A Phase 3, Open-Label, Long-Term Safety Extension Study Evaluating the Safety and Tolerability of the Fixed-Dose Combination of Obeticholic Acid and Bezafibrate in Subjects with Primary Biliary Cholangitis

Primary Biliary Cholangitis (PBC)

1. Response rate of ≥40% reduction from baseline and normalization rates of ALP;, 2. normalization rates of GGT, ALT, AST, total and conjugated bilirubin;, 3. change from baseline in GGT, ALT, ALP, AST, total and conjugated bilirubin, GLOBE scores, UK-PBC scores, MELD scores, and noninvasive markers of liver fibrosis, including liver stiffness measured by TE and ELF score;, 4. and percentage of subjects with ALP <1.67 x ULN, total bilirubin ≤ULN, and ALP decrease of ≥15% from baseline., 5. Please refer to the Protocol for detailed Primary end point.

1. Exploratory endpoints include change from baseline in NRS, PBC-40, FIS, and APRI. In addition, time to first occurrence of any of the following:, 2. death (all-cause), liver transplant, MELD score ≥15, hospitalization new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis, or hepatocellular carcinoma , portal hypertension syndromes, portal hypertension (clinically evident ascites or endoscopic evidence without bleeding), splenomegaly, and time to first occurrence of each individual component of the composite event endpoint., 3. Please refer to the Protocol for detailed Secondary end point.

No related papers found yet.

Belgium, Croatia, Czechia, Estonia, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Norway