An Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 or 24 Weeks in Genotype 1 or 4 HCV Infected Subjects With Sickle Cell Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
研究概览
简要总结
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) administered for 12 or 24 weeks in adults with genotype 1 or 4 hepatitis C virus (HCV) infection with sickle cell disease (SCD).
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
- •Chronic genotype 1 or 4 infected patients with sickle cell disease
- •HCV RNA ≥ 1,000 IU/mL at screening
- •Cirrhosis determination by transient elastography
- •Screening laboratory values within defined thresholds
- •Use of two effective contraception methods if female of childbearing potential or sexually active male
排除标准
- •Pregnant or nursing female
- •Co-infection with HIV or hepatitis B virus (HBV)
- •Current or prior history of clinical hepatic decompensation
- •Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- •History of clinically significant illness or any other medical disorder that may interfere with treatment, assessment or compliance with the protocol
- •Note: Other protocol defined inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LDV/SOF 12 weeks
Treatment-naive or treatment-experienced participants without cirrhosis will receive LDV/SOF for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF 24 weeks
Treatment-experienced participants with cirrhosis will receive LDV/SOF for 24 weeks.
干预措施: LDV/SOF (Drug)
结局指标
主要结局
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 24 weeks
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) 12 weeks following the last dose of study drug.
次要结局
- Percentage of Participants With HCV RNA < LLOQ on Treatment(Weeks 1, 2, 4, 8,12, 16, 20, and 24)
- HCV RNA Change From Baseline(Up to 24 weeks)
- Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Physical Component Score(Weeks 4,12, 24, Posttreatment Weeks 4 and 12)
- Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Short Form (SF-36) Health Survey Scale- Mental Component Score(Weeks 4,12, 24, Posttreatment Weeks 4 and 12)
- Change From Pretreatment Assessment in Health-related Quality of Life as Evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(Weeks 4,12, 24, Posttreatment Weeks 4 and 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 12)