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)

Condition studied

Primary Biliary Cholangitis (PBC)

Investigational medicinal product(s)

Every trial of Saroglitazar Magnesium across our registers →

Eligibility

Primary endpoint

Time from randomization to the first occurrence of any of the following clinical outcome events: • Liver decompensation • Change in the MELD-Na score to ≥15 • Liver transplant • Death (liver- and nonliver-related) • Progression to CSPH, defined as the development of large varices (>5 mm in diameter) in participants who had no varices at baseline. • Progression to CPT C, defined as CPT score ≥10 For more information, please refer to the Protocol.

Endpoint detail

• The incidence of achieving normalization of ALP, defined as ALP ≤ULN at Month 48. • The incidence of achieving normalization of ALP, defined as ALP ≤ULN at Month 12. • Time from randomization to the first occurrence of any of the following clinical outcome events: o Liver decompensation o Liver transplant o Death • The percentage of participants with stabilization in Total Bilirubin. • Change from baseline in the PBC-40 QoL questionnaire (1-week recall) fatigue domain score at Month 12.