Clinical trial • Phase II • Other

VAMIFEPORT TRIHYDROCHLORIDE for HFE-related hereditary haemochromatosis | Hereditary haemochromatosis

Phase II trial of VAMIFEPORT TRIHYDROCHLORIDE for HFE-related hereditary haemochromatosis | Hereditary haemochromatosis.

Overview

Trial Therapeutic Area
Other
Trial Disease
HFE-related hereditary haemochromatosis | Hereditary haemochromatosis
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
12-12-2025
First CTIS Authorization Date
20-04-2026

Trial design

Randomised, vamifeport low dose — oral, twice daily (bid) up to day 360; vamifeport high dose — oral, twice daily (bid) up to day 360; placebo matching vamifeport low and high doses — oral, bid up to day 360.-controlled Phase II trial across 50 sites in Austria, Belgium, Czechia and others.

Randomised
Yes
Comparator
Vamifeport Low Dose — oral, twice daily (BID) up to Day 360; Vamifeport High Dose — oral, twice daily (BID) up to Day 360; Placebo matching vamifeport low and high doses — oral, BID up to Day 360.
Target Sample Size
31
Trial Duration For Participant
360

Eligibility

Recruits 31 No vulnerable populations selected; participants are adults (≥ 18) and must provide written informed consent. No assent or paediatric consent procedures are described..

Vulnerable Population
No vulnerable populations selected; participants are adults (≥ 18) and must provide written informed consent. No assent or paediatric consent procedures are described.

Inclusion criteria

  • {"criterion_text":"- 1. Adult (≥ 18 years) and has provided written informed consent.\n- 2. Confirmed diagnosis of HFE-HH in medical history.\n- 3. Evidence of iron overload as shown by: • TSAT > 45% (confirmed at 2 visits, at least 14 days apart) at Screening; and • Serum ferritin ≥ 200 ng/mL and < 5000 ng/mL (confirmed at 2 visits, at least 14 days apart) at Screening; and • MRI-based LIC between 3 and 16 mg/g (53.7 and 286.5 mmol/kg) dry weight (dw) at Screening.\n- 4. Body mass index between 18.5 and 32 kilograms per meter squared (kg/m^2)."}

Exclusion criteria

  • {"criterion_text":"- 1. Clinically relevant laboratory abnormalities, 12-lead electrocardiogram (ECG) findings, or medical history."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline in magnetic resonance imaging (MRI)-based liver iron concentration (LIC) ,","definition_or_measurement_approach":"Measured by magnetic resonance imaging (MRI)-based liver iron concentration (LIC); change from baseline in MRI-based LIC."}

Recruitment

Registry Or Advocacy Recruitment
True, Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Digital Remote Recruitment
True, includes social media advertising, email campaigns, SMS, online/mobile landing pages, mobile landing pages, online primary-screener and consent materials, and digital re-engagement materials (country-specific).
Planned Sample Size
50
Recruitment Window Months
26
Consent Approach
Written informed consent is required from adult participants (≥18). Main informed consent forms (Main ICF) and related consent documents (e.g. Pregnancy Follow-Up ICF, Pregnant Partner ICF, GDPR-ICF, optional future research ICF) are provided; ICFs and study information materials are available in multiple country/language-specific versions (examples in repository: English, German, French, Dutch, Polish, Spanish, Italian, Czech, Romanian, etc.). No paediatric assent procedures are described.

Methods

  • Social media ads (country-specific versions indicated in documents: AUT, BEL, CZE, NLD, FRA, DEU, IRL, ITA, POL, RO, ESP)
  • SMS messaging (country-specific versions)
  • Email campaigns (country-specific versions)
  • Direct mail (country-specific versions)
  • Banners and digital display (country-specific versions)
  • Autocall / outbound phone calls (AUT, BEL, CZE, DEU, etc.)
  • Landing pages and mobile landing pages (country-specific)
  • Flyers, flipcharts and recruitment brochures (country-specific)
  • Patient letters and doctor letters (country-specific)
  • Primary screener (telephone/online) and primary-screener consent procedures
  • Reengagement packages
  • PAG / patient advocacy engagement materials (PAG emails, PAG kits)
  • Keyword search and digital outreach (documented for IRL)

Geography

Total Number Of Sites
50
Total Number Of Participants
50

Austria

Earliest CTIS Part Ii Submission Date
06-04-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
21
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Ordensklinikum Linz GmbH
Department Name
Abteilung Interne IV
Principal Investigator Name
Stephanie Hametner-Schreil
Contact Person Name
Stephanie Hametner-Schreil
Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitaetsklinik für Innere Medizin I
Principal Investigator Name
Benedikt Schaefer
Principal Investigator Email
benedikt.schaefer@i-med.ac.at
Contact Person Name
Benedikt Schaefer
Contact Person Email
benedikt.schaefer@i-med.ac.at
Site Name
Medical University Of Vienna
Department Name
Abteilung für Innere Medizin III Gastroenterologie und Hepatologie
Principal Investigator Name
Albert Staettermayer
Contact Person Name
Albert Staettermayer

Belgium

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
30
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Gastro-enterology & Hepatology
Principal Investigator Name
Thomas Vanwolleghem
Principal Investigator Email
thomas.vanwolleghem@uza.be
Contact Person Name
Thomas Vanwolleghem
Contact Person Email
thomas.vanwolleghem@uza.be
Site Name
UZ Brussel
Department Name
Gastro-enterology
Principal Investigator Name
Hendrik Reynaert
Principal Investigator Email
hendrik.reynaert@uzbrussel.be
Contact Person Name
Hendrik Reynaert
Contact Person Email
hendrik.reynaert@uzbrussel.be
Site Name
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name
Hematology
Principal Investigator Name
Wivine Bernard
Principal Investigator Email
wivine.bernard@chuuclnamur.uclouvain.be
Contact Person Name
Wivine Bernard
Site Name
Universitair Ziekenhuis Gent
Department Name
Gastro-enterology
Principal Investigator Name
Hans Van Vlierberghe
Principal Investigator Email
hans.vanvlierberghe@uzgent.be
Contact Person Name
Hans Van Vlierberghe
Contact Person Email
hans.vanvlierberghe@uzgent.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Hematology
Principal Investigator Name
Gaëlle Vertenoeil
Principal Investigator Email
gaelle.vertenoeil@chuliege.be
Contact Person Name
Gaëlle Vertenoeil
Contact Person Email
gaelle.vertenoeil@chuliege.be

Czechia

Earliest CTIS Part Ii Submission Date
22-03-2026
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
30
Number Of Sites
3
Number Of Participants
3

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
Fakultni Nemocnice Brno
Department Name
Oddělení klinické hematologie
Principal Investigator Name
Jan Kamelander
Principal Investigator Email
kamelander.jan@fnbrno.cz
Contact Person Name
Jan Kamelander
Contact Person Email
kamelander.jan@fnbrno.cz
Site Name
Institute For Clinical And Experimental Medicine
Department Name
Klinika hepatogastroenterologie
Principal Investigator Name
Jan Šperl
Principal Investigator Email
jan.sperl@ikem.cz
Contact Person Name
Jan Šperl
Contact Person Email
jan.sperl@ikem.cz

Netherlands

Earliest CTIS Part Ii Submission Date
23-03-2026
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
28
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Radboud universitair medisch centrum Stichting
Department Name
Internal Medicine
Principal Investigator Name
Alexander Rennings
Principal Investigator Email
Alexander.Rennings@radboudumc.nl
Contact Person Name
Alexander Rennings

Poland

Earliest CTIS Part Ii Submission Date
17-03-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
37
Number Of Sites
3
Number Of Participants
3

Sites

Site Name
Instytut Hematologii I Transfuzjologii
Principal Investigator Name
Ewa Lech-Marańda
Principal Investigator Email
emaranda@ihit.waw.pl
Contact Person Name
Ewa Lech-Marańda
Contact Person Email
emaranda@ihit.waw.pl
Site Name
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Department Name
Oddział Hematologiczny
Principal Investigator Name
Aleksandra Butrym
Principal Investigator Email
aleksandra.butrym@gmail.com
Contact Person Name
Aleksandra Butrym
Contact Person Email
aleksandra.butrym@gmail.com
Site Name
Provincial Specialist Hospital Them. J. Gromkowski
Principal Investigator Name
Grzegorz Mazur
Principal Investigator Email
grzegorzmaz@yahoo.com
Contact Person Name
Grzegorz Mazur
Contact Person Email
grzegorzmaz@yahoo.com

France

Earliest CTIS Part Ii Submission Date
12-03-2026
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
42
Number Of Sites
10
Number Of Participants
9

Sites

Site Name
Hopital Paul Brousse
Department Name
Gastro-enterology and Hepatology department
Principal Investigator Name
Rodolphe SOBESKY
Principal Investigator Email
rodolphe.sobesky@aphp.fr
Contact Person Name
Rodolphe SOBESKY
Contact Person Email
rodolphe.sobesky@aphp.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Hepatology department
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
Centre Hospitalier Regional De Marseille
Department Name
Hepatology department
Principal Investigator Name
René GEROLAMI
Principal Investigator Email
rene.gerolami@ap-hm.fr
Contact Person Name
René GEROLAMI
Contact Person Email
rene.gerolami@ap-hm.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Hepatology department
Principal Investigator Name
Nathalie GANNE-CARRIÉ
Principal Investigator Email
nathalie.ganne@aphp.fr
Contact Person Name
Nathalie GANNE-CARRIÉ
Contact Person Email
nathalie.ganne@aphp.fr
Site Name
Hospices Civils De Lyon
Department Name
lnternal Medicine and Vascular Pathology department
Principal Investigator Name
Quitterie REYNAUD
Principal Investigator Email
quitterie.reynaud@chu-lyon.fr
Contact Person Name
Quitterie REYNAUD
Contact Person Email
quitterie.reynaud@chu-lyon.fr
Site Name
Centre Hospitalier De Saint-Brieuc
Department Name
Gastroenterology and hepatology department
Principal Investigator Name
Antonia LE GRUYER
Principal Investigator Email
Antonia.legruyer@armorsante.bzh
Contact Person Name
Antonia LE GRUYER
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Liver disease department
Principal Investigator Name
Edouard BARDOU-JACQUET
Principal Investigator Email
edouard.bardou.jacquet@chu-rennes.fr
Contact Person Name
Edouard BARDOU-JACQUET
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Hepato-Gastro-Enterology department
Principal Investigator Name
Paul CARRIER
Principal Investigator Email
paul.carrier@chu-limoges.fr
Contact Person Name
Paul CARRIER
Contact Person Email
paul.carrier@chu-limoges.fr
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Digestive Oncology department
Principal Investigator Name
Louis MARJARY
Principal Investigator Email
louis.marjary@chu-bordeaux.fr
Contact Person Name
Louis MARJARY
Contact Person Email
louis.marjary@chu-bordeaux.fr
Site Name
CHU Saint Eloi - Hopital Saint Eloi
Department Name
Hepato-gastro-enterology department
Principal Investigator Name
Michael BISMUTH
Principal Investigator Email
m-bismuth@chu-montpellier.fr
Contact Person Name
Michael BISMUTH
Contact Person Email
m-bismuth@chu-montpellier.fr

Germany

Earliest CTIS Part Ii Submission Date
24-03-2026
Latest Decision Or Authorization Date
21-04-2026
Processing Time Days
28
Number Of Sites
4
Number Of Participants
3

Sites

Site Name
Medical Center - University Of Freiburg
Department Name
Studienambulanz Rheumatologie
Principal Investigator Name
Stephanie Finzel
Principal Investigator Email
stephanie.finzel@uniklinik-freiburg.de
Contact Person Name
Stephanie Finzel
Site Name
Eugastro GmbH
Department 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
Universitaetsklinikum Heidelberg AöR
Department Name
Medizinische Klinik
Principal Investigator Name
Uta Merle
Principal Investigator Email
uta.merle@med.uni-heidelberg.de
Contact Person Name
Uta Merle
Site Name
ze:ro Praxen MVZ fuer Innere Medizin GmbH
Department Name
Ze:ro Praxen MVZ der Metropolregion GmbH & Co. eGbR
Principal Investigator Name
Manuel Zink
Principal Investigator Email
manuel.zink@zero-praxen.de
Contact Person Name
Manuel Zink
Contact Person Email
manuel.zink@zero-praxen.de

Ireland

Earliest CTIS Part Ii Submission Date
07-04-2026
Latest Decision Or Authorization Date
24-04-2026
Processing Time Days
17
Number Of Sites
3
Number Of Participants
4

Sites

Site Name
Beaumont Hospital
Department Name
Gastroenterology and Hepatology
Principal Investigator Name
John Ryan
Principal Investigator Email
johnryan2@beaumont.ie
Contact Person Name
John Ryan
Contact Person Email
johnryan2@beaumont.ie
Site Name
Cork University Hospital
Department Name
hepatology
Principal Investigator Name
Orla Crosbie
Principal Investigator Email
Orla.crosbie@hse.ie
Contact Person Name
Orla Crosbie
Contact Person Email
Orla.crosbie@hse.ie
Site Name
Connolly Hospital
Department Name
Gastroenterologist
Principal Investigator Name
Karl Hazel
Principal Investigator Email
karl.hazel@hse.ie
Contact Person Name
Karl Hazel
Contact Person Email
karl.hazel@hse.ie

Italy

Earliest CTIS Part Ii Submission Date
05-02-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
81
Number Of Sites
6
Number Of Participants
6

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
: U.O. Medicina Interna e Malattie Metaboliche
Principal Investigator Name
Anna Ludovica Fracanzani
Principal Investigator Email
anna.fracanzani@policlinico.mi.it
Contact Person Name
Anna Ludovica Fracanzani
Site Name
Azienda Sanitaria Locale Br
Department Name
U.O.C. Ematologia e Trapianto
Principal Investigator Name
Annamaria Pasanisi
Principal Investigator Email
pasanisi.am@gmail.com
Contact Person Name
Annamaria Pasanisi
Contact Person Email
pasanisi.am@gmail.com
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
SSD Malattie Rare
Principal Investigator Name
Raffaella Mariani
Principal Investigator Email
raffaella.mariani@irccs-sangerardo.it
Contact Person Name
Raffaella Mariani
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
S.C. Medicina Interna
Principal Investigator Name
Elena Corradini
Principal Investigator Email
elena.corradini75@unimore.it
Contact Person Name
Elena Corradini
Contact Person Email
elena.corradini75@unimore.it
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
U.O.S.D. Malattie Rare del Globulo Rosso Dipartimento Onco-ematologico e Pneumo-toracico
Principal Investigator Name
Paolo Ricchi
Principal Investigator Email
paolo.ricchi@aocardarelli.it
Contact Person Name
Paolo Ricchi
Contact Person Email
paolo.ricchi@aocardarelli.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
Policlinico GB Rossi di Borgo Roma
Principal Investigator Name
Domenico Girelli
Principal Investigator Email
domenico.girelli@aovr.veneto.it
Contact Person Name
Domenico Girelli

Romania

Earliest CTIS Part Ii Submission Date
09-03-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
49
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Department Name
Sectia Oncologie Medicala Compartiment Hematologie
Principal Investigator Name
Ruxandra-Maria IRIMIA
Principal Investigator Email
ruxandramariairimia@gmail.com
Contact Person Name
Ruxandra-Maria IRIMIA
Contact Person Email
ruxandramariairimia@gmail.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Sectia Hematologie
Principal Investigator Name
Ioana-Codruta RUS
Principal Investigator Email
codruta_21@yahoo.com
Contact Person Name
Ioana-Codruta RUS
Contact Person Email
codruta_21@yahoo.com
Site Name
Spitalul Clinic Judetean de Urgenta Bistrita
Department Name
Sectia Oncologie Medicala
Principal Investigator Name
Sabina-Ioana-Doinita ILUTA
Principal Investigator Email
iluta.sabina@yahoo.com
Contact Person Name
Sabina-Ioana-Doinita ILUTA
Contact Person Email
iluta.sabina@yahoo.com
Site Name
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Department Name
Sectia Clinica Medicina Interna
Principal Investigator Name
Corina-Ionela RADU
Principal Investigator Email
drcorinaradu@gmail.com
Contact Person Name
Corina-Ionela RADU
Contact Person Email
drcorinaradu@gmail.com
Site Name
Spitalul Clinic Coltea
Department Name
Clinica de Hematologie
Principal Investigator Name
Gabriela BORSARU
Principal Investigator Email
gabriex2001@yahoo.it
Contact Person Name
Gabriela BORSARU
Contact Person Email
gabriex2001@yahoo.it

Spain

Earliest CTIS Part Ii Submission Date
27-02-2026
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
59
Number Of Sites
7
Number Of Participants
7

Sites

Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
Haematology and Haemotherapy
Principal Investigator Name
Silvia de la Iglesia Iñigo
Principal Investigator Email
siglini@gmail.com
Contact Person Name
Silvia de la Iglesia Iñigo
Contact Person Email
siglini@gmail.com
Site Name
Institut Catala D'oncologia
Department Name
Haematology
Principal Investigator Name
Ines Hernández Rodríguez
Principal Investigator Email
uicico_badalona@iconcologia.net
Contact Person Name
Ines Hernández Rodríguez
Site Name
Hospital Universitario La Paz
Department Name
Haematology and Haemotherapy
Principal Investigator Name
Ana Mendoza Martinez
Principal Investigator Email
amendozam.externo@salud.madrid.org
Contact Person Name
Ana Mendoza Martinez
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Gastroenterology and Hepatolgy
Principal Investigator Name
José Luis Calleja Panero
Principal Investigator Email
jlcpan@terra.es
Contact Person Name
José Luis Calleja Panero
Contact Person Email
jlcpan@terra.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Haematology and Haemotherapy
Principal Investigator Name
Salvador Payán Pernía
Principal Investigator Email
sppayan@gmail.com
Contact Person Name
Salvador Payán Pernía
Contact Person Email
sppayan@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Blood Bank and Transfusion Service BST- Clinic
Principal Investigator Name
Cristina Chantal Sanz Marcelo
Principal Investigator Email
csanz@clinic.cat
Contact Person Name
Cristina Chantal Sanz Marcelo
Contact Person Email
csanz@clinic.cat
Site Name
Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
Department Name
Haematology and Haemotherapy
Principal Investigator Name
Albert Altes Hernández
Principal Investigator Email
aaltesh@althaia.cat
Contact Person Name
Albert Altes Hernández
Contact Person Email
aaltesh@althaia.cat

Sponsor

Primary sponsor

Full Name
CSL Behring LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD (and related PPD entities)
Responsibilities
Operational trial management including clinical chemistry/hematology labs, site payments, site contracting, data handling, endpoint testing
Name
Fisher Clinical Services Inc.
Responsibilities
Operational support (role code 14)
Name
Ppd Inc.
Responsibilities
Exploratory analysis, primary / surrogate endpoint test
Name
Eresearchtechnology Inc.
Responsibilities
eCOA / eDiary provision; ECG central reader (data collection and scientific read)
Name
Suvoda LLC
Responsibilities
Electronic data capture / site support
Name
Longboat Clinical Limited
Responsibilities
Study portal and training for CSLB/PPD, Investigator, site staff
Name
Medidata Solutions Inc.
Responsibilities
Clinical data platform responsibilities (role code 7)

Third parties

  • {"country":"Australia","full_name":"Resonance Health Analysis Services Pty Limited","duties_or_roles":"MRI analysis (LIC, spleen) via Ferriscan","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Clinical chemistry, hematology, serology, analytical chemistry, exploratory analysis, primary / surrogate endpoint test","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA / eDiary provision including design, device provision, data collection","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ECG central reader including provision of ECG machines, data collection and scientific read of the results","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel expenses / reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom","full_name":"PPD (UK) Limited","duties_or_roles":"Site Payments, Site contracting; multiple operational tasks (codes 1-12 listed)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"Role code 14 (unspecified in listing)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"Exploratory analysis, primary / surrogate endpoint test","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Study portal used for study training for CSLB/PPD, Investigator, site staff","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"Electronic data capture / site support (code 3)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Role code 7 (unspecified in listing)","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Australia","full_name":"CSL Innovation Pty Limited","duties_or_roles":"Measurement of exploratory biomarkers","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
CSL624
Active Substance
VAMIFEPORT TRIHYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus=1)
Dose Levels
Low dose | High dose
Frequency
BID (twice daily)
Investigational Product Name
Capsule (placebo matching vamifeport)
Modality
Other
Frequency
BID (twice daily)

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