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Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis

NCT03439254 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 919

Last updated 2023-10-23

Study results available
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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.

Conditions

Interventions

DRUG

Obeticholic acid (10 mg)

Tablets administered orally once daily.

DRUG

Obeticholic acid (10 mg to 25 mg)

Tablets administered orally once daily.

DRUG

Placebo

Tablets administered orally once daily.

Sponsors & Collaborators

  • Intercept Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-30
Primary Completion
2022-09-08
Completion
2022-09-08
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Hungary
  • New Zealand
  • Poland
  • Puerto Rico
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03439254 on ClinicalTrials.gov