Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
NCT03439254 · REVERSE Phase 3Completed
- Lead sponsor
- Intercept Pharmaceuticals (Industry)
- Enrollment
- 919 (actual)
- Start date
- 30 Aug 2017
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022
- Last update posted
- 23 Oct 2023
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 3
Interventions
- Obeticholic acid (10 mg) Drug
- Obeticholic acid (10 mg to 25 mg) Drug
- Placebo Drug
Conditions and primary outcome
- Compensated Cirrhosis
- Nonalcoholic Steatohepatitis
Primary outcome
DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH) (Up to 18 months); OLE Phase: Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) (Up to 12 months); OLE Phase: Change From Baseline to Month 12 in Liver Stiffness Measurement (LSM) (Baseline and up to Month 12); OLE Phase: Fibrosis-4 (FIB-4) at Baseline (Baseline (Day 1)); OLE Phase: Enhanced Liver Fibrosis (ELF) at Baseline (Baseline (Day 1)); OLE Phase: Number of Participants Reporting All-cause Mortality (Up to Month 12); OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Ascites, Hepatocellular Carcinoma (HCC) and Non-liver Related Death (Up to 12 months); OLE Phase: Number of Participants With Adjudicated Liver Related Clinical Outcomes: Worsening of Child-Pugh Score (Up to 12 months); OLE Phase: Number of Participants With Adjudicated Liver…
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT03439254 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH)
- Time frame
- Up to 18 months
- Measure
- Count of participants
- Unit
- Participants
DB: Placebo vs DB: OCA 10 Milligrams (mg)Other
- Estimate
- 1.13Response ratio(Mantel-Haenszel estimate)
- 95% CI, two-sided
- 0.71 to 1.79
- p-value
- 0.6172
- Method
- Cochran-Mantel-Haenszel
DB: Placebo vs DB: OCA 10 mg Titrated to OCA 25 mgOther
- Estimate
- 1.20Response ratio(Mantel-Haenszel estimate)
- 95% CI, two-sided
- 0.77 to 1.89
- p-value
- 0.4184
- Method
- Cochran-Mantel-Haenszel
Serious adverse events
Time frame: Up to 18 months for DB phase and Up to 1 year for OLE phase
| Group | Affected | At risk |
|---|---|---|
| DB: Placebo | 43 | 312 |
| DB: OCA 10 Milligrams (mg) | 49 | 295 |
| DB: OCA 10 mg Titrated to OCA 25 mg | 46 | 309 |
| OLE: OCA 10 mg (DB Placebo) | 26 | 231 |
| OLE: OCA 10 mg (DB OCA 10 mg) | 50 | 221 |
| OLE: Titrated to OCA 25 mg (DB OCA 10 mg Titrated to OCA 25 mg) | 48 | 207 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
No PubMed citation lists NCT03439254.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT03439254 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.