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NCT03633227 · ClinicalTrials.gov registry record · Phase 4
Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment
A Phase 4 study, sponsored by Intercept Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT03633227: Clinical Trial Phase 4 study, sponsored by Intercept Pharmaceuticals.
NCT03633227 is a Phase 4 study that was terminated before completion, run by Intercept Pharmaceuticals. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03633227, a Phase 4 study, was terminated before completion, sponsored by Intercept Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatment period will continue double-blind treatment until all randomized participants have completed their 48-week treatment period and the database for that period is locked. An open-label extension study in which all participants receive OCA will be considered following review of blinded safety and PK data.
Primary Outcome
Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. Pharmacokinetics (PK) of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid (OCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-06-22 |
| Est. Completion | 2021-07-09 |
| Phase | Phase 4 |
Why NCT03633227 stopped before completion
NCT03633227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03633227 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03633227 about?
NCT03633227 is a clinical study titled "Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment". This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatmen...
What is the current status of trial NCT03633227?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2018-06-22. Estimated completion is 2021-07-09.
What interventions are being tested in trial NCT03633227?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (OCA) (DRUG).
Who is sponsoring clinical trial NCT03633227?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03633227's enrollment target sits among peer trials
22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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