2023-504566-28-00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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 12
- 主要终点
- The primary efficacy endpoint is SVR12. The proportion of subjects achieving SVR12 with two-sided 95% CIs using the Wilson score method will be presented. Reasons for failure to achieve SVR12 will be summarized.
研究概览
简要总结
To evaluate the safety and tolerability of BEM + RZR. To evaluate the efficacy of BEM + RZR as assessed by the proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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 of childbearing potential 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
- •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
- •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
结局指标
主要结局
The primary efficacy endpoint is SVR12. The proportion of subjects achieving SVR12 with two-sided 95% CIs using the Wilson score method will be presented. Reasons for failure to achieve SVR12 will be summarized.
The primary efficacy endpoint is SVR12. The proportion of subjects achieving SVR12 with two-sided 95% CIs using the Wilson score method will be presented. Reasons for failure to achieve SVR12 will be summarized.
次要结局
- The proportion of subjects in the PP population experiencing virological failure (either on-treatment or post-treatment relapse by 12 weeks post treatment) will be estimated and presented with 95% CIs.
- The proportion of subjects in the PP population achieving SVR24 will be analyzed using the same method as SVR12.
研究者
Atea Clinical Trial Information
Scientific
Atea Pharmaceuticals Inc.
研究点 (12)
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