NCT05904470已完成2 期
A Phase 2, Open-label Study to Assess the Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic Hepatitis C Virus (HCV) Infection
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 1
- 主要终点
- Percentage of Subjects Achieving Sustained Virologic Response at 12 Weeks Post-treatment (SVR12)
研究概览
简要总结
This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent
- •Male or female subjects between ≥ 18 years of age (or the legal age of consent per local regulations) and ≤ 85 years of age
- •Female subjects of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to the use of an acceptable effective contraception
- •Females must have a negative pregnancy test at Screening and at Day 1 prior to dosing
- •Subjects must be direct-acting antiviral (DAA)-treatment-naïve, defined as never exposed to an approved or experimental DAA for HCV
- •Documented medical history compatible with chronic HCV
- •Liver disease staging assessment as follows:
- •Absence of cirrhosis (F0 to F3)
- •Compensated cirrhosis (F4)
排除标准
- •Female subject is pregnant or breastfeeding
- •Co-infected with hepatitis B virus (HBV; positive for hepatitis B surface antigen [HBsAg]) and/or human immunodeficiency virus (HIV)
- •Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
- •Prior exposure to any HCV DAA
- •Use of other investigational drugs within 30 days of dosing or plans to enroll in another clinical trial of an investigational agent while participating in the present study
- •Subject with known allergy to the study medications or any of their components
- •History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency
- •Cirrhotic and has a Child-Pugh score >6, corresponding to a Child-Pugh Class B or C
- •History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
- •Any other clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
研究组 & 干预措施
Bemnifosbuvir and Ruzasvir
Experimental
Bemnifosbuvir (BEM; AT-527) Tablets
Ruzasvir (RZR; AT-038) Capsules
干预措施: Bemnifosbuvir (Drug)
Bemnifosbuvir and Ruzasvir
Experimental
Bemnifosbuvir (BEM; AT-527) Tablets
Ruzasvir (RZR; AT-038) Capsules
干预措施: Ruzasvir (Drug)
结局指标
主要结局
Percentage of Subjects Achieving Sustained Virologic Response at 12 Weeks Post-treatment (SVR12)
时间窗: Day 1 through 12 weeks after end of treatment
SVR12 defined as plasma hepatitis C virus (HCV) RNA less than the lower limit of quantitation (\<LLOQ) at 12 weeks post-treatment
次要结局
- Percentage of Subjects Experiencing Virologic Failure(Day 1 through 12 weeks after end of treatment)
- Percentage of Subjects Achieving Sustained Virologic Response at 24 Weeks Post-treatment (SVR24)(Day 1 through 24 weeks after end of treatment)
研究者
研究点 (1)
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