At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 111 enrolled
Drug / intervention
GKT137831 +1 moredrug
Likely dose
GKT137831 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy & Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase
In Brief
A Phase 2 clinical trial evaluating GKT137831 and Placebo oral capsule for Primary Biliary Cirrhosis. Completed, enrolled 111 participants across 61 sites in 9 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cirrhosis
CountriesBelgium, Canada, Germany, Greece, Israel, Italy, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartJun 2017
First PostedJul 2017
Primary CompletionApr 2019
TodayJul 2026
First PostedJul 21, 2017
Enrollment StartJun 26, 2017
Primary CompletionApr 11, 2019
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 8.9 years ago
Interventions
GKT137831drug
GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.
Placebo oral capsuledrug
Matching capsules.