A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients with Primary Biliary Cholangitis (EPICS )
ID Number 17-1045Principal Investigator(s)
Joseph A Odin
Department(s) or Division(s)
This is a Phase 2 prospective, multicenter, randomized, double-blind, placebo-controlled study planned to enroll a total of 36 patients from 10-12 sites with a diagnosis of Primary Biliary Cholangitis (PBC) who meet the study's inclusion/exclusion criteria.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of Saroglitazar magnesium in patients with PBC.
During the study drug treatment period, they will either receive Saroglitazar magnesium (2 mg and 4 mg) or placebo.
This study will be conducted over a period of up to 26 weeks and will include a 6-week Screening Phase, a 16-week double-blind Treatment Phase and a safety follow-up visit after 4 weeks.
The number of people expected to take part in this research study at this site is 2-3. The total number of people expected to take part in this research study is 36.
Recruiting Patients: Yes