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NCT02308111 · ClinicalTrials.gov registry record · Phase 4
Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis
A Phase 4 study, sponsored by Intercept Pharmaceuticals.
- Terminated
- Registry status
- Phase 4
- Development phase
- 334
- Enrollment target
NCT02308111: Clinical Trial Phase 4 study, sponsored by Intercept Pharmaceuticals.
NCT02308111 is a Phase 4 study that was terminated before completion, run by Intercept Pharmaceuticals. The registered enrollment target is 334 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02308111, a Phase 4 study, was terminated before completion, sponsored by Intercept Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 334 participants
- Enrollment target
Study Summary
Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (OCA) is a modified bile acid and FXR agonist that is derived from the primary human bile acid chenodeoxycholic acid. The key mechanisms of action of OCA, including its choleretic, anti-inflammatory, and anti-fibrotic properties, underlie its hepatoprotective effects and result in attenuation of injury and improved liver function in a cholestatic liver disease such as PBC. The study will assess the effect of OCA compared to placebo, combined with stable standard care, on clinical outcomes in PBC participants.
Primary Outcome
To assess the effect of OCA, compared to placebo in conjunction with the established local standard of care, on clinical outcomes in participants with PBC as measured by time to the first occurrence of any of the following adjudicated events, derived as a composite event endpoint of death, liver transplant, model of end-stage liver disease (MELD) ≥15, uncontrolled ascites, or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy (as defined by a West Haven score o
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid (OCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 334 participants |
| Start Date | 2014-12-26 |
| Est. Completion | 2021-12-23 |
| Phase | Phase 4 |
Why NCT02308111 stopped before completion
NCT02308111 is an interventional study that assigns participants to a tested intervention. The registered 334 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (36% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02308111 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02308111 about?
NCT02308111 is a clinical study titled "Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis". Primary Biliary Cholangitis (PBC) is a serious, life-threatening, bile acid related liver disease of unknown cause. Without treatment, it frequently progresses to liver fibrosis and eventual cirrhosis requiring liver transplantation or resulting in death. The investigational drug, Obeticholic Acid (...
What is the current status of trial NCT02308111?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 334 participants. The study started on 2014-12-26. Estimated completion is 2021-12-23.
What interventions are being tested in trial NCT02308111?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (OCA) (DRUG).
Who is sponsoring clinical trial NCT02308111?
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 NCT02308111's enrollment target sits among peer trials
334 252nd of 2000 higher than 1,749 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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