Open-label Rollover Study of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 167
- 试验地点
- 71
- 主要终点
- Number of Participants With Treatment-emergent Adverse Events (AE)
研究概览
简要总结
This rollover study will provide open-label treatment with cenicriviroc and will assess the long-term safety of continued treatment with cenicriviroc in participants who participated in either the CENTAUR study 652-2-203 [NCT02217475] or the AURORA study [NCT03028740].
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Successful completion of both Treatment Period 1 and Treatment Period 2, of the CENTAUR Study (652-2-203), including a Year 2 liver biopsy.
- •Completed the AURORA study (3152-301-002) as a result of reaching an adjudicated liver-related clinical outcome in Part 1 or Part 2 of the study of:
- •Histopathological progression to cirrhosis
- •Model for end-stage liver disease (MELD) score ≥ 15
- •Ascites (requiring intervention, ie, large volume paracentesis ≥ 1L or initiation of a diuretic)
- •Hospitalization (as defined by a stay of ≥ 24 hours) for onset of variceal bleed, hepatic encephalopathy (defined by a West Haven Stage of ≥ 2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis with positive ascitic fluid bacterial culture).
排除标准
- •Prior or planned liver transplantation
- •Other know causes of chronic liver disease such as: Alcoholic liver disease, Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis, Wilson's disease, hemochromatosis, or iron overload, or Alpha-1 antitrypsin (A1AT) deficiency.
研究组 & 干预措施
Cenicriviroc (CVC) 150 mg
Cenicriviroc 150 mg tablet once daily in the morning with food until the study was terminated (up to approximately 4 years).
干预措施: Cenicriviroc (Drug)
结局指标
主要结局
Number of Participants With Treatment-emergent Adverse Events (AE)
时间窗: Day 1 until the study was terminated (up to approximately 4 years)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment. A treatment-emergent AE is an AE that occurs after a participant receives study drug.
次要结局
未报告次要终点