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Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

NCT02548351 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2477

Last updated 2024-10-01

Study results available
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Summary

The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Conditions

  • Non Alcoholic Steatohepatitis (NASH)

Interventions

DRUG

Obeticholic Acid

DRUG

Placebo

Sponsors & Collaborators

  • Intercept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Sangeeta Sawhney, MD · Intercept Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-22
Primary Completion
2023-09-15
Completion
2023-09-15

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • New Zealand
  • Poland
  • Portugal
  • Puerto Rico
  • Serbia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT02548351 on ClinicalTrials.gov