NCT04019717已完成2 期
A Phase 2 Study Assessing the Safety and Efficacy of AT-527 in Combination With Daclatasvir in Subjects With Chronic 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
- 10
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving sustained virologic response (SVR)
研究概览
简要总结
The study will assess the safety and efficacy of AT-527 in combination with daclatasvir after 8 or 12 weeks of treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) of 18-35 kg/m2
- •Must agree to use protocol-specified methods of contraception
- •Negative pregnancy test
- •HCV genotype 1
- •Documented history compatible with chronic hepatitis C
- •HCV RNA ≥ 10,000 IU/mL at Screening.
- •Willing to comply with the study requirements and to provide written informed consent
排除标准
- •Pregnant or breastfeeding
- •Infected with hepatitis B virus or HIV
- •Abuse of alcohol or drugs
- •Prior exposure to any HCV NS5A inhibitor
- •Cirrhosis
- •Use of other investigational drugs within 30 days of dosing
- •Other clinically significant medical conditions or contraindications to daclatasvir
研究组 & 干预措施
8 weeks
Experimental
干预措施: AT-527 (Drug)
8 weeks
Experimental
干预措施: Daclatasvir (Drug)
12 weeks
Experimental
干预措施: AT-527 (Drug)
12 weeks
Experimental
干预措施: Daclatasvir (Drug)
结局指标
主要结局
Proportion of subjects achieving sustained virologic response (SVR)
时间窗: 12 weeks after end of treatment
SVR defined as the HCV RNA \< lower limit of quantitation (LLOQ) at 12 weeks after end of treatment
Incidence of treatment-emergent adverse events
时间窗: Through 4 weeks after end of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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