At a glance
ClinicalIndex Comparison Record- ✓Age 18–75 years
- ✓On UDCA at therapeutic doses for ≥12 months and stable for ≥3 months prior to enrollment, OR unable to tolerate UDCA with ≥3 months off UDCA
- ✓Confirmed PBC diagnosis by AASLD/EASL criteria: ≥2 of (1) elevated ALP ≥6 months, (2) positive AMA or PBC-specific antibodies, (3) liver biopsy consistent with PBC
- ✓Alkaline phosphatase ≥1.67× ULN at both Visit 1 and Visit 2 with <30% variance between visits
- ✕Alcohol consumption >3 units/day (>21 units/week) for males or >2 units/day (>14 units/week) for females for ≥3 consecutive months in past 5 years
- ✕Concomitant liver disease: hepatitis B or C, primary sclerosing cholangitis, alcoholic liver disease, autoimmune liver disease overlap syndrome, or NASH
- ✕Cirrhosis with complications: spontaneous bacterial peritonitis, hepatocellular carcinoma, bilirubin >2× ULN, ascites, encephalopathy, esophageal varices, variceal bleeding, or hepatorenal syndrome
- ✕History of venous thromboembolism, TIA, intracranial hemorrhage, neoplasm, arteriovenous malformation, vasculitis, or bleeding/coagulation disorders; abnormal coagulation studies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 (EPICS )
In Brief
A Phase 2 clinical trial evaluating Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg, and 1 other intervention for Primary Biliary Cirrhosis. Completed, enrolled 37 participants across 9 sites.
Detailed Summary
prospective, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability and efficacy of saroglitazar magnesium 2 mg, 4 mg in Patients with Primary Biliary Cholangitis (PBC). A total 36 subjects will be enrolled in a ratio of 1:1:1 to receive either saroglitazar magnesium 2 mg or saroglitazar magnesium 4 mg or placebo.
Study Details
Timeline
Interventions
Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.