A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)
Zydus Therapeutics Inc.
Summary
Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)
Description
A Phase 3b/4, Multicenter, Parallel Group, Double Blind, Placebo Controlled, Two Arm, Long Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants with Primary Biliary Cholangitis (PBC)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Each participant must meet all of the following criteria to be enrolled in this study: 1. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements 2. Is an adult male or female, must be ≥18 years of age at the time of signing informed consent 3. Is receiving ursodeoxycholic acid (UDCA) for ≥12 months with a stable dose for ≥6 months prior to screening,and expected to remain on a stable dose during the study period OR Is unable to tolerate UDCA and did not receive UDCA…
Interventions
- DrugSaroglitazar magnesium 1 mg
Saroglitazar magnesium 1 mg once daily, orally each morning before breakfast
- DrugPlacebo
Matching Placebo once daily, orally each morning before breakfast
Locations (3)
- Zydus US104Marietta, Georgia
- Zydus US101Indianapolis, Indiana
- Zydus US105Houston, Texas