Clinical Trial: A Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With Primary Biliary Cholangitis (EPICS)

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2, Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Magnesium in Patients With P

Brief Summary: Study SARO.16.004.02 is a prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis. A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo. The primary objective is to investigate the effect of a 16-week treatment regimen of Saroglitazar magnesium 2 mg and 4 mg on ALP levels in patients with Primary Biliary Cholangitis.

Detailed Summary:
Sponsor: Zydus Discovery DMCC

Current Primary Outcome: Effect of a 16-week treatment regimen of Saroglitazar magnesium 2 mg and 4 mg on ALP levels in patients with Primary Biliary Cholangitis. [ Time Frame: 16 Weeks ]

Improvement in ALP levels after 16 weeks of Saroglitazar magnesium 2 mg and 4 mg treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Zydus Discovery DMCC

Dates:
Date Received: April 10, 2017
Date Started: April 2017
Date Completion: March 2019
Last Updated: April 12, 2017
Last Verified: April 2017