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NCT03439254 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
A Phase 3 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 919
- Enrollment target
NCT03439254 is a Phase 3 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 919 participants.
The verdict
NCT03439254, a Phase 3 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 919 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
Interventions
- DRUG Placebo
- DRUG Obeticholic acid (10 mg)
- DRUG Obeticholic acid (10 mg to 25 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 919 participants |
| Start Date | 2017-08-30 |
| Est. Completion | 2022-09-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03439254
The ClinicalTrials.gov registry entry for NCT03439254 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 919 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 3 interventions - of which Placebo is the first listed.
NCT03439254 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03439254 about?
NCT03439254 is a clinical study titled "Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis". The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
What is the current status of trial NCT03439254?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 919 participants. The study started on 2017-08-30. Estimated completion is 2022-09-08.
What interventions are being tested in trial NCT03439254?
The interventions under investigation include: Placebo (DRUG), Obeticholic acid (10 mg) (DRUG), Obeticholic acid (10 mg to 25 mg) (DRUG).
Who is sponsoring clinical trial NCT03439254?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
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