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
Study of Drug in Patients with Primary Biliary Cholangitis (PBC)
Sponsor: Zydus Pharmaceuticals
Enrolling: Male and Female Patients
Study Length: 26 Weeks
IRB Number: AAAR3471
U.S. Govt. ID: NCT03112681
Contact: Cristina Falo PhD: 212-305-6758 / cf2427@cumc.columbia.edu
Additional Study Information: This is a randomized, double-blinded, placebo-controlled phase 2 study. The purpose of this study is to evaluate the safety and efficacy of Saroglitazar magnesium 2 mg and 4mg versus placebo in the treatment of subjects with Primary Biliary Cholangitis. The research study consists of a Screening Phase (Visits 1 and 2) that lasts up to 42 days, a Treatment Phase (Visits 3 through 7) that will last 112 days, and a safety follow-up 4 weeks later. The research study lasts about 26 weeks.
This study is closed
Investigator
Julia Wattacheril, MD, MPH
Do You Qualify?
Are you between the ages of 18 and 75? Yes No
Have you been diagnosed with Primary Biliary Cholangitis (PBC)? Yes No
Do you have Hepatitis B/C, Primary sclerosing cholangitis (PSC), alcoholic liver disease, non-alcoholic steatohepatitis(NASH)? Yes No
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For more information, please contact:
Cristina Falo PhD
cf2427@cumc.columbia.edu
212-305-6758