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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904470
• Other study ID #: AT-01B-004
• Status: Recruiting
• Phase: Phase 2
• Start date: May 30, 2023
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Atea Pharmaceuticals, Inc.
• Contact: Clinical Trials Administrator
• Phone: 1(857)284-8891
• Email: ateaclinicaltrials[@]ateapharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis C Virus
• HCV
• Hepatic Cirrhosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis

Intervention

Drug:
• Bemnifosbuvir
550 mg administered orally once a day (QD) for 8 weeks
• Ruzasvir
180 mg administered orally once a day (QD) for 8 weeks

Locations

Country	Name	City	State
Brazil	Atea Study Site	Boa Vista	Roraima
Brazil	Atea Study Site	Botucatu	Sao Paulo
Brazil	Atea Study Site	Brasília	Distrito Federal
Brazil	Atea Study Site	Ijuí	Sao Paulo
Brazil	Atea Study Site	Manaus	Amazonas
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	Rondonia
Brazil	Atea Study Site	Rio De Janeiro	Rio Do Janeiro
Brazil	Atea Study Site	Salvador	Bahia
Brazil	Atea Study Site	São José Do Rio Preto	Sao Paulo
Brazil	Atea Study Site	São Paulo	Sao Paulo
Brazil	Atea Study Site	São Paulo	Sao Paulo
Brazil	Atea Study Site	Sorocaba	Sao Paulo
Canada	Atea Study Site	Toronto	Ontario
Canada	Atea Study Site	Vancouver	British Columbia
India	Atea Study Site	Belgaum	Karnataka
India	Atea Study Site	Kolkata	West Bengal
India	Atea Study Site	Nagpur	Maharashtra
India	Atea Study Site	Rajkot	Gujarat
India	Atea Study Site	Surat	Gujarat
Korea, Republic of	Atea Study Site	Busan
Korea, Republic of	Atea Study Site	Busan
Korea, Republic of	Atea Study Site	Seoul
Korea, Republic of	Atea Study Site	Seoul
Korea, Republic of	Atea Study Site	Seoul	Gyeonggi
Korea, Republic of	Atea Study Site	Yangsan	Gyeongsangnam
Mauritius	Atea Study Site	Quatre Bornes
Moldova, Republic of	Atea Study Site	Chisinau
Pakistan	Atea Study Site	Karachi
Pakistan	Atea Study Site	Karachi
Philippines	Atea Study Site	Baguio
Philippines	Atea Study Site	Iloilo City
Philippines	Atea Study Site	Mabalacat
Romania	Atea Study Site	Bucuresti	BUC
Romania	Atea Study Site	Bucuresti	BUC
Romania	Atea Study Site	Bucuresti
Romania	Atea Study Site	Constanta	CON
Romania	Atea Study Site	Craiova	DOL
South Africa	Atea Study Site	Bloemfontein	Free State
South Africa	Atea Study Site	Johannesburg	Gauteng
South Africa	Atea Study Site	Randburg	Gauteng
South Africa	Atea Study Site	Somerset West	Western Cap
Turkey	Atea Study Site	Adana
Turkey	Atea Study Site	Ankara
Turkey	Atea Study Site	Ankara
Turkey	Atea Study Site	Ankara
Turkey	Atea Study Site	Denizli
Turkey	Atea Study Site	Izmir
Turkey	Atea Study Site	Kayseri
United States	Atea Study Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Brazil,  Canada,  India,  Korea, Republic of,  Mauritius,  Moldova, Republic of,  Pakistan,  Philippines,  Romania,  South Africa,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects experiencing treatment-emergent adverse events		Day 1 through 4 weeks after end of treatment
Primary	Proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12)		Day 1 through12 weeks after end of treatment ] SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment
Secondary	Proportion of subjects experiencing virologic failure		Day 1 thru 12 weeks after end of treatment
Secondary	Proportion of subjects achieving sustained virologic response at 24 weeks post-treatment (SVR24)		Day 1 thru 24 weeks after end of treatment