A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase

Trial Profile

A Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of Oral GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodeoxycholic Acid and With Persistently Elevated Alkaline Phosphatase

Recruiting
Phase of Trial: Phase II

Latest Information Update: 30 Nov 2017

At a glance

  • Drugs GKT 831 (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Therapeutic Use
  • Sponsors GenKyoTex
  • Most Recent Events

    • 26 Oct 2017 According to a GenKyoTex media release, patient enrollment is on track.
    • 03 Sep 2017 According to a GenKyoTex media release, dosing of the first patient is expected shortly.
    • 27 Jun 2017 According to a GenKyoTex media release, this study got regulatory clearance by the U.S. Food & Drug Administration and local Institutional Review Board. Dosing of the first patient is expected shortly.
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