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

This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.

2023-05-30

2024-06-01

2024-09-01

Recruiting

Early phase I

280

Inclusion Criteria: * 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) Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 280, 'type': 'ESTIMATED'}}

2024-03-18