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NCT02177136 · ClinicalTrials.gov registry record · Phase 2
Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
A Phase 2 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT02177136 is a Phase 2 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 77 participants.
The verdict
NCT02177136, a Phase 2 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study Summary
This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase; and, safety. The long-term safety extension (LTSE) phase was conducted to evaluate the safety, tolerability, and efficacy of long-term, open-label use of OCA in participants with PSC who had completed the DB phase of the study.
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid (OCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2015-02-09 |
| Est. Completion | 2018-03-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02177136
The ClinicalTrials.gov registry entry for NCT02177136 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 77 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.
NCT02177136 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02177136 about?
NCT02177136 is a clinical study titled "Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)". This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase; and, safety. The long-term safety extension (LTSE) phase was conducted to e...
What is the current status of trial NCT02177136?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2015-02-09. Estimated completion is 2018-03-22.
What interventions are being tested in trial NCT02177136?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (OCA) (DRUG).
Who is sponsoring clinical trial NCT02177136?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
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