Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

254

Participants

Timeline

Start Date

July 8, 2020

Primary Completion Date

June 26, 2026

Study Completion Date

July 26, 2026

Conditions
Biliary Atresia
Interventions
DRUG

Odevixibat

Odevixibat is a small molecule and selective inhibitor of IBAT.

DRUG

Placebo

Placebo identical in appearance to experimental drug (odevixibat).

Trial Locations (66)

3052

Royal Children's Hospital, Parkville

10016

NYU Grossman school of Medicine, New York

10029

Icahn School of Medicine at Mount Sinai, New York

10032

NewYork-Presbyterian Morgan Stanley Children's Hospital, New York

10467

The Children's Hospital at Montefiore, The Bronx

15224

UPMC Children's Hospital of Pittsburgh, Pittsburgh

19104

The Children´s Hospital of Philadelphia, Philadelphia

19803

Nemours/Alfred I. duPont Hospital for Children, Wilmington

20010

Children's National Medical Center, Washington D.C.

21287

Johns Hopkins Children's Center, Baltimore

30322

Children's Healthcare of Atlanta - Emory University School of Medicine, Atlanta

33146

University of Miami, Miami

44195

Cleveland Clinic, Cleveland

45229

Cincinnati Children's Hospital, Cincinnati

46202

Indiana University school of Medicine, Indianapolis

48109

University of Michigan Children's Hospital, Ann Arbor

53226

Medical College of Wisconsin, Milwaukee

60611

Ann & Robert H. Lurie Children's Hospital, Chicago

63110

Washington University in St. Louis, St Louis

64108

Children's Mercy Hospital, Kansas City

75390

UT Southwestern Medical Center, Dallas

80045

Children's Hospital Colorado, Aurora

84113

University of Utah, Salt Lake City

90027

Children's Hospital Los Angeles, Los Angeles

92123

Rady Children's Hospital, San Diego

94158

UCSF Benioff Children's Hospital San Francisco, San Francisco

94304

Stanford Children's Health, Palo Alto

97239

Oregon Health & Science University, Portland

98105

Seattle Children's Hospital, Seattle

02115

Boston Children's Hospital, Boston

Unknown

The Children´s Hospital at Westmead, Sydney

UZ Gent, Ghent

CHU Sainte-Justine, Montreal

The Hospital for Sick Children, Toronto

Guangzhou Women and Children's Medical Center, Guangzhou

Children's Hospital of Fudan University, Shanghai

Hôpital Femme Mère Enfant, Bron

Bicêtre Hospital, Le Kremlin-Bicêtre

Jeanne de Flandre Hospital, Lille

Necker University Hospital - Enfants malades, Paris

Charité - Universitätsmedizin Berlin, Berlin

University Medical Center Hamburg-Eppendorf UKE, Hamburg

Hannover Medical School, Hanover

University Children´s Hospital Tuebingen, Tübingen

Semmelweis Egyetem I.sz Gyermekgyógyászati Klinika, Budapest

Schneider Children´s Medical Center of Israel, Petah Tikva

ASST Papa Giovanni XXIII, Bergamo

Meyer Children´s University Hospital, Florence

University Hospital of Padova, Padua

ISMETT - Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione, Palermo

Ospedale Pediatrico Bambino Gesù, Roma

Regina Margherita Children´s Hospital, Turin

Hospital Raja Perempuan Zainab II, Kota Bharu

University of Malaya Medical Centre, Kuala Lumpur

University Medical Center Groningen, Groningen

Starship Child Health, Auckland

Instytut Pomnik-Centrum Zdrowia Dziecka, Warsaw

Samsung Medical Center, Seoul

Seoul National University Children's Hospital, Seoul

Hospital Universitari Vall d'Hebron, Barcelona

National Taiwan University Hospital, Taipei

Hacettepe University Ihsan Dogramaci Childrens Hospital, Ankara

Akdeniz University Medical Faculty, Antalya

Istanbul University, Istanbul Medical Faculty, Istanbul

Birmingham Women´s and Children´s Hospital, Birmingham

Leeds General Infirmary, Leeds

All Listed Sponsors
lead

Albireo, an Ipsen Company

INDUSTRY