Long-Term Study of Saroglitazar Magnesium for Primary Biliary Cholangitis
This study is looking at how safe and effective a drug called saroglitazar magnesium is for people with primary biliary cholangitis (PBC), a chronic liver disease. You would either receive saroglitazar magnesium 1 mg or a placebo (an inactive substance that looks like the drug) once daily. Researchers will compare these two groups to see if saroglitazar magnesium can prevent certain clinical events related to PBC over a period of up to 48 months. Adults aged 18 and older who can provide informed consent are eligible to participate. The current recruitment status is unclear.
- Study design
- This is a long-term, double-blind, placebo-controlled study, meaning neither you nor your doctor will know if you are receiving the active drug or placebo. It aims to enroll 386 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for up to 48 months (4 years) to track clinical outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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What this trial measures
- To evaluate the effect of saroglitazar magnesium compared to placebo, based on time to the first occurrence of the defined clinical outcome events in participants with PBC.baseline to 48 months
Time from randomization to the first occurrence of any of the following clinical outcome events: * Liver decompensation * Change in the Model for End-Stage Liver Disease-Na score to ≥15, measured on 2 consecutive occasions, performed at least 2 weeks apart, without the presence of any competing etiologies. * Liver transplant. * Death (liver- and nonliver-related). * Progression to clinically significant portal hypertension, defined as the development of large varices (\>5 mm in diameter) in participants who had no varices at baseline * Progression to Child-Pugh-Turcotte C, defined as Child-Pugh-Turcotte score ≥10, measured at 2 consecutive time points at least 4 weeks apart with no competing etiologies