NCT02613871已完成3 期
A Phase 3b Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 2 Hepatitis C Virus (HCV) and Hepatitis B Virus (HBV) Coinfection
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 111
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
The primary objectives of this study are to determine the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in adults with chronic genotype 1 or 2 HCV infection who are coinfected with HBV in Taiwan.
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
- •Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection
- •Individuals must not be taking or requiring treatment with HBV antiviral therapy at screening. For participants that are HBV treatment experienced, the most recent treatment must have been completed at least 6 months prior to Day
- •Cirrhosis determination by Fibroscan
- •Screening laboratory values within defined thresholds
- •Use of two effective contraception methods if female or male is of childbearing potential
排除标准
- •Current or prior history of clinically-significant illness or any other major medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
- •Pregnant or nursing female
- •Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)
- •Hepatocellular carcinoma (HCC) or other malignancy
- •Current or prior history of clinical hepatic decompensation
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LDV/SOF
Experimental
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) 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantification (LLOQ; 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug
时间窗: First dose date up to 12 weeks
次要结局
- HCV RNA Change From Baseline While on Treatment(Weeks 1, 2, 4, 8, and 12)
- Percentage of Participants With HCV RNA < LLOQ While on Treatment(Weeks 1, 2, 4, 8, and 12)
- Percentage of Participants With Virologic Failure(First dose date up to Posttreatment Week 12)
- Plasma HBV DNA Change From Baseline While on Treatment(Weeks 1, 2, 4, 8, and 12)
- HBsAg Level Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108(Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108)
- Plasma HBV DNA Change From Baseline at Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108(Posttreatment Weeks 4, 12, 24, 36, 48, 60, 72, 84, 96, and 108)
- HBsAg Level Change From Baseline While on Treatment(Weeks 1, 2, 4, 8, and 12)
- Serum LOXL-2 Level Change From Baseline While on Treatment(Weeks 1, 2, 4, 8, and 12)
- Percentage of Participants That Required HBV Therapy During the Study(First dose date up to Posttreatment Week 108)
- Fibrosis Status as Assessed by Fibroscan Score at Posttreatment Weeks 12, 60, and 108(Posttreatment Weeks 12, 60, and 108)
- Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During the Study(First dose date up to Posttreatment Week 108)
- Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108(Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108)
- Serum LOXL-2 Level Change From Baseline at Posttreatment Weeks 4, 12, and 36(Posttreatment Weeks 4, 12, and 36)
研究者
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