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
Phase of Trial: Phase II
Latest Information Update: 21 Aug 2017
At a glance
- Drugs GKT 831 (Primary)
- Indications Primary biliary cirrhosis
- Focus Therapeutic Use
- Sponsors GenKyoTex
- 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.
- 27 Jun 2017 Status changed from planning to recruiting, according to a GenKyoTex media release.
- 02 May 2017 According to a GenKyoTex media release, this trial is expected to initiate prior to the end of the second quarter 2017, with interim top-line results anticipated in the first half of 2018, and full results anticipated in the second half of 2018.