2025-521096-31-00招募中3 期
An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 275
- 试验地点
- 38
- 主要终点
- Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.
研究概览
简要总结
To evaluate the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Use of adequate contraception for females of childbearing potential.
- •Must be direct-acting antiviral (DAA)-treatment naïve (never exposed to an approved or experimental DAA for HCV).
- •Documented medical history compatible with chronic HCV.
- •Either no liver cirrhosis or with compensated liver cirrhosis.
- •If HIV-1 positive, must meet the following 2 criteria:
- •Antiretroviral (ARV) regimen for > 8 weeks prior to screening visit, with CD4 T-cell count > 200 cells/mm3 and plasma HIV-1RNA level < LLOQ
- •Suitable ARV treatment and not taking any contraindicated medications.
排除标准
- •Pregnant or breastfeeding.
- •Co-infected with hepatitis B virus.
- •Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator.
- •Requirement of any prohibited medications.
- •Use of other investigational drugs within 30 days of dosing.
- •History or signs of decompensated liver disease (decompensated cirrhosis).
- •History of hepatocellular carcinoma (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.
结局指标
主要结局
Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.
Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.
次要结局
- Proportion of subjects experiencing virologic failure.
- Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs.
研究者
Atea Clinical Trial Information
Scientific
Atea Pharmaceuticals Inc.
研究点 (38)
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