_or_measurement_approach":"Defined by NASH CRN scores: ballooning = 0, inflammation = 0–1, and no increase in fibrosis score vs Baseline; assessed by central biopsy reading."}
  • {"endpoint_text":"- Improvement of fibrosis and no worsening of NASH at Week 72, defined by a decrease in NASH CRN fibrosis score ≥1 stage from Baseline and no increase in scores for ballooning, inflammation, or steatosis.","definition_or_measurement_approach":"Defined as reduction in NASH CRN fibrosis score by ≥1 stage vs Baseline with no increase in ballooning, inflammation or steatosis scores; assessed by central biopsy reading."}

Recruitment

Registry Or Advocacy Recruitment
True, Amsterdam UMC Stichting (listed as a patient organisation/association at a Netherlands site) and country-specific 'Advocacy Outreach Text' materials are referenced in recruitment documents.
Planned Sample Size
1114
Recruitment Window Months
58
Consent Approach
Written, signed and dated informed consent is required prior to any study-related activities. Participants are adults (≥18) and provide their own consent. Multiple country-specific ICFs and subject information sheets are provided (languages available across documents include English, French, Dutch, Hungarian, Italian, Spanish, Polish, German, Portuguese, Czech, Bulgarian). Separate/addendum ICFs or information sheets exist for pregnancy data collection, genetic testing, ECG and PK procedures, DEXA scans and other specific procedures.

Methods

  • Patient brochure / patient-facing materials (country-specific patient brochures available)
  • Patient letter (site-to-patient invitation letters)
  • Dear colleague / colleague letter directed to clinicians to aid site referral
  • Print advertisements (5x7 color and BW) for patient outreach
  • Study site posters and site recruitment materials
  • Advocacy outreach text (materials prepared for patient advocacy outreach)
  • Site-specific recruitment procedures (K1 documents) to guide local recruitment activities

Geography

Total Number Of Sites
99
Total Number Of Participants
236

Hungary

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
26-08-2024
Processing Time Days
56
Number Of Sites
4
Number Of Participants
4

Sites

Site Name
University Of Debrecen
Department Name
Infektológiai Klinika
Principal Investigator Name
István Zsolt Várkonyi
Principal Investigator Email
varkonyi.istvan@kenezy.unideb.hu
Contact Person Name
István Zsolt Várkonyi
Site Name
High Tech Medical Kft.
Principal Investigator Name
Tamás Gergely Nyéky
Principal Investigator Email
ceo@hightechmedicalkft.hu
Contact Person Name
Tamás Gergely Nyéky
Contact Person Email
ceo@hightechmedicalkft.hu
Site Name
MIND Klinika Kft.
Principal Investigator Name
Tibor Gyökeres
Principal Investigator Email
gyokereshonvedstudy@gmail.com
Contact Person Name
Tibor Gyökeres
Contact Person Email
gyokereshonvedstudy@gmail.com
Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
Szent László Telephely
Principal Investigator Name
Mihály Makara
Principal Investigator Email
michael@makara.md
Contact Person Name
Mihály Makara
Contact Person Email
michael@makara.md

Belgium

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
23-08-2024
Processing Time Days
53
Number Of Sites
11
Number Of Participants
27

Sites

Site Name
Az Maria Middelares Gent
Department Name
Digestive Centre
Principal Investigator Name
Christophe Van Steenkiste
Principal Investigator Email
christophe.vansteenkiste@azmmsj.be
Contact Person Name
Christophe Van Steenkiste
Site Name
Universitair Ziekenhuis Gent
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Anja Geerts
Principal Investigator Email
anja.geerts@uzgent.be
Contact Person Name
Anja Geerts
Contact Person Email
anja.geerts@uzgent.be
Site Name
Algemeen Ziekenhuis Delta
Department Name
Gastroenterology
Principal Investigator Name
Charlotte De Vloo
Principal Investigator Email
Charlotte.devloo@azdelta.be
Contact Person Name
Charlotte De Vloo
Contact Person Email
Charlotte.devloo@azdelta.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Gastro-entérologie, Hépatologie et Oncologie digestive
Principal Investigator Name
Jean Delwaide
Principal Investigator Email
jean.delwaide@chuliege.be
Contact Person Name
Jean Delwaide
Contact Person Email
jean.delwaide@chuliege.be
Site Name
Ziekenhuis Oost Limburg
Department Name
Gastroenterology
Principal Investigator Name
Mathieu Struyve
Principal Investigator Email
Mathieu.struyve@zol.be
Contact Person Name
Mathieu Struyve
Contact Person Email
Mathieu.struyve@zol.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Gastroenterology
Principal Investigator Name
Nicolas Lanthier
Principal Investigator Email
nicolas.lanthier@uclouvain.be
Contact Person Name
Nicolas Lanthier
Contact Person Email
nicolas.lanthier@uclouvain.be
Site Name
Vitaz
Department Name
Gastrogroep
Principal Investigator Name
Jeoffrey Schouten
Principal Investigator Email
jeoffrey.schouten@vitaz.be
Contact Person Name
Jeoffrey Schouten
Contact Person Email
jeoffrey.schouten@vitaz.be
Site Name
Az St-Jan Brugge-Oostende A.V.
Department Name
Gastroenterology
Principal Investigator Name
Christophe Schoonjans
Principal Investigator Email
christophe.schoonjans@azsintjan.be
Contact Person Name
Christophe Schoonjans
Site Name
Hopital Erasme
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Christophe Moreno
Principal Investigator Email
christophe.moreno@erasme.ulb.ac.be
Contact Person Name
Christophe Moreno
Site Name
Antwerp University Hospital
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Sven Francque
Principal Investigator Email
sven.francque@uza.be
Contact Person Name
Sven Francque
Contact Person Email
sven.francque@uza.be
Site Name
UZ Leuven
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Jef Verbeek
Principal Investigator Email
Jef.verbeek@uzleuven.be
Contact Person Name
Jef Verbeek
Contact Person Email
Jef.verbeek@uzleuven.be

Italy

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
27-08-2024
Processing Time Days
57
Number Of Sites
10
Number Of Participants
15

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Scienze Mediche e Chirurgiche Addominali ed Endocrino Metaboliche
Principal Investigator Name
Luca Miele
Principal Investigator Email
luca.miele@policlinicogemelli.it
Contact Person Name
Luca Miele
Site Name
Casa Sollievo Della Sofferenza
Department Name
Epatologia
Principal Investigator Name
Alessandra Mangia
Principal Investigator Email
a.mangia@operapadrepio.it
Contact Person Name
Alessandra Mangia
Contact Person Email
a.mangia@operapadrepio.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Dipartimento dei servizi
Principal Investigator Name
Luca Valenti
Principal Investigator Email
luca.valenti@unimi.it
Contact Person Name
Luca Valenti
Contact Person Email
luca.valenti@unimi.it
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
U.O.C. Gastroenterologia ed Epatologia
Principal Investigator Name
Filomena Morisco
Principal Investigator Email
filomena.morisco@unina.it
Contact Person Name
Filomena Morisco
Contact Person Email
filomena.morisco@unina.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Medicina interna 1
Principal Investigator Name
Cristina Rigamonti
Principal Investigator Email
cristina.rigamonti@uniupo.it
Contact Person Name
Cristina Rigamonti
Contact Person Email
cristina.rigamonti@uniupo.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico (second site)
Department Name
Gastroenterologia ed Epatologia
Principal Investigator Name
Pietro Lampertico
Principal Investigator Email
pietro.lampertico@unimi.it
Contact Person Name
Pietro Lampertico
Contact Person Email
pietro.lampertico@unimi.it
Site Name
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Department Name
Gastroenterologia
Principal Investigator Name
Salvatore Petta
Principal Investigator Email
salvatore.petta@unipa.it
Contact Person Name
Salvatore Petta
Contact Person Email
salvatore.petta@unipa.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
S.C. Gastroenterologia U
Principal Investigator Name
Elisabetta Bugianesi
Principal Investigator Email
elisabetta.bugianesi@unito.it
Contact Person Name
Elisabetta Bugianesi
Contact Person Email
elisabetta.bugianesi@unito.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name
Gastroenterologia
Principal Investigator Name
Francesco Azzaroli
Principal Investigator Email
francesco.azzaroli@unibo.it
Contact Person Name
Francesco Azzaroli
Contact Person Email
francesco.azzaroli@unibo.it
Site Name
Azienda Ospedaliero Universitario Policlinico Umberto I
Department Name
Clinica medica
Principal Investigator Name
Francesco Baratta
Principal Investigator Email
francesco.baratta@uniroma1.it
Contact Person Name
Francesco Baratta
Contact Person Email
francesco.baratta@uniroma1.it

Czechia

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
27-08-2024
Processing Time Days
57
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Synexus Czech s.r.o.
Principal Investigator Name
Václav Šmíd
Principal Investigator Email
venca.smid@gmail.com
Contact Person Name
Václav Šmíd
Contact Person Email
venca.smid@gmail.com

Bulgaria

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
23-08-2024
Processing Time Days
53
Number Of Sites
6
Number Of Participants
12

Sites

Site Name
Tokuda Hospital
Department Name
Gastroenterology Department
Principal Investigator Name
Rozalina Balabanska
Principal Investigator Email
rozabalabanska@abv.bg
Contact Person Name
Rozalina Balabanska
Contact Person Email
rozabalabanska@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department Name
Gastroenterology Department
Principal Investigator Name
Kamen Danov
Principal Investigator Email
dr.danov@abv.bg
Contact Person Name
Kamen Danov
Contact Person Email
dr.danov@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
Gastroenterology
Principal Investigator Name
Deian Jelev
Principal Investigator Email
detjelev@gmail.com
Contact Person Name
Deian Jelev
Contact Person Email
detjelev@gmail.com
Site Name
Diagnostic-Consultative Center Alexandrovska EOOD
Principal Investigator Name
Diana Stefanova- Petrova
Principal Investigator Email
d.petrova.stefanova@gmail.com
Contact Person Name
Diana Stefanova- Petrova
Contact Person Email
d.petrova.stefanova@gmail.com
Site Name
Medical Center Medica Plus Ltd.
Principal Investigator Name
Ilko Kosturkov
Principal Investigator Email
ikosturkov@mcmedicaplus.com
Contact Person Name
Ilko Kosturkov
Contact Person Email
ikosturkov@mcmedicaplus.com
Site Name
Diagnostic Consultation Center XX-Sofia EOOD
Principal Investigator Name
Dimitr Dimitrov
Principal Investigator Email
dr.dimitar.dimitrov.md@gmail.com
Contact Person Name
Dimitr Dimitrov

Netherlands

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
23-08-2024
Processing Time Days
53
Number Of Sites
7
Number Of Participants
13

Sites

Site Name
Radboud universitair medisch centrum / RADBOUDUMC
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Joost Drenth
Principal Investigator Email
joost.drenth@radboudumc.nl
Contact Person Name
Joost Drenth
Contact Person Email
joost.drenth@radboudumc.nl
Site Name
Amsterdam UMC Stichting
Department Name
Vascular Medicine, Internal Medicine in collab. with Hepatology
Principal Investigator Name
Adriaan Holleboom
Principal Investigator Email
a.g.holleboom@amsterdamumc.nl
Contact Person Name
Adriaan Holleboom
Contact Person Email
a.g.holleboom@amsterdamumc.nl
Site Name
Sint Franciscus Vlietland Groep Stichting
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Robert Roomer
Principal Investigator Email
r.roomer@franciscus.nl
Contact Person Name
Robert Roomer
Contact Person Email
r.roomer@franciscus.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Karel van Erpecum
Principal Investigator Email
k.j.vanerpecum@umcutrecht.nl
Contact Person Name
Karel van Erpecum
Contact Person Email
k.j.vanerpecum@umcutrecht.nl
Site Name
St. Elisabeth Hospital Tilburg
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Robert Laheij
Principal Investigator Email
r.laheij@etz.nl
Contact Person Name
Robert Laheij
Contact Person Email
r.laheij@etz.nl
Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Willem Brouwer
Principal Investigator Email
w.p.brouwer@erasmusmc.nl
Contact Person Name
Willem Brouwer
Contact Person Email
w.p.brouwer@erasmusmc.nl
Site Name
Bernhoven B.V.
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Ingrid Gisbertz
Principal Investigator Email
i.gisbertz@bernhoven.nl
Contact Person Name
Ingrid Gisbertz
Contact Person Email
i.gisbertz@bernhoven.nl

Spain

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
26-08-2024
Processing Time Days
56
Number Of Sites
16
Number Of Participants
33

Sites

Site Name
Parc Tauli Hospital Universitari
Department Name
Digestive Department
Principal Investigator Name
Meritxell Casas Rodrigo
Principal Investigator Email
mcasasr@tauli.cat
Contact Person Name
Meritxell Casas Rodrigo
Contact Person Email
mcasasr@tauli.cat
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hepatology Department
Principal Investigator Name
Manuel Romero Gómez
Principal Investigator Email
manuel.romero.sspa@juntadeandalucia.es
Contact Person Name
Manuel Romero Gómez
Site Name
Clinica Universidad De Navarra
Department Name
Hepatology Department
Principal Investigator Name
Delia D'Avola
Principal Investigator Email
ddavola@unav.es
Contact Person Name
Delia D'Avola
Contact Person Email
ddavola@unav.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hepatology Department
Principal Investigator Name
Juan Manuel Pericàs Pulido
Principal Investigator Email
juanmanuel.pericas@vallhebron.cat
Contact Person Name
Juan Manuel Pericàs Pulido
Site Name
Hospital Germans Trias I Pujol
Department Name
Digestive Department
Principal Investigator Name
Rosa María Morillas Cunill
Principal Investigator Email
rmorillas.germanstrias@gencat.cat
Contact Person Name
Rosa María Morillas Cunill
Site Name
Complexo Hospitalario Universitario De Pontevedra
Department Name
Hepatology and Gastroenterology Department
Principal Investigator Name
Juan Turnes Vázquez
Principal Investigator Email
juan.turnes.vazquez@sergas.es
Contact Person Name
Juan Turnes Vázquez
Contact Person Email
juan.turnes.vazquez@sergas.es
Site Name
University Hospital Son Espases
Department Name
Digestive Department
Principal Investigator Name
María Lucía Bonet Vidal
Principal Investigator Email
lbonet@hsd.es
Contact Person Name
María Lucía Bonet Vidal
Contact Person Email
lbonet@hsd.es
Site Name
Consorcio Hospital General Universitario De Valencia
Department Name
Hepatology Unit
Principal Investigator Name
Mercedes Latorre
Principal Investigator Email
mercedeslatorre@msn.com
Contact Person Name
Mercedes Latorre
Contact Person Email
mercedeslatorre@msn.com
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Gastroenterology and Hepatology Department
Principal Investigator Name
Luis Ibáñez Samaniego
Principal Investigator Email
lisamaniego@gmail.com
Contact Person Name
Luis Ibáñez Samaniego
Contact Person Email
lisamaniego@gmail.com
Site Name
Hospital Universitario Torrecardenas
Department Name
Hepatology Department
Principal Investigator Name
Marta Casado Martín
Principal Investigator Email
mm.casado.m@gmail.com
Contact Person Name
Marta Casado Martín
Contact Person Email
mm.casado.m@gmail.com
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Gastroenterology Department
Principal Investigator Name
Germán Soriano Pastor
Principal Investigator Email
gsoriano@santpau.cat
Contact Person Name
Germán Soriano Pastor
Contact Person Email
gsoriano@santpau.cat
Site Name
Hospital Unviersitario Miguel Servet
Department Name
Digestive Department
Principal Investigator Name
Vanesa Bernal Monterde
Principal Investigator Email
informacion.sector2@salud.aragon.es
Contact Person Name
Vanesa Bernal Monterde
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Digestive Department
Principal Investigator Name
Maria Teresa Arias Loste
Principal Investigator Email
ariasloste@gmail.com
Contact Person Name
Maria Teresa Arias Loste
Contact Person Email
ariasloste@gmail.com
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Digestive Department
Principal Investigator Name
David Marti Aguado
Principal Investigator Email
davidmmaa@gmail.com
Contact Person Name
David Marti Aguado
Contact Person Email
davidmmaa@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla (other listing)
Department Name
Digestive Department
Principal Investigator Name
Maria Teresa Arias Loste
Principal Investigator Email
ariasloste@gmail.com
Contact Person Name
Maria Teresa Arias Loste
Contact Person Email
ariasloste@gmail.com
Site Name
Hospital Universitario Marques De Valdecilla (additional)
Department Name
Digestive Department
Contact Person Name
placeholder

Poland

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
23-08-2024
Processing Time Days
53
Number Of Sites
8
Number Of Participants
22

Sites

Site Name
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Principal Investigator Name
Piotr Napora
Principal Investigator Email
napora.piotr@cbk.wroc.pl
Contact Person Name
Piotr Napora
Contact Person Email
napora.piotr@cbk.wroc.pl
Site Name
Synexus Polska Sp. z o.o. (Poznan)
Principal Investigator Name
Elżbieta Kołodziejska
Principal Investigator Email
Elzbieta.Kolodziejska@globalaes.com
Contact Person Name
Elżbieta Kołodziejska
Site Name
Synexus Polska Sp. z o.o. (Wroclaw)
Principal Investigator Name
Marek Dwojak
Principal Investigator Email
marek.dwojak@globalaes.com
Contact Person Name
Marek Dwojak
Contact Person Email
marek.dwojak@globalaes.com
Site Name
ID Clinic
Principal Investigator Name
Ewa Janczewska
Principal Investigator Email
e.jaczewska@poczta.fm
Contact Person Name
Ewa Janczewska
Contact Person Email
e.jaczewska@poczta.fm
Site Name
Pratia S.A.
Principal Investigator Name
Elżbieta Błach
Principal Investigator Email
eblach@pratia.pl
Contact Person Name
Elżbieta Błach
Contact Person Email
eblach@pratia.pl
Site Name
Synexus Polska Sp. z o.o. (Czestochowa)
Principal Investigator Name
Jarosław Ziebma
Principal Investigator Email
jaroslw.ziemba@globalaes.com
Contact Person Name
Jarosław Ziebma
Contact Person Email
jaroslw.ziemba@globalaes.com
Site Name
Synexus Polska Sp. z o.o. (Gdynia)
Principal Investigator Name
Anna Orkwiszewska-Nalewajko
Principal Investigator Email
anna.nalewajko@globalaes.com
Contact Person Name
Anna Orkwiszewska-Nalewajko
Contact Person Email
anna.nalewajko@globalaes.com
Site Name
Synexus Polska Sp. z o.o. (Lodz)
Principal Investigator Name
Marcin Ojrzanowski
Principal Investigator Email
Marcin.Ojrzanowski@globalaes.com
Contact Person Name
Marcin Ojrzanowski

Germany

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
26-08-2024
Processing Time Days
56
Number Of Sites
10
Number Of Participants
21

Sites

Site Name
Universitaetsklinikum Duesseldorf AöR
Department Name
Department of Gastroenterology, Hepatology and Infectious Diseases
Principal Investigator Name
Natalia Qvartskhava
Principal Investigator Email
natalia.qvartskhava@med.uni-duesseldorf.de
Contact Person Name
Natalia Qvartskhava
Site Name
Universitaetsklinikum des Saarlandes AöR
Department Name
Department of Medicine II
Principal Investigator Name
Jörn Schattenberg
Principal Investigator Email
Joern.Schattenberg@uks.eu
Contact Person Name
Jörn Schattenberg
Contact Person Email
Joern.Schattenberg@uks.eu
Site Name
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name
1st Department of Medicine
Principal Investigator Name
Jörn Schattenberg
Principal Investigator Email
joern.schattenberg@unimedizin-mainz.de
Contact Person Name
Jörn Schattenberg
Site Name
Gastroenterologie am Bayerischen Platz
Principal Investigator Name
Wolf Peter Hofmann
Principal Investigator Email
wolfpeter.hofmann@icloud.com
Contact Person Name
Wolf Peter Hofmann
Contact Person Email
wolfpeter.hofmann@icloud.com
Site Name
St. Josefs-Hospital Wiesbaden GmbH
Department Name
Liver outpatient department
Principal Investigator Name
Christoph Sarrazin
Principal Investigator Email
csarrazin@joho.de
Contact Person Name
Christoph Sarrazin
Contact Person Email
csarrazin@joho.de
Site Name
Eugastro GmbH
Principal Investigator Name
Ingolf Schiefke
Principal Investigator Email
ingolf.schiefke@eugastro.de
Contact Person Name
Ingolf Schiefke
Contact Person Email
ingolf.schiefke@eugastro.de
Site Name
Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
Principal Investigator Name
Keikawus Arasteh
Principal Investigator Email
keikawus.arasteh@epimed.org
Contact Person Name
Keikawus Arasteh
Contact Person Email
keikawus.arasteh@epimed.org
Site Name
Klinikum Chemnitz gGmbH
Principal Investigator Name
Till Wissniowski
Principal Investigator Email
t.wissniowski@skc.de
Contact Person Name
Till Wissniowski
Contact Person Email
t.wissniowski@skc.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Clinic for hepatology and gastroenterology
Principal Investigator Name
Münevver Demir
Principal Investigator Email
muenevver.demir@charite.de
Contact Person Name
Münevver Demir
Contact Person Email
muenevver.demir@charite.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Principal Investigator Name
Jens Marquardt
Principal Investigator Email
jens.marquardt@uksh.de
Contact Person Name
Jens Marquardt
Contact Person Email
jens.marquardt@uksh.de

France

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
22-08-2024
Processing Time Days
52
Number Of Sites
20
Number Of Participants
77

Sites

Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Service Hépato-Gastroenterologie et nutrition
Principal Investigator Name
Remi Collin
Principal Investigator Email
remi.collin@chu-limoges.fr
Contact Person Name
Remi Collin
Contact Person Email
remi.collin@chu-limoges.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des maladies des l’appareil digestif et de la nutrition
Principal Investigator Name
Philippe Mathurin
Principal Investigator Email
philippe.mathurin@chru-lille.fr
Contact Person Name
Philippe Mathurin
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Clinique Endocrinologie, Maladies Métaboliques et Nutrition
Principal Investigator Name
Bertrand Cariou
Principal Investigator Email
bertrand.cariou@univ-nantes.fr
Contact Person Name
Bertrand Cariou
Contact Person Email
bertrand.cariou@univ-nantes.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service Hépato-Gastroenterologie et Transplantation
Principal Investigator Name
Stéphanie Faure
Principal Investigator Email
s-faure@chu-montpellier.fr
Contact Person Name
Stéphanie Faure
Contact Person Email
s-faure@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Service Hépato-Gastroenterologie
Principal Investigator Name
Jérome Boursier
Principal Investigator Email
jeboursier@chu-angers.fr
Contact Person Name
Jérome Boursier
Contact Person Email
jeboursier@chu-angers.fr
Site Name
Besancon University Hospital Center
Department Name
Service Hépatologie
Principal Investigator Name
Vincent Di Martino
Principal Investigator Email
vdimartino@chu-besancon.fr
Contact Person Name
Vincent Di Martino
Contact Person Email
vdimartino@chu-besancon.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Service d’hépato-Gastro-entérologie et d’Assistance nutritive
Principal Investigator Name
Lawrence Serfaty
Principal Investigator Email
lawrence.serfaty@chru-strasbourg.fr
Contact Person Name
Lawrence Serfaty
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Service Hépato-gastroentérologie et oncologie digestive
Principal Investigator Name
Juliette Foucher
Principal Investigator Email
juliette.foucher@chu-bordeaux.fr
Contact Person Name
Juliette Foucher
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Service Hépatologie
Principal Investigator Name
Christophe Bureau
Principal Investigator Email
bureau.c@chu-toulouse.fr
Contact Person Name
Christophe Bureau
Contact Person Email
bureau.c@chu-toulouse.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Service Hépatologie
Principal Investigator Name
Vincent Leroy
Principal Investigator Email
vincent.leroy2@aphp.fr
Contact Person Name
Vincent Leroy
Contact Person Email
vincent.leroy2@aphp.fr
Site Name
Hopital Saint Antoine
Department Name
Pôle de référence Hépato-gastro-entérologie et oncologie digestive
Principal Investigator Name
Armelle Poujol-Robert
Principal Investigator Email
armelle.poujol-robert@aphp.fr
Contact Person Name
Armelle Poujol-Robert
Contact Person Email
armelle.poujol-robert@aphp.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service Hépato-Gastroenterologie
Principal Investigator Name
Edouard Bardou-Jacquet
Principal Investigator Email
edouard.bardou.jacquet@chu-rennes.fr
Contact Person Name
Edouard Bardou-Jacquet
Site Name
Hopital Saint Joseph
Department Name
Service Hépato-Gastroenterologie
Principal Investigator Name
Marc Bourlière
Principal Investigator Email
mbourliere@hopital-saint-joseph.fr
Contact Person Name
Marc Bourlière
Site Name
Clinique Pasteur
Department Name
Service gastro entérologie, endoscopie et maladies du foie
Principal Investigator Name
Maeva Guillaume
Principal Investigator Email
mguillaume@clinique-pasteur.com
Contact Person Name
Maeva Guillaume
Site Name
Hopital Beaujon
Department Name
Service Hépatologie
Principal Investigator Name
Laurent Castera
Principal Investigator Email
laurent.castera@aphp.fr
Contact Person Name
Laurent Castera
Contact Person Email
laurent.castera@aphp.fr
Site Name
Hopital Paul Brousse
Department Name
Service Gastro-entérologie et Hépatologie
Principal Investigator Name
Audrey Coilly
Principal Investigator Email
audrey.coilly@aphp.fr
Contact Person Name
Audrey Coilly
Contact Person Email
audrey.coilly@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Pôle de référence Hépato-gastroentérologie et oncologie digestive
Principal Investigator Name
Albert Tran
Principal Investigator Email
tran.a@chu-nice.fr
Contact Person Name
Albert Tran
Contact Person Email
tran.a@chu-nice.fr
Site Name
University Hospital Of Clermont-Ferrand
Department Name
Service Hépato-Gastroenterologie
Principal Investigator Name
Armando Abergel
Principal Investigator Email
aabergel@chu-clermontferrand.fr
Contact Person Name
Armando Abergel
Site Name
Hopital De La Croix Rousse
Department Name
Service Hépato-Gastroenterologie
Principal Investigator Name
Massimo Levrero
Principal Investigator Email
massimo.levrero@chu-lyon.fr
Contact Person Name
Massimo Levrero
Contact Person Email
massimo.levrero@chu-lyon.fr
Site Name
CHRU De Nancy
Department Name
Service Hépato-gastroentérologie
Principal Investigator Name
Jean-Pierre Bronowicki
Principal Investigator Email
jp.bronowicki@chru-nancy.fr
Contact Person Name
Jean-Pierre Bronowicki
Contact Person Email
jp.bronowicki@chru-nancy.fr

Portugal

Earliest CTIS Part Ii Submission Date
01-07-2024
Latest Decision Or Authorization Date
23-08-2024
Processing Time Days
53
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Internal Medicine Service
Principal Investigator Name
Filipe Andrade
Principal Investigator Email
filipe.andrade@ulsm.min-saude.pt
Contact Person Name
Filipe Andrade
Site Name
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Department Name
Gastroenterology department
Principal Investigator Name
Helena Cortez-Pinto
Principal Investigator Email
hlcortezpinto@gmail.com
Contact Person Name
Helena Cortez-Pinto
Contact Person Email
hlcortezpinto@gmail.com
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Gastroenterology service
Principal Investigator Name
Carla Rolanda
Principal Investigator Email
crolanda@med.uminho.pt
Contact Person Name
Carla Rolanda
Contact Person Email
crolanda@med.uminho.pt
Site Name
Centro Hospitalar Universitario Sao Joao E.P.E.
Department Name
Gastroenterology department
Principal Investigator Name
Guilherme Macedo
Principal Investigator Email
guilhermemacedo59@gmail.com
Contact Person Name
Guilherme Macedo
Contact Person Email
guilhermemacedo59@gmail.com
Site Name
Hospital Da Senhora Da Oliveira Guimaraes E.P.E.
Department Name
Gastroenterology department
Principal Investigator Name
Joana Magalhães
Principal Investigator Email
joanaltmagalhaes@gmail.com
Contact Person Name
Joana Magalhães
Contact Person Email
joanaltmagalhaes@gmail.com
Site Name
Centro Hospitalar De Tras-Os-Montes E Alto Douro E.P.E.
Department Name
Hepatology service
Principal Investigator Name
José Presa
Principal Investigator Email
josepresa@gmail.com
Contact Person Name
José Presa
Contact Person Email
josepresa@gmail.com

Sponsor

Primary sponsor

Full Name
Inventiva
Organisation Type
Pharmaceutical company
Country Of Registered Address
France

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
Multiple operational sponsor duties (codes listed in CTIS record; e.g. study management, monitoring, data management as indicated by sponsorDuties codes)
Name
United BioSource (Suisse) SA
Responsibilities
Safety/data-related responsibilities indicated by sponsorDuties code '8' (as listed)
Name
Synexus Clinical Research GmbH
Responsibilities
Screening and recruitment support at selected sites

Third parties

  • {"country":"Greece","full_name":"National And Kapodistrian University Of Athens","duties_or_roles":"Liver biopsis central reader","organisation_type":"Educational Institution"}
  • {"country":"United States","full_name":"Inova Healthcare Services","duties_or_roles":"Liver biopsis central reader","organisation_type":"Industry"}
  • {"country":"France","full_name":"Cerba","duties_or_roles":"Sponsor duty code '4' (as listed)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Germany","full_name":"Synexus Clinical Research GmbH","duties_or_roles":"Screening and recruitment of patients in some selected sites","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Austria","full_name":"Karoline Lackner","duties_or_roles":"Liver biopsis central reader","organisation_type":"Health care"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Multiple sponsor duties (codes listed) — operational/CRO responsibilities (detailed roles given as sponsorDuties codes in CTIS record)","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Charles River Laboratories Saint-Nazaire","duties_or_roles":"Analysis of lanifibranor and its metabolites","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Perspectum Limited","duties_or_roles":"Medical image analysis/review-MRI etc","organisation_type":"Health care"}
  • {"country":"France","full_name":"Phinc Development","duties_or_roles":"Pharmacokinetics analysis","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"Sponsor duty code '4' (as listed)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"France","full_name":"Cardiabase","duties_or_roles":"ECG analysis/review","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"United BioSource (Suisse) SA","duties_or_roles":"Sponsor duty code '8' (as listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Idiotiko Iatreio Prodromou Chytiroglou L.P.","duties_or_roles":"Liver biopsis central reader","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Lanifibranor clinical
Active Substance
LANIFIBRANOR
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Clinical product (no marketing authorisation specified in CTIS record)
Maximum Dose
1200 mg (max daily dose amount)
Investigational Product Name
PL1 (placebo)
Modality
Other
Authorisation Status
Placebo (not an authorised active medicinal product)

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