A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 主要终点
- Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event
研究概览
简要总结
This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.
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 RNA ≥ 10^4 IU/mL at screening
- •Chronic genotype 4 or 5 HCV Infection
- •Individuals may be treatment naive or treatment experienced
- •Presence or absence of cirrhosis, a liver biopsy may be required
- •Healthy according to medical history and physical examination with the exception of HCV diagnosis
- •Agree to use two forms of highly effective contraception for the duration of the study
排除标准
- •History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
- •Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
- •History of any other clinically significant chronic liver disease
- •Evidence of or history of decompensated liver disease
- •HIV or chronic hepatitis B (HBV) infection
- •Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- •Chronic use of immunosuppressive agents or immunomodulatory agents
研究组 & 干预措施
Genotype 4
LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection
干预措施: LDV/SOF (Drug)
Genotype 5
LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection
干预措施: LDV/SOF (Drug)
结局指标
主要结局
Percentage of Participants Who Permanently Discontinued LDV/SOF Due to an Adverse Event
时间窗: Up to 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 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, 15 IU/mL) at 12 weeks after stopping study treatment.
次要结局
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Patients With Virologic Failure(Up to posttreatment Week 24)
- Change From Baseline in HCV RNA at Weeks 2, 4, 8, and 12(Baseline; Weeks 2, 4, 8, and 12)