Phase 2a, Randomized, Double-Blind Study to Investigate the Safety and Efficacy of Faldaprevir in Combination With Ribavirin and TD-6450 for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 4 Hepatitis C Virus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals and ribavirin in Genotype 4 Hepatitis C infected adults
研究概览
简要总结
Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve participants with genotype 4 hepatitis C virus (HCV) infection.
详细描述
A study to evaluate the safety and effect of treatment with experimental antiviral drugs in combination with ribavirin in treatment-naïve participants with genotype 4 hepatitis C infection. The study will test the safety and effects of this alternative treatment for up to 12 weeks. Secondary objectives of this study are to determine the pharmacokinetics of the study drugs when co-administered, and to evaluate HCV RNA kinetics during treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic genotype 4 hepatitis C infection and HCV RNA ≥ 10^4 IU/mL at screening
- •Hepatitis C virus treatment naive, defined as defined as having never received a direct acting anti-viral (DAA), and as having received ≤ 8 weeks of interferon ≥ 6 months prior to screening
- •Absence of cirrhosis as defined by one of the following:
- •A liver biopsy performed within 24 calendar months of Day 1 showing absence of cirrhosis
- •Transient elastography (FibroScan®) performed within 12 calendar months of Day 1 with a result of ≤ 12.5 kPa
- •A FibroSure® score ≤ 0.48 and AST:platelet ratio (APRI) ≤ 1 performed during screening
排除标准
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2
研究组 & 干预措施
Group 1
12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
干预措施: Faldaprevir (Drug)
Group 1
12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
干预措施: TD-6450 (Drug)
Group 1
12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin
干预措施: Ribavirin (Drug)
Group 2
12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
干预措施: Faldaprevir (Drug)
Group 2
12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
干预措施: TD-6450 (Drug)
Group 2
12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals and ribavirin in Genotype 4 Hepatitis C infected adults
时间窗: Post Treatment Week 12
次要结局
- Percentage of subjects with virologic response at Week 12 (HCV RNA less than lower limit of quantitation at end of therapy with Faldaprevir plus TD-6450 plus ribavirin)(Week 12)
- Percentage of subjects with virologic response 2, 4 and 8 weeks after treatment completion (HCV RNA less than lower limit of quantitation at 2, 4 and 8 weeks after end of therapy with Faldaprevir plus TD-6450 plus ribavirin)(Post Treatment Weeks 2 to 8)