Clinical Trial: Safety, Tolerability, and Efficacy of GS 9674 in Adults With Primary Biliary Cholangitis Without Cirrhosis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 2, Randomized, Double-Blind, Placebo Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Primary Biliary Cholangitis Wit
Brief Summary: The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in adults with primary biliary cholangitis (PBC).
Detailed Summary:
Sponsor: Gilead Sciences
Current Primary Outcome:
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Up to 12 weeks plus 30 days ]
- Incidence of Treatment-Emergent Serious Adverse Events [ Time Frame: Up to 12 weeks plus 30 days ]
- Incidence of treatment-emergent laboratory abnormalities [ Time Frame: Up to 12 weeks plus 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Gilead Sciences
Dates:
Date Received: June 13, 2016
Date Started: December 1, 2016
Date Completion: February 2020
Last Updated: May 19, 2017
Last Verified: May 2017