# Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis

> **NCT02308111** · PHASE4 · TERMINATED · sponsor: **Intercept Pharmaceuticals** · enrollment: 334 (actual)

## Conditions studied

- Liver Cirrhosis, Biliary

## Interventions

- **DRUG:** Obeticholic Acid (OCA)
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT02308111
- **Lead sponsor:** Intercept Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2014-12-26
- **Primary completion:** 2021-12-23
- **Final completion:** 2021-12-23
- **Target enrollment:** 334 (ACTUAL)
- **Why stopped:** The DMC made the recommendation to not pursue further enrollment given the lack of feasibility for this post-marketing study as designed.
- **Last updated:** 2023-03-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02308111

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02308111, "Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT02308111. Licensed CC0.

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