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Liver drug trial for kids with biliary atresia ends early

NCT ID NCT06121375

Disease control Sponsor: Intercept Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study tested the drug obeticholic acid in children with biliary atresia who had already undergone Kasai surgery. The goal was to see if the drug could improve outcomes like avoiding liver transplant or death. The trial was terminated early and enrolled only 28 participants, so results are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
obeticholic acid
What this could lead to
If it had worked, this could have pointed toward a new treatment to delay or prevent liver transplant in children with biliary atresia.
What could go wrong
The trial was terminated early, so we don't have clear results. It was also a small study, and the drug may not have shown enough benefit or may have caused side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

28 people

The number who actually took part.

Started

Sep 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Male or female pediatric participants from birth to \<18 years old. Note: Participants aged \<2 years old will not be enrolled until after review of safety data during the planned interim analysis and agreement from the Data Safety Monitoring Board (DSMB) that there is sufficient safety data to enroll this age group. * Diagnosis of non-syndromic biliary atresia. * Demonstrated successful HPE as defined by total bilirubin \<2 milligrams per deciliter (mg/dL) (34.2 micromoles per liter \[μmol/L\]) at least 3 months post-HPE procedure. Exclusion criteria: * Prior liver transplant or active status on transplant list. * Participants diagnosed with biliary atresia splenic malformation (BASM). * Conjugated (direct) bilirubin ≥ upper limit of normal (ULN) of site-specific reference range. If conjugated bilirubin is not available: total bilirubin ≥2 mg/dL (34.2 mol/L). * Platelets \<120,000/μL * International normalized ratio (INR) ≥1.5. * Current or history of complications of decompensated chronic liver disease including: 1. Gastroesophageal varices and/or variceal bleeding 2. Clinically evident ascites related to portal hypertension 3. Hepatic encephalopathy 4. Prior placement of portosystemic shunt 5. Hepatopulmonary syndrome or portopulmonary hypertension 6. Hepatorenal syndrome 7. Any evidence of portal hypertension based on imaging (e.g., cavernous transformation of portal vein, abdominal varices, etc.) 8. Hepatocellular carcinoma 9. Childs-Pugh B or C * Height and weight Z-score \<-2 per site-specific reference ranges. * Acholic (pale) stools. * Aspartate aminotransferase (AST) \>4x ULN. * Alanine aminotransferase \>4x ULN * GGT \>500 Units per Liter (U/L) * On anticoagulation therapy * Albumin \<3.5 grams per deciliter (g/dL). * Inability to swallow tablets (i.e., tablet or mini-tablet formulations).

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Conditions

The condition(s) this trial relates to.

biliary atresia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary atresia

Contacts and locations

Locations

  • Akdeniz Üniversitesi Tıp Fakültesi Hastanesi Pediatrik Gastroenteroloji

    Konyaalti, Antalya, 07050, Turkey (Türkiye)

  • Alberta Childrens Hospital

    Calgary, Alberta, T3B 6A8, Canada

  • Children's Hospital of Fudan University

    Shanghai, China

  • Children's Hospital of Shanxi

    Taiyuan, China

  • Children's Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310006, China

  • Childrens Hospital of Shanghai

    Shanghai, China

  • Ege Üniversitesi Hastanesi Pediatrik Gastroenteroloji Bölümü

    Bornova, İzmir, 35100, Turkey (Türkiye)

  • Guangzhou Women And Childrens Medical Center

    Guangzhou, China

  • Hacettepe Universitesi ihsan Dogramaci Cocuk Hastansesi

    Ankara, 06230, Turkey (Türkiye)

  • Hadassah Medical Center

    Jerusalem, Israel

  • Hospital Raja Perempuan Azinab II

    Kota Bharu, Kelantan, 15586, Malaysia

  • KK Women's and Children's Hospital

    Singapore, Singapore

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, Taiwan

  • National Chen Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Queensland Childrens Hospital

    South Brisbane, Queensland, 4101, Australia

  • Royal Childrens Hospital

    Parkville, Victoria, 3104, Australia

  • Shaare-Zedek Medical Center

    Jerusalem, Israel

  • Starship Child Health

    Auckland, 1142, New Zealand

  • Stollery Children's Hospital

    Edmonton, Alberta, Canada

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • University Malaya Medical Center

    Kuala Lumpur, 59100, Malaysia

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.