A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV
- Summary
- This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.
- Short title
- A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2025-01-28
- First posted
- 2023-06-15
- Registry last updated
- 2025-10-21
- Primary completion date
- 2024-12-09
- Start date
- 2023-05-30
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05904470
- ClinicalTrials.gov ID
- NCT05904470
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Percentage of Subjects Achieving Sustained Virologic Response at 12 Weeks Post-treatment (SVR12)
Timeframe: Day 1 through 12 weeks after end of treatment
SVR12 defined as plasma hepatitis C virus (HCV) RNA less than the lower limit of quantitation (\<LLOQ) at 12 weeks post-treatment
Percentage of Subjects Experiencing Virologic Failure
Timeframe: Day 1 through 12 weeks after end of treatment
Virologic failure defined as a confirmed 1 log10 increase in HCV RNA from post-baseline nadir, or confirmed increase in HCV RNA ≥ LLOQ in any subject who achieved HCV RNA \< LLOQ.
Percentage of Subjects Achieving Sustained Virologic Response at 24 Weeks Post-treatment (SVR24)
Timeframe: Day 1 through 24 weeks after end of treatment
SVR24 defined as plasma HCV RNA less than the lower limit of quantitation (\<LLOQ) at 24 weeks post-treatment
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 85 Years
- Healthy volunteers
- No
-
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)
- 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
- Atea Study SiteSan Antonio, United States
- Atea Study SiteManaus, Brazil
- Atea Study SiteSalvador, Brazil
- Atea Study SiteBrasília, Brazil
- Atea Study SiteRio de Janeiro, Brazil
- Atea Study SitePorto Alegre, Brazil
- Atea Study SitePorto Alegre, Brazil
- Atea Study SitePorto Velho, Brazil
- Atea Study SiteBoa Vista, Brazil
- Atea Study SiteBotucatu, Brazil
- Atea Study SiteIjuí, Brazil
- Atea Study SiteSão José do Rio Preto, Brazil
- Atea Study SiteSão Paulo, Brazil
- Atea Study SiteSão Paulo, Brazil
- Atea Study SiteSorocaba, Brazil
- Atea Study SiteVancouver, Canada
- Atea Study SiteToronto, Canada
- Atea Study SiteRajkot, India
- Atea Study SiteSurat, India
- Atea Study SiteBelagavi, India
- Atea Study SiteNagpur, India
- Atea Study SiteKolkata, India
- Atea Study SiteQuatre Bornes, Mauritius
- Atea Study SiteChisinau, Moldova
- Atea Study SiteKarachi, Pakistan
And 26 more, listed on the interactive page.