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
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 |
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
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 |