MedTrace Logo

Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis

NCT01473524 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 217

Last updated 2021-05-06

Study results available
· View outcomes & findings →

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).

Conditions

  • Primary Biliary Cirrhosis

Interventions

DRUG

Obeticholic Acid (OCA)

OCA was administered orally once daily and provided in tablet form in 2 strengths: 5 mg and 10 mg.

DRUG

Placebo

Matching placebo tablets were administered orally once daily.

Sponsors & Collaborators

  • Intercept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Christian Weyer, MD · Intercept Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-12-31
Completion
2018-12-17

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • 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 NCT01473524 on ClinicalTrials.gov