Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
A Phase 4, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Pharmacokinetics and Safety of Obeticholic Acid in Patients With Primary Biliary Cholangitis and Moderate to Severe Hepatic Impairment
Sponsor: Intercept Pharmaceuticals
Terminated
Due to Ocaliva (obeticholic acid) US labeling update, the sponsor decided to terminate the study.
Listed as NCT03633227, this PHASE4 trial focuses on Liver Cirrhosis, Biliary and remains terminated or withdrawn. Sponsored by Intercept Pharmaceuticals, it has been updated 25 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
25 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE4
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Sep 2025 — Present [monthly]
Terminated PHASE4
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Sep 2024 — Sep 2025 [monthly]
Terminated PHASE4
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Jul 2024 — Sep 2024 [monthly]
Terminated PHASE4
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Sep 2022 — Jul 2024 [monthly]
Terminated PHASE4
▶ Show 20 earlier versions
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Dec 2021 — Sep 2022 [monthly]
Terminated PHASE4
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Sep 2021 — Dec 2021 [monthly]
Terminated PHASE4
Status: Active Not Recruiting → Terminated
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Jun 2021 — Sep 2021 [monthly]
Active Not Recruiting PHASE4
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Feb 2021 — Jun 2021 [monthly]
Active Not Recruiting PHASE4
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Jan 2021 — Feb 2021 [monthly]
Active Not Recruiting PHASE4
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Nov 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE4
Status: Recruiting → Active Not Recruiting
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Jul 2020 — Nov 2020 [monthly]
Recruiting PHASE4
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Jun 2020 — Jul 2020 [monthly]
Recruiting PHASE4
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Apr 2020 — Jun 2020 [monthly]
Recruiting PHASE4
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Mar 2020 — Apr 2020 [monthly]
Recruiting PHASE4
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Feb 2020 — Mar 2020 [monthly]
Recruiting PHASE4
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Jan 2020 — Feb 2020 [monthly]
Recruiting PHASE4
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Dec 2019 — Jan 2020 [monthly]
Recruiting PHASE4
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Oct 2019 — Dec 2019 [monthly]
Recruiting PHASE4
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Sep 2019 — Oct 2019 [monthly]
Recruiting PHASE4
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Aug 2019 — Sep 2019 [monthly]
Recruiting PHASE4
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Jun 2019 — Aug 2019 [monthly]
Recruiting PHASE4
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May 2019 — Jun 2019 [monthly]
Recruiting PHASE4
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Mar 2019 — May 2019 [monthly]
Recruiting PHASE4
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Sep 2018 — Mar 2019 [monthly]
Recruiting PHASE4
First recorded
Jun 2018
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Intercept Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .