CTIS2023-504566-28-00招募中1 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 - AT-01B-004
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 249
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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
研究者
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