# Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

> **NCT03633227** · PHASE4 · TERMINATED · sponsor: **Intercept Pharmaceuticals** · enrollment: 22 (actual)

## Conditions studied

- Liver Cirrhosis, Biliary

## Interventions

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

## Key facts

- **NCT ID:** NCT03633227
- **Lead sponsor:** Intercept Pharmaceuticals
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE4
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2018-06-22
- **Primary completion:** 2021-07-09
- **Final completion:** 2021-07-09
- **Target enrollment:** 22 (ACTUAL)
- **Why stopped:** Due to Ocaliva (obeticholic acid) US labeling update, the sponsor decided to terminate the study.
- **Last updated:** 2022-09-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03633227

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03633227, "Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT03633227. Licensed CC0.

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