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Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment

NCT03633227 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-09-06

Study results available
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Summary

This Phase 4, randomized, double-blind, placebo-controlled study will evaluate the pharmacokinetics (PK) and safety of OCA treatment in participants with PBC and moderate to severe hepatic impairment over a 48-week treatment period. Participants who have completed their 48-week double blind treatment period will continue double-blind treatment until all randomized participants have completed their 48-week treatment period and the database for that period is locked. An open-label extension study in which all participants receive OCA will be considered following review of blinded safety and PK data.

Conditions

  • Liver Cirrhosis, Biliary

Interventions

DRUG

Obeticholic Acid (OCA)

OCA will be administered per dose and schedule specified in the arm description.

DRUG

Placebo

OCA matching placebo will be administered per the schedule specified in the arm description.

Sponsors & Collaborators

  • Intercept Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Steven Shiff, M.D. · 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
2018-06-22
Primary Completion
2021-07-09
Completion
2021-07-09
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Estonia
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Spain

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 NCT03633227 on ClinicalTrials.gov