A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV

Completed · Phase 2

Conditions studied: Chronic Hepatitis C Virus, Hepatitis C, Chronic, Hepatitis C, Hepatic Cirrhosis, HCV

In brief

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

Key facts

Study ID

NCT05904470

Run by

Atea Pharmaceuticals, Inc.

People needed

275

Starts

2023-05-30

Expected to finish

2025-01-28

Last updated by the study team

2025-10-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Atea Study Site — Manaus, Amazonas, Brazil
• Atea Study Site — Salvador, Estado de Bahia, Brazil
• Atea Study Site — Brasília, Federal District, Brazil
• Atea Study Site — Rio de Janeiro, Rio Do Janeiro, Brazil
• Atea Study Site — Porto Alegre, Rio Grande do Sul, Brazil
• Atea Study Site — Porto Alegre, Rio Grande do Sul, Brazil
• Atea Study Site — Porto Velho, Rondônia, Brazil
• Atea Study Site — Boa Vista, Roraima, Brazil
• Atea Study Site — Botucatu, São Paulo, Brazil
• Atea Study Site — Ijuí, São Paulo, Brazil
• Atea Study Site — São José do Rio Preto, São Paulo, Brazil
• Atea Study Site — São Paulo, São Paulo, Brazil
• Atea Study Site — São Paulo, São Paulo, Brazil
• Atea Study Site — Sorocaba, São Paulo, Brazil
• Atea Study Site — Vancouver, British Columbia, Canada
• Atea Study Site — Toronto, Ontario, Canada
• Atea Study Site — Rajkot, Gujarat, India
• Atea Study Site — Surat, Gujarat, India
• Atea Study Site — Belagavi, Karnataka, India
• Atea Study Site — Nagpur, Maharashtra, India
• Atea Study Site — Kolkata, West Bengal, India
• Atea Study Site — Quatre Bornes, Mauritius
• Atea Study Site — Chisinau, Moldova
• Atea Study Site — Karachi, Pakistan
• Atea Study Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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