Clinical trial • Gastroenterology

SELADELPAR for Primary biliary cholangitis | Compensated cirrhosis

Clinical trial of SELADELPAR for Primary biliary cholangitis | Compensated cirrhosis.

Overview

Trial Therapeutic Area
Gastroenterology
Trial Disease
Primary biliary cholangitis | Compensated cirrhosis
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
28-02-2025
First CTIS Authorization Date
23-06-2025

Trial design

Randomised, seladelpar 10 mg capsule (oral) and seladelpar 5 mg capsule (oral); comparators: placebo to match 10 mg (oral) and placebo to match 5 mg (oral).-controlled trial in Greece, Czechia, Spain and others.

Randomised
Yes
Comparator
Seladelpar 10 mg capsule (oral) and Seladelpar 5 mg capsule (oral); comparators: Placebo to match 10 mg (oral) and Placebo to match 5 mg (oral).
Target Sample Size
50
Trial Duration For Participant
1092

Eligibility

Recruits 50 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and consent documents include pregnancy- and infant-specific ICFs (e.g. 'Pregnancy and Infant ICF', 'Pregnant Participant ICF', 'Pregnant Partner ICF') and optional-consent forms (PK, liver biopsy, future research) in multiple country-specific languages; no further explicit consent/assent handling text is available in the provided JSON..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and consent documents include pregnancy- and infant-specific ICFs (e.g. 'Pregnancy and Infant ICF', 'Pregnant Participant ICF', 'Pregnant Partner ICF') and optional-consent forms (PK, liver biopsy, future research) in multiple country-specific languages; no further explicit consent/assent handling text is available in the provided JSON.

Inclusion criteria

  • {"criterion_text":"- Must be at least 18 years old.\n- Must have a confirmed prior diagnosis of PBC\n- Evidence of cirrhosis\n- CP class A or B\n- Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose\n- Subjects must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)"}

Exclusion criteria

  • {"criterion_text":"- Prior exposure to seladelpar\n- A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study\n- History of liver transplantation or actively listed for cadaveric or planned living donor transplant.\n- Decompensated cirrhosis\n- Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI\n- Hospitalization for liver-related complication within 12 weeks of Screening\n- Laboratory parameters during screening: a. ALP < 1.5× ULN b. TB ≤0.6×ULN or ≥5×ULN c. TB ≥ 5× ULN d. Platelet count ≤ 50×103/μL e. Albumin ≤ 2.8 g/dL f. Estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2 g. MELD score > 12. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take anticoagulant use into account, h. Serum alpha-fetoprotein (AFP) > 20 ng/mL i. INR > 1.7\n- CP-C cirrhosis\n- History or presence of other concomitant liver diseases"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- EFS as measured by the time from start of treatment to the first occurrence of any of the following adjudicated events up to week 156: a. Death by any cause b. Liver transplantation c. MELD Score ≥ 15 d. Ascites requiring treatment e. Hospitalization for any of the following qualifying events: i.Esophageal or gastric variceal bleeding ii.Hepatic encephalopathy iii. Spontaneous bacterial peritonitis","definition_or_measurement_approach":"EFS is defined as the time from start of treatment to the first occurrence of any of the following adjudicated events up to Week 156: Death by any cause; Liver Transplantation; MELD Score ≥ 15; Ascites Requiring Treatment; Hospitalization for qualifying events (Esophageal or gastric variceal bleeding; Hepatic encephalopathy; Spontaneous bacterial peritonitis)."}

Secondary endpoints

  • {"endpoint_text":"- Overall survival, defined as time from start of treatment to death from any cause up to Week 156","definition_or_measurement_approach":"Overall survival measured as time from start of treatment to death from any cause up to Week 156."}
  • {"endpoint_text":"- LTFS, defined as time from start of treatment to the first occurrence of any of the following up to Week 156: a. Liver-related death b. Liver transplantation","definition_or_measurement_approach":"LTFS measured as time from start of treatment to first occurrence of liver-related death or liver transplantation up to Week 156."}
  • {"endpoint_text":"- Time to hospitalization for qualifying PBC clinical events from start of treatment up to Week 156:","definition_or_measurement_approach":"Time from start of treatment to hospitalization for qualifying PBC clinical events (esophageal/gastric variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis) up to Week 156."}
  • {"endpoint_text":"- Time to each of the other adjudicated PBC clinical events from start of treatment up to Week 156: a. MELD Score ≥ 15 b. Ascites requiring treatment","definition_or_measurement_approach":"Time from start of treatment to each adjudicated PBC clinical event (MELD ≥15; ascites requiring treatment) up to Week 156."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
50
Recruitment Window Months
54
Consent Approach
Informed consent is obtained using country-specific Main ICF documents (Main ICFs available in local languages for each participating country). Additional ICFs exist for pregnant participants, pregnant partners, optional PK sampling, optional liver biopsy, and optional future research. Consent materials and patient-facing documents are provided in multiple languages as listed (e.g., Greek, English, Spanish, French, German, Italian, Polish, Portuguese, Czech, Hungarian, Romanian, Danish, Dutch). Participants are adults (≥18 years) and provide their own consent; pregnancy-related partner and infant forms are provided where applicable. No detailed assent procedures for minors are present (study requires ≥18 years).

Methods

  • Country-specific recruitment arrangements documents (K1) and brochures (K2) — local site-based recruitment materials
  • Doctor/GP referral letters (country-specific K2/Study Doctor Referral Letter documents listed for Greece, Czechia, Spain, Hungary, Italy, France, Belgium, Portugal, etc.)
  • Patient brochures/study brochures in multiple languages (country-specific K2 brochure documents)
  • Appointment cards and patient cards (K2 / L2 documents: Appointment Card, Patient Card) to support scheduling and retention
  • Scout Clinical communications (email communications and study brochure) used in some countries (e.g., Czechia) for outreach
  • Site-level best-practice guides for recruitment
  • Country-specific plain-language protocol synopses and ICF materials to inform potential participants

Geography

Total Number Of Sites
60
Total Number Of Participants
118

Greece

Earliest CTIS Part Ii Submission Date
09-05-2025
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
306
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
4th Department of Internal Medicine
Principal Investigator Name
Emmanouil Sinakos
Principal Investigator Email
pqre@ippokratio.gr
Contact Person Name
Emmanouil Sinakos
Contact Person Email
pqre@ippokratio.gr
Site Name
General University Hospital Of Larissa
Department Name
Department of Medicine & Research Laboratory of Internal Medicine
Principal Investigator Name
George Dalekos
Principal Investigator Email
georgedalekos@gmail.com
Contact Person Name
George Dalekos
Contact Person Email
georgedalekos@gmail.com
Site Name
Evangelismos S.A.
Department Name
Gastroenterology Department
Principal Investigator Name
Nikolaos Viazis
Principal Investigator Email
nikos.viazis@gmail.com
Contact Person Name
Nikolaos Viazis
Contact Person Email
nikos.viazis@gmail.com

Czechia

Earliest CTIS Part Ii Submission Date
26-05-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
288
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Fakultni Nemocnice Ostrava
Department Name
Interní a kardiologická klinika
Principal Investigator Name
Adam Vašura
Principal Investigator Email
adam.vasura@fno.cz
Contact Person Name
Adam Vašura
Contact Person Email
adam.vasura@fno.cz
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
klinika gastroenterologie a hepatologie
Principal Investigator Name
Radan Brůha
Principal Investigator Email
radan.bruha@vfn.cz
Contact Person Name
Radan Brůha
Contact Person Email
radan.bruha@vfn.cz
Site Name
Research Site s.r.o.
Department Name
Research Site s.r.o.
Principal Investigator Name
Václav Hejda
Principal Investigator Email
hejdav@fnplzen.cz
Contact Person Name
Václav Hejda
Contact Person Email
hejdav@fnplzen.cz

Spain

Earliest CTIS Part Ii Submission Date
28-05-2025
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
292
Number Of Sites
10
Number Of Participants
10

Sites

Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Digestive
Principal Investigator Name
Conrado Fernandez Rodriguez
Principal Investigator Email
cfernandez@fhalcorcon.es
Contact Person Name
Conrado Fernandez Rodriguez
Contact Person Email
cfernandez@fhalcorcon.es
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Digestive
Principal Investigator Name
Esther Molina Perez
Principal Investigator Email
esther.molina.perez@sergas.es
Contact Person Name
Esther Molina Perez
Contact Person Email
esther.molina.perez@sergas.es
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Alvaro Diaz Gonzalez
Principal Investigator Email
alvaro.diaz@scsalud.es
Contact Person Name
Alvaro Diaz Gonzalez
Contact Person Email
alvaro.diaz@scsalud.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Internal Medicine
Principal Investigator Name
Ares Villagrasa
Principal Investigator Email
aresaurora.villagrasa@vallhebron.cat
Contact Person Name
Ares Villagrasa
Site Name
Hospital Universitario Reina Sofia
Department Name
Digestive
Principal Investigator Name
Jose Luis Montero
Principal Investigator Email
jlm14005623@gmail.com
Contact Person Name
Jose Luis Montero
Contact Person Email
jlm14005623@gmail.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Raul Andrade
Principal Investigator Email
andrade@uma.es
Contact Person Name
Raul Andrade
Contact Person Email
andrade@uma.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
Javier Ampuero Herrojo
Principal Investigator Email
javi.ampuero@gmail.com
Contact Person Name
Javier Ampuero Herrojo
Contact Person Email
javi.ampuero@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Hepatology Unit
Principal Investigator Name
Maria Carlota Londoño
Principal Investigator Email
MLONDONO@clinic.cat
Contact Person Name
Maria Carlota Londoño
Contact Person Email
MLONDONO@clinic.cat
Site Name
Hospital Del Mar
Department Name
Gastroenterology
Principal Investigator Name
Montserrat Garcia-Retortillo
Principal Investigator Email
mgarciaretortillo@parcdesalutmar.cat
Contact Person Name
Montserrat Garcia-Retortillo
Site Name
Hospital Germans Trias I Pujol
Department Name
Hepatology
Principal Investigator Name
Rosa Maria Morillas
Principal Investigator Email
rmorillas.germanstrias@gencat.net
Contact Person Name
Rosa Maria Morillas

Hungary

Earliest CTIS Part Ii Submission Date
19-05-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
298
Number Of Sites
2
Number Of Participants
4

Sites

Site Name
Semmelweis University
Department Name
Sebeszeti es Intervencios Gasztroenterologiai Klinika
Principal Investigator Name
Krisztina HAGYMASI
Principal Investigator Email
hagymasi.krisztina@semmelweis.hu
Contact Person Name
Krisztina HAGYMASI
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Principal Investigator Name
Zsolt SZINKU
Principal Investigator Email
evims1020@gmail.com
Contact Person Name
Zsolt SZINKU
Contact Person Email
evims1020@gmail.com

Poland

Earliest CTIS Part Ii Submission Date
04-06-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
282
Number Of Sites
2
Number Of Participants
10

Sites

Site Name
Planetmed Sp. z o.o.
Principal Investigator Name
Barbara Woźniak-Stolarska
Principal Investigator Email
basiastolarska@interia.pl
Contact Person Name
Barbara Woźniak-Stolarska
Contact Person Email
basiastolarska@interia.pl
Site Name
ID Clinic Arkadiusz Pisula
Principal Investigator Name
Ewa Janczewska
Principal Investigator Email
e.janczewska@poczta.fm
Contact Person Name
Ewa Janczewska
Contact Person Email
e.janczewska@poczta.fm

Belgium

Earliest CTIS Part Ii Submission Date
23-05-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
291
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Gastroenterology & Hepatology
Principal Investigator Name
Xavier Verhelst
Principal Investigator Email
xavier.verhelst@uzgent.be
Contact Person Name
Xavier Verhelst
Contact Person Email
xavier.verhelst@uzgent.be
Site Name
Universitair Ziekenhuis Antwerpen
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 and 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

Austria

Earliest CTIS Part Ii Submission Date
15-05-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
302
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Medical University Of Vienna
Department Name
Medicine III, Division of Gastroenterology and Hepatology
Principal Investigator Name
Michael Trauner
Principal Investigator Email
michael.trauner@meduniwien.ac.at
Contact Person Name
Michael Trauner
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Int. Medicine I, Div. of Gastroenterology & Hepatology, Rheumatology, Endocrinology & Diabetes Care
Principal Investigator Name
Harald Hofer
Principal Investigator Email
harald.hofer@klinikum-wegr.at
Contact Person Name
Harald Hofer
Contact Person Email
harald.hofer@klinikum-wegr.at
Site Name
Tirol Kliniken GmbH
Department Name
Internal Medicine
Principal Investigator Name
Ivo Graziadei
Principal Investigator Email
ivo.graziadei@tirol-kliniken.at
Contact Person Name
Ivo Graziadei
Site Name
Krankenhaus Der Barmherzigen Brueder Wien
Department Name
Internal Medicine I, Gastroenterology and Hepatology
Principal Investigator Name
Arnulf Ferlitsch
Principal Investigator Email
arnulf.ferlitsch@bbwien.at
Contact Person Name
Arnulf Ferlitsch
Contact Person Email
arnulf.ferlitsch@bbwien.at

Romania

Earliest CTIS Part Ii Submission Date
12-03-2025
Latest Decision Or Authorization Date
16-03-2026
Processing Time Days
369
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Institutul Clinic Fundeni
Department Name
Gastroenterologie III
Principal Investigator Name
Liliana-Simona Gheorghe
Principal Investigator Email
drlgheorghe@gmail.com
Contact Person Name
Liliana-Simona Gheorghe
Contact Person Email
drlgheorghe@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
21-05-2025
Latest Decision Or Authorization Date
13-03-2026
Processing Time Days
296
Number Of Sites
10
Number Of Participants
15

Sites

Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Clinica di Gastroenterologia
Principal Investigator Name
Marco Marzioni
Principal Investigator Email
m-marzioni@staff.univpm.it
Contact Person Name
Marco Marzioni
Contact Person Email
m-marzioni@staff.univpm.it
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
UOC di Medicina Interna Metabolica Nutrizionale
Principal Investigator Name
Filippo Gabrielli
Principal Investigator Email
gabrielli.filippo@unimore.it
Contact Person Name
Filippo Gabrielli
Contact Person Email
gabrielli.filippo@unimore.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Surgery Oncology and Gastroenterology
Principal Investigator Name
Nora Cazzagon
Principal Investigator Email
nora.cazzagon@unipd.it
Contact Person Name
Nora Cazzagon
Contact Person Email
nora.cazzagon@unipd.it
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Epatologia
Principal Investigator Name
Maurizia Rossana Brunetto
Principal Investigator Email
maurizia.brunetto@unipi.it
Contact Person Name
Maurizia Rossana Brunetto
Contact Person Email
maurizia.brunetto@unipi.it
Site Name
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Department Name
U.O.C. di Gastroenterologia
Principal Investigator Name
Vincenza Calvaruso
Principal Investigator Email
vincenza.calvaruso@unipa.it
Contact Person Name
Vincenza Calvaruso
Contact Person Email
vincenza.calvaruso@unipa.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
S.C. Gastroenterologia
Principal Investigator Name
Pietro Invernizzi
Principal Investigator Email
pietro.invernizzi@unimib.it
Contact Person Name
Pietro Invernizzi
Contact Person Email
pietro.invernizzi@unimib.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
SC 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
Casa Sollievo Della Sofferenza
Department Name
UOSD di Epatologia, Scienze Mediche
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
Azienda Socio Sanitaria Territoriale Santi Paolo E Carlo
Department Name
Medicine and Liver Gastroenterology Unit
Principal Investigator Name
Pier Maria Battezzati
Principal Investigator Email
piermaria.battezzati@unimi.it
Contact Person Name
Pier Maria Battezzati
Contact Person Email
piermaria.battezzati@unimi.it
Site Name
National Institute Of Gastroenterology Saverio De Bellis Research Hospital
Department Name
UOSVD “Epatopatie"
Principal Investigator Name
Francesco Losito
Principal Investigator Email
francesco.losito@irccsdebellis.it
Contact Person Name
Francesco Losito

France

Earliest CTIS Part Ii Submission Date
30-05-2025
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
286
Number Of Sites
9
Number Of Participants
23

Sites

Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Pôle Hépato-Digestif
Principal Investigator Name
François HABERSETZER
Principal Investigator Email
francois.habersetzer@chru-strasbourg.fr
Contact Person Name
François HABERSETZER
Site Name
Hospices Civils De Lyon
Department Name
Service d’Hépatologie et Gastroentérologie
Principal Investigator Name
Domitille ERARD
Principal Investigator Email
domitille.erard@chu-lyon.fr
Contact Person Name
Domitille ERARD
Contact Person Email
domitille.erard@chu-lyon.fr
Site Name
CHRU De Nancy
Department Name
Hepato-Gastro-Enterology
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
Site Name
Hopital Paul Brousse
Department Name
Service Centre d’Hépato-Biliaire
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
Assistance Publique Hopitaux De Paris (Bobigny)
Department Name
Service d’hépatologie
Principal Investigator Name
Nathalie GANNE-CARRIE
Principal Investigator Email
nathalie.ganne@aphp.fr
Contact Person Name
Nathalie GANNE-CARRIE
Contact Person Email
nathalie.ganne@aphp.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Service d’Hépato-Gastroentérologie et Transplantation
Principal Investigator Name
Lucy MEUNIER
Principal Investigator Email
lucy.meunier@chu-montpellier.fr
Contact Person Name
Lucy MEUNIER
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Service des Maladies de l’Appareil Digestif et de la Nutrition
Principal Investigator Name
Alexandre LOUVET
Principal Investigator Email
alexandre.louvet@chu-lille.fr
Contact Person Name
Alexandre LOUVET
Contact Person Email
alexandre.louvet@chu-lille.fr
Site Name
Assistance Publique Hopitaux De Paris (Creteil)
Department Name
Service d’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
Assistance Publique Hopitaux De Paris (Paris)
Department Name
Centre de Référence des maladies inflammatoires des voies biliaires et des hépatites auto-immunes
Principal Investigator Name
Christophe CORPECHOT
Principal Investigator Email
Christophe.corpechot@aphp.fr
Contact Person Name
Christophe CORPECHOT
Contact Person Email
Christophe.corpechot@aphp.fr

Germany

Earliest CTIS Part Ii Submission Date
30-05-2025
Latest Decision Or Authorization Date
11-03-2026
Processing Time Days
285
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Gastroenterologisch-Hepatologisches MVZ Kiel GmbH
Department Name
Gastroenterologisch Hepatologisches Zentrum
Principal Investigator Name
Holger Hinrichsen
Contact Person Name
Holger Hinrichsen
Site Name
Universitaetsklinikum Regensburg AöR
Department Name
Klinik und Poliklinik für Innere Med
Principal Investigator Name
Stephan Schmid
Principal Investigator Email
stephan.schmid@ukr.de
Contact Person Name
Stephan Schmid
Contact Person Email
stephan.schmid@ukr.de
Site Name
Universitaet Des Saarlandes
Department Name
Klinik für Innere Medizin 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
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik m.S. Hepatologie und Gastroenterologie
Principal Investigator Name
Münevver Demir
Principal Investigator Email
muenevver.demir@charite.de
Contact Person Name
Münevver Demir
Contact Person Email
muenevver.demir@charite.de

Denmark

Earliest CTIS Part Ii Submission Date
23-05-2025
Latest Decision Or Authorization Date
10-03-2026
Processing Time Days
291
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Aarhus University Hospital
Department Name
Department of Hepatology and Gastroenterology
Principal Investigator Name
Karen Louise Thomsen
Principal Investigator Email
karethom@rm.dk
Contact Person Name
Karen Louise Thomsen
Contact Person Email
karethom@rm.dk

Portugal

Earliest CTIS Part Ii Submission Date
17-04-2026
Latest Decision Or Authorization Date
07-05-2026
Processing Time Days
20
Number Of Sites
8
Number Of Participants
8

Sites

Site Name
Hospital Da Luz S.A.
Department Name
Gastroenterology Department
Principal Investigator Name
Joana Nunes
Principal Investigator Email
j.mnunes@hospitaldaluz.pt
Contact Person Name
Joana Nunes
Contact Person Email
j.mnunes@hospitaldaluz.pt
Site Name
Unidade Local De Saude De Coimbra E.P.E.
Department Name
Internal Medicine Department
Principal Investigator Name
João Madaleno
Principal Investigator Email
joaomadaleno@ulscoimbra.min-saude.pt
Contact Person Name
João Madaleno
Site Name
Unidade Local De Saude De Santo Antonio E.P.E.
Department Name
Gastroenterology Department
Principal Investigator Name
Luís Maia
Principal Investigator Email
u11004@ulssa.min-saude.pt
Contact Person Name
Luís Maia
Contact Person Email
u11004@ulssa.min-saude.pt
Site Name
Unidade Local De Saude De Tras-Os-Montes E Alto Douro E.P.E.
Department Name
Internal Medicine Department
Principal Investigator Name
José Presa Ramos
Principal Investigator Email
jpresa@chtmad.min-saude.pt
Contact Person Name
José Presa Ramos
Contact Person Email
jpresa@chtmad.min-saude.pt
Site Name
Unidade Local De Saude De Matosinhos E.P.E.
Department Name
Internal Medicine Department
Principal Investigator Name
Filipe Andrade
Principal Investigator Email
filipe.andrade@ulsm.min-saude.pt
Contact Person Name
Filipe Andrade
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Gastroenterology Department
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
Unidade Local De Saude Do Alto Ave E.P.E.
Department Name
Gastroenterology Department
Principal Investigator Name
Joana Magalhães
Principal Investigator Email
3401@ulsaave.min-saude.pt
Contact Person Name
Joana Magalhães
Contact Person Email
3401@ulsaave.min-saude.pt
Site Name
Unidade Local De Saude De Santo Antonio E.P.E. (Porto entry duplicate grouping)
Department Name
Gastroenterology Department
Principal Investigator Name
Luís Maia
Principal Investigator Email
u11004@ulssa.min-saude.pt
Contact Person Name
Luís Maia
Contact Person Email
u11004@ulssa.min-saude.pt

Sponsor

Primary sponsor

Full Name
Gilead Sciences Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Global Ltd.
Responsibilities
codes: [1,12,5]

Third parties

  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"codes: [1,12,5]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"eCOA Services; code: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"PK Lab","organisation_type":"Pharmaceutical company"}
  • {"country":"Belgium","full_name":"MEDPACE LABORATORIES","duties_or_roles":"Central Lab","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Singapore","full_name":"Medpace Singapore Pte. Ltd","duties_or_roles":"Central Lab","organisation_type":"Health care"}
  • {"country":"United States","full_name":"Medpace Reference Laboratories LLC","duties_or_roles":"Central Lab","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Edetek Inc.","duties_or_roles":"code: 7","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"Biopsy Services","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
MBX-8025 10 mg capsule
Active Substance
SELADELPAR
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (euMpNumber PRD1850261 present)
Orphan Designation
Yes
Starting Dose
10 mg
Dose Levels
10 mg
Maximum Dose
10 mg
Investigational Product Name
MBX-8025 5 mg capsule
Active Substance
SELADELPAR
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Authorisation Status
Authorised (euMpNumber PRD1850260 present)
Orphan Designation
Yes
Starting Dose
5 mg
Dose Levels
5 mg
Maximum Dose
5 mg

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