This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2

PHASE3CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

May 16, 2018

Primary Completion Date

July 27, 2020

Study Completion Date

July 28, 2020

Conditions
PFIC1PFIC2
Interventions
DRUG

A4250 (odevixibat)

A4250 is a small molecule and selective inhibitor of ileal bile acid transporter (IBAT).

DRUG

Placebo

Placebo identical in appearance to active drug (A4250).

Trial Locations (45)

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center - Presbyterian Hospital Building, New York

11211

King Faisal Specialist Hospital & Research Centre, Riyadh

15224

Children's Hospital of Pittsburgh, Pittsburgh

19104

Children's Hospital of Philadelphia, Philadelphia

21287

Johns Hopkins School of Medicine, Baltimore

30329

Emory University School of Medicine, Atlanta

44195

Cleveland Clinic, Cleveland

63110

Washington University School of Medicine, St Louis

77030

Baylor College of Medicine - Texas Children's Liver Center, Houston

80045

Children's Hospital Colorado, Denver

90027

Children's Hospital Los Angeles, Los Angeles

94143

University of California, San Francisco, San Francisco

Unknown

The Royal Children's Hospital, Melbourne

UZ Leuven, Leuven

Cliniques Universitaires Saint-Luc, Woluwe-Saint-Lambert

The Hospital for Sick Children, Toronto

British Columbia Children's Hospital, Vancouver

University and Pediatric Hospital of Lyon, Bron

Universite Paris SUD - Hopitaux Universitaires Paris-Sud - Hopital Bicetre, Le Kremlin-Bicêtre

Hospital de la Timone, Marseille

Hospital Necker-Enfants maladies, Paris

Uniklinikum Essen- Kinderklinik II, Essen

Medizinische Hochschule Hannover, Hanover

Kinderklinik Tübingen, Universitätsklinikum Tübingen, Tübingen

Rambam Medical Centre, Haifa

Shaare-Zedek Mc, Jerusalem

Schneider Children's Medical Center Of Israel, Petah Tikva

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

University Hospital Of Padova, Padua

Ospedale Regina Margherita, Torino

University Medical Center Groningen, Groningen

Universitair Medisch Centrum (UMC) Utrecht, Utrecht

Instytut Pomnik - Centrum Zdrowia Dziecka, Warsaw

Hospital Universitari Vall d'Hebron, Barcelona

Hospital Universitario La Paz, Madrid

Astrid Lindgren Children's Hospital, Karolinska University Hospital, Solna

Gazi University, Ankara

Hacettepe University Faculty of Medicine, Ankara

Akdeniz University, Antalya

Istanbul University Medical Faculty, Istanbul

Inonu University Medical Faculty, Malatya

Birmingham Women's and Children's NHS Foundation Trust, Birmingham

Leeds General Infirmary, Leeds

Institute of Liver Studies - Kings College Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Albireo

INDUSTRY

NCT03566238 - This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2 | Biotech Hunter | Biotech Hunter