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Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid

NCT03124108 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-09-24

Study results available
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Summary

The primary objective of the study is to compare the effect of daily oral administration of elafibranor 80mg and 120 mg on change in serum alkaline phosphatase (ALP) to that of placebo in patients with PBC and inadequate response to Ursodeoxycholic acid (UDCA).

Conditions

  • Primary Biliary Cholangitis (PBC)

Interventions

DRUG

Elafibranor 80 mg

Two coated tablets daily for 12 weeks

DRUG

Elafibranor 120 mg

Two coated tablets daily for 12 weeks

DRUG

Placebo

Two coated tablets daily for 12 weeks

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Clinical Head · Genfit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2018-10-31
Completion
2018-10-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Spain
  • 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 NCT03124108 on ClinicalTrials.gov