A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Faldaprevir and TD 6450 Alone and in Combination With Other Antivirals for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 1 Hepatitis C Virus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals with and without ribavirin in Genotype 1b Hepatitis C infected adults
研究概览
简要总结
Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.
详细描述
A study to evaluate the safety and effect of treatment with experimental antiviral drugs alone or in combination with ribavirin in treatment-naïve participants with genotype 1b hepatitis C infection. The study will test the safety and anti-viral activity of two regimens administered for a duration of 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
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic genotype 1b 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 (kilopascals)
- •A non-invasive test measuring liver scarring (FibroSure®) score ≤ 0.48 and AST (aspartate aminotransferase):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
Cohort 1
12 weeks of Faldaprevir plus TD-6450 plus Ribavirin
干预措施: Faldaprevir (Drug)
Cohort 1
12 weeks of Faldaprevir plus TD-6450 plus Ribavirin
干预措施: TD-6450 (Drug)
Cohort 1
12 weeks of Faldaprevir plus TD-6450 plus Ribavirin
干预措施: Ribavirin (Drug)
Cohort 2
12 weeks of Faldaprevir plus TD-6450
干预措施: Faldaprevir (Drug)
Cohort 2
12 weeks of Faldaprevir plus TD-6450
干预措施: TD-6450 (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 with and without ribavirin in Genotype 1b Hepatitis C infected adults
时间窗: Post Treatment Week 12
次要结局
- 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 with and without ribavirin)(Post Treatment Weeks 2 to 8)
- Safety as determined by the incidence of serious adverse events, Grade 3 or 4 adverse events and laboratory abnormalities, and discontinuations due to adverse events(Randomization through End of Study, up to 24 weeks)