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
Key facts
- Where
- Debrecen, MagyarországSee the site
- Phase
- 3. fázis
Where in Magyarország
- University of DebrecenDebrecen, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Intercept Pharmaceuticals Inc.
- Trial code
- EU 2023-507771-22-01
- Record updated
- 2025. október 13.
- Original description
To assess the long-term safety and tolerability of the OCA + BZF FDC tablet (OCA 5 mg + BZF 400 mg SR) in subjects with PBC: • Biochemical disease markers, including ALP, GGT, ALT, AST, and total and conjugated bilirubin. • ALP <1.67 x ULN, total bilirubin ≤ULN, and ALP decrease of ≥15% from baseline. • Noninvasive assessments of liver fibrosis (TE, ELF score). • Disease severity scores (GLOBE, UK-PBC, and MELD). Please refer to the Protocol for detailsRead full original descriptionShow less
To assess the long-term safety and tolerability of the OCA + BZF FDC tablet (OCA 5 mg + BZF 400 mg SR) in subjects with PBC: • Biochemical disease markers, including ALP, GGT, ALT, AST, and total and conjugated bilirubin. • ALP <1.67 x ULN, total bilirubin ≤ULN, and ALP decrease of ≥15% from baseline. • Noninvasive assessments of liver fibrosis (TE, ELF score). • Disease severity scores (GLOBE, UK-PBC, and MELD). Please refer to the Protocol for details
Inclusion: Key Target Population: All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 (or other Sponsor studies) are included. Please refer to the Protocol for detailed Principal inclusion criteria.
Exclusion: Key Exclusion include: if they have a history or presence in the last 30 days, before rolling over to this study, of other concomitant liver diseases, varices, ascites/hepatic hydrothorax, spontaneous bacterial peritonitis, hepatic encephalopathy, or jaundice. Clinical complication of PBC including prior liver transplantation. Biochemical evidence of hepatic impairment, decompensation, or injury. Medical conditions that may cause non-hepatic increases in ALP. Presence of any other disease or condition that interferes with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. History of cholelithiasis or choledocholithiasis unless documented cholecystectomy, chronic pancreatitis/recurrent acute pancreatitis, drug-induced myopathy, chronic kidney disease or undergoing dialysis, HIV, clinically concerning cardiac arrhythmias, severe pruritus, or hypersensitivity to OCA, BZF. Please refer to the Protocol for detailed Principal exclusion criteria.