# 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

> **NCT06121375** · PHASE2,PHASE3 · TERMINATED · sponsor: **Intercept Pharmaceuticals** · enrollment: 28 (actual)

## Conditions studied

- Biliary Atresia

## Interventions

- **DRUG:** OCA
- **DRUG:** Matching Placebo

## Key facts

- **NCT ID:** NCT06121375
- **Lead sponsor:** Intercept Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2,PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2024-09-02
- **Primary completion:** 2025-10-21
- **Final completion:** 2025-10-21
- **Target enrollment:** 28 (ACTUAL)
- **Why stopped:** 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.
- **Last updated:** 2025-10-31


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06121375

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06121375, "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". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT06121375. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*