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NCT00570765 · ClinicalTrials.gov registry record · Phase 2
Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)
A Phase 2 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00570765 is a Phase 2 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 60 participants.
The verdict
NCT00570765, a Phase 2 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid (OCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2008-01-17 |
| Est. Completion | 2017-09-25 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00570765
The ClinicalTrials.gov registry entry for NCT00570765 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 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.
NCT00570765 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00570765 about?
NCT00570765 is a clinical study titled "Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)". The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.
What is the current status of trial NCT00570765?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2008-01-17. Estimated completion is 2017-09-25.
What interventions are being tested in trial NCT00570765?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (OCA) (DRUG).
Who is sponsoring clinical trial NCT00570765?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
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