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NCT01473524 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
A Phase 3 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 217
- Enrollment target
NCT01473524 is a Phase 3 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 217 participants.
The verdict
NCT01473524, a Phase 3 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 217 participants
- Enrollment target
Study Summary
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid (OCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2012-01 |
| Est. Completion | 2018-12-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01473524
The ClinicalTrials.gov registry entry for NCT01473524 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 217 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.
NCT01473524 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01473524 about?
NCT01473524 is a clinical study titled "Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis". The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).
What is the current status of trial NCT01473524?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 217 participants. The study started on 2012-01. Estimated completion is 2018-12-17.
What interventions are being tested in trial NCT01473524?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (OCA) (DRUG).
Who is sponsoring clinical trial NCT01473524?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
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