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Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.

NCT03226067 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2022-06-29

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).

Conditions

  • Primary Biliary Cirrhosis

Interventions

DRUG

GKT137831

GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.

DRUG

Placebo oral capsule

Matching capsules.

Sponsors & Collaborators

  • Calliditas Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Philippe Wiesel, MD · Calliditas Therapeutics AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-06-26
Primary Completion
2019-04-11
Completion
2019-04-11
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Greece
  • Israel
  • Italy
  • Spain
  • United Kingdom

Study Locations

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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 NCT03226067 on ClinicalTrials.gov