Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy
Adults between 18 and 80 years of age (both inclusive at screening)
History of confirmed Primary Biliary Cholangitis diagnosis
Ursodeoxycholic acid treatment for at least 12 months and a stable dose for at least 6 months prior to first screening visit OR intolerant to Ursodeoxycholic acid (last dose of Ursodeoxycholic acid at least 3 months prior to first screening visit).
Average Alkaline Phosphatase at both screening Visits 1 and 2: > 1× Upper Limit of Normal and < 1.67× Upper Limit of Normal, and < 30% variance between both levels
Consumption of 14 or more standard alcohol drinks per week if male and 7 or more standard alcohol drink per week if female for at least 3 consecutive months (i.e., 12 consecutive weeks) within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits/hard liquor).
History or presence of other concomitant liver diseases at screening
Cirrhosis with complications, including history or presence of the following: spontaneous bacterial peritonitis, hepatocellular carcinoma, ascites requiring treatment, encephalopathy, known large esophageal varices, or history of variceal bleeding within one year prior to screening or history of hepatorenal syndrome.
Medical conditions that may cause non-hepatic increases in Alkaline Phosphatase (e.g., Paget's disease) or which may diminish life expectancy to < 2 years, including known cancers.
Parallel
Saroglitazar Magnesium 1 mg
DrugSaroglitazar magnesium 1 mg once daily, orally each morning before breakfast
Placebo
DrugMatching Placebo once daily, orally each morning before breakfast
The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP
The incidence of participants with ALP ≤ ULN and ≥ 15% decrease from baseline in ALP
Change from baseline in the Global PBC Study Group (GLOBE) scores
The GLOBE score is a prognostic scoring system that incorporates various clinical and laboratory parameters to predict the long-term outcome and survival of patients with PBC. Lower GLOBE score predicts lower risk. It is calculated from the following equation: GLOBE score = 0.044378 × age at start of UDCA therapy + 0.93982 × ln(bilirubin × ULN at 1 year follow-up) + 0.335648 × ln(ALP × ULN at 1 year follow-up) - 2.266708 × albumin level × the lower limit of normal (LLN) at 1 year follow-up -0.002581 × platelet count per 10\^9/L at 1 year follow-up +1.216865.
Change from baseline in the United Kingdom Primary Biliary Cholangitis (UK-PBC)
The UK-PBC risk score is a scoring system specifically developed for risk stratification and prognosis in patients with PBC. The higher the score might indicate higher risk to death or live transplantation. UK-PBC risk score = 1 - baseline survival function∧ exp(0.0287854 × \[ALP after 12 months of therapy × ULN - 1.722136304\] - 0.0422873 × \[{(ALT where this was available, otherwise AST, after 12 months of therapy × ULN/10)∧-1} - 8.675729006\] + 1.4199 × \[ln{bilirubin after 12 months of therapy × ULN/10} + 2.709607778\] - 1.960303 × \[albumin at baseline × LLN - 1.17673001\] - 0.4161954 × \[platelet count at baseline × LLN -1.873564875\]).
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