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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 is a Phase 4 study that was terminated before completion, run by Intercept Pharmaceuticals. The registered enrollment target is 334 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02308111
The ClinicalTrials.gov registry entry for NCT02308111 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 334 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intercept Pharmaceuticals, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02308111 reports 0 study locations.
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.
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