NCT01924949已完成2 期
An Open-Label Study of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks in Subjects With Nosocomial Genotype 1 HCV Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
This study is to evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with nosocomial 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) greater than or equal to 18 kg/m^
- •HCV RNA greater than or equal to 1000 IU/mL at screening.
- •Documented acquisition of nosocomial genotype 1 HCV infection within 36 months from the screening visit.
- •Screening laboratory values within predefined thresholds.
- •Use of two effective contraception methods if female of childbearing potential or sexually active male.
- •Healthy according to medical history and physical examination with the exception of HCV diagnosis.
排除标准
- •Unstable cardiac disease including subjects with active angina pectoris and/or hospitalization for a cardiac condition within 24 weeks prior to screening.
- •Prior exposure to an HCV NS5a inhibitor.
- •Pregnant or nursing female.
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
- •History of solid organ transplantation.
- •Current or prior history of clinical hepatic decompensation.
- •History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
- •Known hypersensitivity to LDV, SOF, or formulation excipients.
研究组 & 干预措施
LDV/SOF
Experimental
Participants will receive LDV/SOF FDC 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 (SVR) at 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) at 12 weeks after stopping study treatment.
Percentage of Participants Permanently Discontinuing Study Drug Due to an Adverse Event
时间窗: Up to 12 weeks
次要结局
- HCV RNA Change From Baseline(Baseline; Weeks 1, 4, and 8)
- Percentage of Participants Experiencing Virologic Failure(Baseline to posttreatment Week 24)
- 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 With HCV RNA < LLOQ on Treatment(Up to 12 weeks)
研究者
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