A Phase 2, Open-Label Study to Investigate the Efficacy and Safety of an 8-Week and 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naïve or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection With and Without Cirrhosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)
研究概览
简要总结
This study will look at the safety and efficacy of 8 week and 12 week treatment with Sofosbuvir and Simeprevir in treatment-naïve and treatment-experienced patients with chronic hepatitis C genotype 4.
详细描述
Patients with confirmed absence of cirrhosis will receive 8 weeks of treatment with Sofosbuvir and Simeprevir. Patients with confirmed presence of cirrhosis will receive 12 weeks of treatment with Sofosbuvir and Simeprevir. All patients will followed for 24 weeks post-treatment. Presence or absence of cirrhosis will be evaluated by FibroScan if no historical liver biopsy or FibroScan is available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •HCV genotype 4 infection
- •HCV RNA >10,000 IU/mL at screening.
排除标准
- •Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).
- •Any liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis, or any other non-HCV liver disease considered clinically significant by the investigator.
- •Infection/co-infection with HCV non-genotype
- •Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).
- •Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen [HBsAg] positive).
- •Presence of significant co-morbidities or conditions that would compromise the subject's safety and could interfere with the subject's participation for the full duration of the study in the opinion of the investigator
- •Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection.
研究组 & 干预措施
Cirrhosis
Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir
干预措施: Simeprevir (Drug)
Cirrhosis
Patients with confirmed presence of cirrhosis will received 12 weeks of treatment with Sofosbuvir and Simeprevir
干预措施: Sofosbuvir (Drug)
Non-Cirrhotic
Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir
干预措施: Simeprevir (Drug)
Non-Cirrhotic
Patients with confirmed absence of cirrhosis will received 8 weeks of treatment with Sofosbuvir and Simeprevir
干预措施: Sofosbuvir (Drug)
结局指标
主要结局
Sustained Virologic Response 12 Weeks after Treatment Completion (SVR12)
时间窗: 12 weeks post-treatment
HCV RNA will be measured 12 weeks post-treatment to evaluate SVR
次要结局
- Sustained Virologic Response 4 and 24 Weeks after Treatment Completion(4 and 24 weeks post-treatment)
研究者
Peter J. Ruane, M.D.
Principal Investigator, President
Peter J. Ruane, M.D., Inc.