A Multicenter Treatment Protocol of Daclatasvir (BMS-790052) in Combination With Sofosbuvir for the Treatment of Subjects With Chronic Hepatitis C and Decompensated Cirrhosis or Post-Liver Transplant Subjects With Chronic Hepatitis C Recurrence

Bristol-Myers Squibb20 个研究点分布在 1 个国家开始时间: 2014年6月12日最近更新: 2016年1月29日

适应症

试验速览

阶段: 不适用
状态: No Longer Available
发起方
试验地点: 20

研究概览入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of this program is to provide DCV for 24 weeks to be given in combination with SOF to subjects with chronic hepatitis C with decompensated cirrhosis or post-liver transplant subjects with chronic hepatitis C recurrence with either advanced fibrosis or fibrosing cholestatic hepatitis and who have a serious or immediately life-threatening condition or experienced an event that has decreased their life expectancy to <12 months, therefore, no research hypothesis will be tested and no specific endpoints are defined. However, safety data will be collected throughout the study as well as efficacy data

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients chronically infected with Hepatitis C
•Subjects who received a liver transplant, have chronic hepatitis C virus (HCV) recurrence and advanced fibrosis (Metavir F3-F4) or fibrosing cholestatic hepatitis
•Subjects with decompensated cirrhosis defined by Child-Pugh Class C

排除标准

•Patients who are <18 years old
•Clinical or pathologic evidence of acute ongoing liver graft rejection
•Creatinine clearance (CrCl) ≤30 mL/min (as estimated by Cockcroft and Gault formula)
•Patients who have contraindications to either Daclatasvir (DCV) or Sofosbuvir (SOF)
•Patients who are pregnant or Women of Child Bearing Potential who are not using required contraception

研究者

发起方

Bristol-Myers Squibb

申办方类型

Industry

责任方

Sponsor

研究点 (20)

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