A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 384
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent
- •HCV RNA ≥ 10^4 IU/mL at screening
- •HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
- •Genotype 1 HCV at screening
- •HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy
排除标准
- •Pregnant or nursing female
- •Chronic liver disease of a non-HCV etiology
- •Current or prior history of any clinically-significant illness (other than HCV)
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
LDV/SOF
Treatment-experienced and treatment-naive participants will receive LDV/SOF for 12 weeks.
干预措施: LDV/SOF (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 25 IU/mL in Korea and Taiwan and \< 15 IU/mL in China) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
时间窗: Up to 12 weeks
次要结局
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants Experiencing Viral Relapse(Week 12 to Posttreatment Week 24)
- HCV RNA and Change From Baseline in HCV RNA Through Week 12 for China Only(Baseline; Week 12)
- Percentage of Participants Experiencing Viral Breakthrough(Up to 12 weeks)