TerminatedNCT06121375Updated Jul 7, 2026Results posted

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

A Phase 2/3 interventional study of OCA and Matching Placebo in Biliary Atresia, sponsored by Intercept Pharmaceuticals. Terminated at 24 sites in 10 countries. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Intercept Pharmaceuticals · Phase 2/3, Interventional, and Treatment

Why this study was terminated

Intercept made a business decision to terminate the study based on FDA's request for voluntary withdrawal of Ocaliva and the issuance of clinical hold on studies under US IND involving OCA.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 28
Allocation: Randomized
Ages: 1 Day to 18 Years
Sex: All

Study summary

This study will evaluate the efficacy, safety and tolerability, as well as PK/PD of OCA in eligible pediatric participants with biliary atresia with successful hepatoportoenterostomy (HPE, also known as a Kasai portoenterostomy). The double-blind period comprises of 2 phases: dose titration phase and age expansion treatment phase.

Conditions studied

Biliary Atresia

Browse trials for

Biliary Atresia 75

Keywords

Biliary Atresia
Placebo-controlled
Pharmacokinetics
Pharmacodynamics
Obeticholic Acid
Efficacy
Post-hepatoportoenterostomy

In context

Biliary Atresia

75 studies on the registry are indexed under Biliary Atresia; 25 are open to participants now.

This study's enrollment of 28 is below the median of 43 across 42 interventional studies indexed under Biliary Atresia.

Browse Biliary Atresia studies →

Lead sponsor

Intercept Pharmaceuticals is the lead sponsor of 21 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Day to 18 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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).

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Care provider)
Enrollment: 28 participants (actual)

Study arms

Active comparator
Participants receiving OCA
Participants will be randomized to receive OCA (starting at 1.5 milligrams \[mg\] adult equivalent dose \[AED\]) orally, with water, once daily. Dose will be titrated every 2 weeks in a stepwise manner for the first 6 weeks, starting at 1.5 mg AED and titrating through 3 mg AED to a maximum of 5 mg AED, as tolerated; a discussion with the Medical Monitor is encouraged when determining uptitration if considerable signs or symptoms have arisen. Following the 6-week dose titration phase, participants will continue at the tolerated dose for approximately 24 months in Age Expansion Treatment Phase.
Drug: OCA
Placebo comparator
Participants receiving Matching placebo
Participants will be randomized to receive matching placebo orally, with water, once daily. Dose will be titrated every 2 weeks in a stepwise manner for the first 6 weeks, starting at 1.5 mg AED and titrating through 3 mg AED to a maximum of 5 mg AED, as tolerated; a discussion with the Medical Monitor is encouraged when determining uptitration if considerable signs or symptoms have arisen. Following the 6-week dose titration phase, participants will continue at the tolerated dose for approximately 24 months in Age Expansion Treatment Phase.
Drug: Matching Placebo

Interventions

DrugOCA
OCA will be administered.
DrugMatching Placebo
Matching Placebo will be administered.

What researchers measure

Primary outcomes

Number of Participants With Composite Liver-Related Clinical Events
Number of participants experiencing any of the following: All-cause death; Liver transplantation; Hospitalization (≥24 hours) for variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis; Clinically relevant ascites requiring therapeutic paracentesis have been presented. No clinical outcome events were reported at the time of the study termination; hence It was not possible to conduct the planned primary efficacy analysis.
Time frame: Up to Week 48
Change From Baseline in Pediatric End-stage Liver Disease (PELD) Score
The Pediatric End-stage Liver Disease (PELD) score is a scale used to assess the severity of chronic liver disease in pediatric participants younger than 12 years of age. The total PELD score ranges from negative values to positive values, with no absolute minimum or maximum, with higher scores indicating more severe liver disease and greater urgency for liver transplantation. The score is calculated using total bilirubin, international normalized ratio (INR), albumin, age at listing, and growth failure. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was calculated as the last post-baseline value minus the baseline value. A negative change from baseline indicates improvement, while a positive change indicates worsening.
Time frame: Baseline and up to Week 48
Change From Baseline in Model of End-stage Liver Disease With Sodium (MELD-NA) Score
The Model of End-stage Liver Disease with Sodium (MELD-Na) score is a scale used to assess the severity of chronic liver disease in participants 12 years of age and older, ranging from 6 (less ill) to 40 (gravely ill). Higher scores indicate more severe liver disease and greater urgency for liver transplantation. The score is derived from total bilirubin, serum creatinine, INR, and serum sodium. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was calculated as the last post-baseline value minus the baseline value. A negative change from baseline indicates improvement, while a positive change indicates worsening.
Time frame: Baseline and up to Week 48

Secondary outcomes

Percentage of Participants With Improvement in GGT and Direct Bilirubin (Composite Responder Endpoint)
Participants were considered responders if both of the following criteria were met at EOS: ≥40% reduction from baseline in Gamma Glutamyl Transferase (GGT), and ≥25% reduction from baseline in direct (conjugated) bilirubin. Participants with missing values were considered non-responders.
Time frame: Up to Week 48
Change From Baseline in GGT
Blood samples were collected to assess GGT levels. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.
Time frame: Baseline and up to Week 48
Change From Baseline in Total and Direct (Conjugated) Bilirubin
Blood samples were collected to assess direct bilirubin levels. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.
Time frame: Baseline and up to Week 48
Change From Baseline in Endogenous Bile Acids
Plasma samples were collected to assess endogenous bile acids. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.
Time frame: Baseline and up to Week 48
Change From Baseline in Liver Stiffness as Assessed by Transient Elastography
Liver stiffness was measured using ultrasound elastography. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.
Time frame: Baseline and up to Week 48
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
TEAEs were defined as adverse events that were reported or worsened on or after the first dose of study treatment. Serious adverse events are adverse events resulting in death, are immediately life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity.
Time frame: Up to Week 48
Change From Baseline in Plasma Levels of Fat-Soluble Vitamin D
Plasma samples were collected to assess levels of fat-soluble vitamins D. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.
Time frame: Baseline and Week 48
Change From Baseline in Plasma Levels of Fat-Soluble Vitamin K
Plasma samples were collected to assess levels of fat-soluble vitamin K. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.
Time frame: Baseline and Week 48

Results

Posted Jul 7, 2026

Participant flow

This was a global, multicenter, double-blind, placebo-controlled study that evaluated efficacy, safety, and tolerability as well as pharmacokinetic/pharmacodynamic of Obeticholic Acid (OCA) in pediatric participants with biliary atresia with successful Hepatoportoenterostomy (HPE).

Dose Titration Phase (Up to 6 Weeks)

Participant flow — Dose Titration Phase (Up to 6 Weeks)
Milestone	Obeticholic Acid	Placebo
Started	14	14
Completed	11	12
Not completed	3	2
Withdrew: Sponsor decision	2	2
Withdrew: Withdrawal by subject	1	0

Age Expansion Phase (Up to 24 Months)

Participant flow — Age Expansion Phase (Up to 24 Months)
Milestone	Obeticholic Acid	Placebo
Started	11	12
Completed	0	0
Not completed	11	12
Withdrew: Sponsor decision	11	11
Withdrew: Investigator's decision	0	1

Outcome measures

PrimaryNumber of Participants With Composite Liver-Related Clinical Events

Number of participants experiencing any of the following: All-cause death; Liver transplantation; Hospitalization (≥24 hours) for variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis; Clinically relevant ascites requiring therapeutic paracentesis have been presented. No clinical outcome events were reported at the time of the study termination; hence It was not possible to conduct the planned primary efficacy analysis.

Time frame:: Up to Week 48
Reported as:: Count of participants · Participants

Number of Participants With Composite Liver-Related Clinical Events
Participants	Obeticholic Acid (OCA)	Placebo
Number of Participants With Composite Liver-Related Clinical Events	0	0

PrimaryChange From Baseline in Pediatric End-stage Liver Disease (PELD) Score

The Pediatric End-stage Liver Disease (PELD) score is a scale used to assess the severity of chronic liver disease in pediatric participants younger than 12 years of age. The total PELD score ranges from negative values to positive values, with no absolute minimum or maximum, with higher scores indicating more severe liver disease and greater urgency for liver transplantation. The score is calculated using total bilirubin, international normalized ratio (INR), albumin, age at listing, and growth failure. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was calculated as the last post-baseline value minus the baseline value. A negative change from baseline indicates improvement, while a positive change indicates worsening.

Time frame:: Baseline and up to Week 48
Reported as:: Mean · score on a scale

Change From Baseline in Pediatric End-stage Liver Disease (PELD) Score
score on a scale	Obeticholic Acid (OCA)	Placebo
Change From Baseline in Pediatric End-stage Liver Disease (PELD) Score	0.8 ± 2.56	0.8 ± 3.10

PrimaryChange From Baseline in Model of End-stage Liver Disease With Sodium (MELD-NA) Score

The Model of End-stage Liver Disease with Sodium (MELD-Na) score is a scale used to assess the severity of chronic liver disease in participants 12 years of age and older, ranging from 6 (less ill) to 40 (gravely ill). Higher scores indicate more severe liver disease and greater urgency for liver transplantation. The score is derived from total bilirubin, serum creatinine, INR, and serum sodium. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was calculated as the last post-baseline value minus the baseline value. A negative change from baseline indicates improvement, while a positive change indicates worsening.

Time frame:: Baseline and up to Week 48
Reported as:: Mean · score on a scale

Change From Baseline in Model of End-stage Liver Disease With Sodium (MELD-NA) Score
score on a scale	Obeticholic Acid (OCA)	Placebo
Change From Baseline in Model of End-stage Liver Disease With Sodium (MELD-NA) Score	0.0 ± 0.00	-0.3 ± 0.29

SecondaryPercentage of Participants With Improvement in GGT and Direct Bilirubin (Composite Responder Endpoint)

Participants were considered responders if both of the following criteria were met at EOS: ≥40% reduction from baseline in Gamma Glutamyl Transferase (GGT), and ≥25% reduction from baseline in direct (conjugated) bilirubin. Participants with missing values were considered non-responders.

Time frame:: Up to Week 48
Reported as:: Number · percentage of participants

Percentage of Participants With Improvement in GGT and Direct Bilirubin (Composite Responder Endpoint)
percentage of participants	Obeticholic Acid (OCA)	Placebo
Percentage of Participants With Improvement in GGT and Direct Bilirubin (Composite Responder Endpoint)	0	0

SecondaryChange From Baseline in GGT

Blood samples were collected to assess GGT levels. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.

Time frame:: Baseline and up to Week 48
Reported as:: Mean · Units/liter (U/L)

Change From Baseline in GGT
Units/liter (U/L)	Obeticholic Acid (OCA)	Placebo
Change From Baseline in GGT	3.6 ± 28.30	-7.8 ± 25.28

SecondaryChange From Baseline in Total and Direct (Conjugated) Bilirubin

Blood samples were collected to assess direct bilirubin levels. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.

Time frame:: Baseline and up to Week 48
Reported as:: Mean · micromol/liter (mcmol/L)

Change From Baseline in Total and Direct (Conjugated) Bilirubin
micromol/liter (mcmol/L)	Obeticholic Acid (OCA)	Placebo
Total Bilirubin	-1.0 ± 1.92	-0.6 ± 3.18
Direct Bilirubin	-1.2 ± 0.69	-1.1 ± 1.36

SecondaryChange From Baseline in Endogenous Bile Acids

Plasma samples were collected to assess endogenous bile acids. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.

Time frame:: Baseline and up to Week 48
Reported as:: Mean · micromol/liter (mcmol/L)

Change From Baseline in Endogenous Bile Acids
micromol/liter (mcmol/L)	Obeticholic Acid (OCA)	Placebo
Change From Baseline in Endogenous Bile Acids	-8.4 ± 19.70	-9.7 ± 15.72

SecondaryChange From Baseline in Liver Stiffness as Assessed by Transient Elastography

Liver stiffness was measured using ultrasound elastography. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.

Time frame:: Baseline and up to Week 48
Reported as:: Mean · kilopascals (kPa)

Change From Baseline in Liver Stiffness as Assessed by Transient Elastography
kilopascals (kPa)	Obeticholic Acid (OCA)	Placebo
Change From Baseline in Liver Stiffness as Assessed by Transient Elastography	-1.0 ± 3.93	0.6 ± 4.03

SecondaryNumber of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs

TEAEs were defined as adverse events that were reported or worsened on or after the first dose of study treatment. Serious adverse events are adverse events resulting in death, are immediately life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, or results in persistent or significant disability/incapacity.

Time frame:: Up to Week 48
Reported as:: Count of participants · Participants

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
Participants	Obeticholic Acid (OCA)	Placebo
Any TEAE	13	11
Any Serious TEAE	3	0

SecondaryChange From Baseline in Plasma Levels of Fat-Soluble Vitamin D

Plasma samples were collected to assess levels of fat-soluble vitamins D. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.

Time frame:: Baseline and Week 48
Reported as:: Mean · nanomoles/L (nmol/L)

Change From Baseline in Plasma Levels of Fat-Soluble Vitamin D
nanomoles/L (nmol/L)	Obeticholic Acid (OCA)	Placebo
Change From Baseline in Plasma Levels of Fat-Soluble Vitamin D	8.1 ± 14.85	15.8 ± 23.95

SecondaryChange From Baseline in Plasma Levels of Fat-Soluble Vitamin K

Plasma samples were collected to assess levels of fat-soluble vitamin K. Baseline was defined as the last assessment prior to first study drug administration. Change from baseline was computed by subtracting the baseline value from the post-baseline value, with a positive change indicating improvement.

Time frame:: Baseline and Week 48
Reported as:: Mean · nanograms/millilitres (ng/mL)

Change From Baseline in Plasma Levels of Fat-Soluble Vitamin K
nanograms/millilitres (ng/mL)	Obeticholic Acid (OCA)	Placebo
Change From Baseline in Plasma Levels of Fat-Soluble Vitamin K	0.1 ± 0.40	0.1 ± 1.43

Adverse events

Collected over Up to Week 48. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Obeticholic Acid (OCA)	0/14 (0%)	3/14 (21.4%)	13/14 (92.9%)
Placebo	0/14 (0%)	0/14 (0%)	11/14 (78.6%)

Most frequent serious events

Most frequent serious events
Event	Obeticholic Acid (OCA)	Placebo
Infected aural fistulaInfections and infestations	1/14	0/14
PneumoniaInfections and infestations	1/14	0/14
Rhinovirus infectionInfections and infestations	1/14	0/14

Most frequent other events

Showing 10 of 60

Most frequent other events
Event	Obeticholic Acid (OCA)	Placebo
Upper respiratory tract infectionInfections and infestations	3/14	5/14
DiarrhoeaGastrointestinal disorders	1/14	4/14
Alanine aminotransferase increasedInvestigations	4/14	1/14
Gamma-glutamyltransferase increasedInvestigations	4/14	1/14
NasopharyngitisInfections and infestations	2/14	1/14
Viral upper respiratory tract infectionInfections and infestations	1/14	2/14
GastroenteritisInfections and infestations	0/14	2/14
Viral infectionInfections and infestations	0/14	2/14
Abdominal painGastrointestinal disorders	2/14	2/14
ConstipationGastrointestinal disorders	1/14	2/14

Baseline characteristics

The intent-to-treat (ITT) Population included all randomized participants.

Age, Continuous
Age, Continuous(years)	Obeticholic Acid (OCA)	Placebo	Total
Mean	7.4 ± 4.31	8.6 ± 5.17	8.0 ± 4.71

Sex: Female, Male
Sex: Female, Male(Participants)	Obeticholic Acid (OCA)	Placebo	Total
Female	5	6	11
Male	9	8	17

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Obeticholic Acid (OCA)	Placebo	Total
Hispanic or Latino	0	0	0
Not Hispanic or Latino	14	14	28
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Obeticholic Acid (OCA)	Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	10	10	20
Native Hawaiian or Other Pacific Islander	2	0	2
Black or African American	0	0	0
White	1	2	3
More than one race	0	0	0
Unknown or Not Reported	1	2	3

Study locations

24 sites

Queensland Childrens Hospital
South Brisbane, Queensland 4101, Australia
Women's and Children's Hospital
North Adelaide, South Australia 5006, Australia
Royal Childrens Hospital
Parkville, Victoria 3104, Australia
Alberta Childrens Hospital
Calgary, Alberta T3B 6A8, Canada
Stollery Children's Hospital
Edmonton, Alberta, Canada
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310006, China
Guangzhou Women And Childrens Medical Center
Guangzhou, China
Children's Hospital of Fudan University
Shanghai, China
Childrens Hospital of Shanghai
Shanghai, China
Children's Hospital of Shanxi
Taiyuan, China
Queen Mary Hospital
Hong Kong, Hong Kong
Hadassah Medical Center
Jerusalem, Israel
Shaare-Zedek Medical Center
Jerusalem, Israel
Hospital Raja Perempuan Azinab II
Kota Bharu, Kelantan 15586, Malaysia
University Malaya Medical Center
Kuala Lumpur, 59100, Malaysia
Starship Child Health
Auckland, 1142, New Zealand
KK Women's and Children's Hospital
Singapore, Singapore
Taichung Veterans General Hospital
Taichung, Taiwan
National Chen Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, Taiwan
Akdeniz Üniversitesi Tıp Fakültesi Hastanesi Pediatrik Gastroenteroloji
Konyaalti, Antalya 07050, Turkey (Türkiye)
Ege Üniversitesi Hastanesi Pediatrik Gastroenteroloji Bölümü
Bornova, İzmir 35100, Turkey (Türkiye)
Hacettepe Universitesi ihsan Dogramaci Cocuk Hastansesi
Ankara, 06230, Turkey (Türkiye)

References and documents

Study documents

Study protocol · Sep 14, 2023
Statistical analysis plan · Oct 21, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06121375
Lead sponsor: Intercept Pharmaceuticals
Responsible party: Sponsor
First posted: Nov 7, 2023
Start date: Sep 2, 2024
Primary completion: Oct 21, 2025
Completion: Oct 21, 2025
Results posted: Jul 7, 2026
Last update: Jul 7, 2026

Study contacts

Lynda Szczech, MD

study director · Intercept Pharmaceuticals

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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