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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 15
- 主要终点
- The response rates of reduction from baseline and normalization rates of ALP; normalization rates of GGT, ALT, AST, total and total and conjugated bilirubin; change from baseline in GGT, ALT, ALP, AST, conjugated bilirubin, C4, and bile acids. Please refer to the Protocol for detailed Primary end point.
研究概览
简要总结
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 by: • Biochemical disease markers, including ALP, GGT, ALT, AST, and total and conjugated bilirubin. • Biomarkers of bile acid synthesis and homeostasis, including 7α-hydroxy-4-cholesten-3-one (C4) and bile acids.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- Key Target Population: All subjects with PBC who participated and are actively taking investigational product in Study 747-213 or Study 747-214 are included. Please refer to the Protocol for detailed Principal inclusion criteria.
排除标准
- 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. Complication of PBC including history of liver transplant or current MELD score Biochemical evidence of hepatic impairment, decompensation, or injury>12. 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 gallbladder diseases, 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.
结局指标
主要结局
The response rates of reduction from baseline and normalization rates of ALP; normalization rates of GGT, ALT, AST, total and total and conjugated bilirubin; change from baseline in GGT, ALT, ALP, AST, conjugated bilirubin, C4, and bile acids. Please refer to the Protocol for detailed Primary end point.
The response rates of reduction from baseline and normalization rates of ALP; normalization rates of GGT, ALT, AST, total and total and conjugated bilirubin; change from baseline in GGT, ALT, ALP, AST, conjugated bilirubin, C4, and bile acids. Please refer to the Protocol for detailed Primary end point.
次要结局
- The additional endpoints include change from baseline in non-invasive markers of liver fibrosis, change from baseline in the GLOBE, UK-PBC, NRS, PBC-40, pruritus VAS, EQ-5D-5L, FIS, and APRI.
- In addition, percentage of subjects with ALP <1.67x ULN, total bilirubin ≤ULN, and ALP decrease of ≥15% from baseline, and time to first occurrence of any of the following: death (all-cause), liver transplant, MELD score ≥15, hospitalization, or HCC. Please refer to the Protocol for detailed Secondary end point.
研究者
Clinical Reaserch
Scientific
Intercept Pharmaceuticals Inc.
研究点 (15)
标识符
- 欧盟试验编号
- 2023-507771-22-01
- 其他研究编号
- 977-311
日期
- 首次发布
- (去年)
- 最近更新
- (去年)
监管与共享
- 个体参与者数据共享计划
- Undecided
- 是否有结果
- 否