Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

September 2, 2024

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Biliary Atresia
Interventions
DRUG

OCA

OCA will be administered.

DRUG

Matching Placebo

Matching Placebo will be administered.

Trial Locations (24)

1142

Starship Child Health, Auckland

3104

Royal Childrens Hospital, Parkville

4101

Queensland Childrens Hospital, South Brisbane

5006

Women's and Children's Hospital, North Adelaide

15586

Hospital Raja Perempuan Azinab II, Kota Bharu

35100

Ege Üniversitesi Hastanesi Pediatrik Gastroenteroloji Bölümü, Bornova

59100

University Malaya Medical Center, Kuala Lumpur

310006

Children's Hospital, Zhejiang University School of Medicine, Hangzhou

T3B 6A8

Alberta Childrens Hospital, Calgary

Unknown

Stollery Children's Hospital, Edmonton

Guangzhou Women And Childrens Medical Center, Guangzhou

Children's Hospital of Fudan University, Shanghai

Childrens Hospital of Shanghai, Shanghai

Children's Hospital of Shanxi, Taiyuan

Queen Mary Hospital, Hong Kong

Hadassah Medical Center, Jerusalem

Shaare-Zedek Medical Center, Jerusalem

KK Women's and Children's Hospital, Singapore

Taichung Veterans General Hospital, Taichung

National Chen Kung University Hospital, Tainan City

National Taiwan University Hospital, Taipei

Linkou Chang Gung Memorial Hospital, Taoyuan District

07050

Akdeniz Üniversitesi Tıp Fakültesi Hastanesi Pediatrik Gastroenteroloji, Konyaalti

06230

Hacettepe Universitesi ihsan Dogramaci Cocuk Hastansesi, Ankara

Sponsors
All Listed Sponsors
lead

Intercept Pharmaceuticals

INDUSTRY