Clinical trial NCT05904470: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Virus
Hepatitis C, Chronic
Hepatitis C
Hepatic Cirrhosis
HCV
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects experiencing treatment-emergent adverse events
timeFrame: Day 1 through 4 weeks after end of treatment
measure: Proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12)
timeFrame: 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 outcomes:
measure: Proportion of subjects experiencing virologic failure
timeFrame: Day 1 thru 12 weeks after end of treatment
measure: Proportion of subjects achieving sustained virologic response at 24 weeks post-treatment (SVR24)
timeFrame: Day 1 thru 24 weeks after end of treatment
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Atea Study Site
state: Texas
city: Manaus
country: Brazil
facility: Atea Study Site
state: Amazonas
city: Salvador
country: Brazil
facility: Atea Study Site
state: Bahia
city: Brasília
country: Brazil
facility: Atea Study Site
state: Distrito Federal
city: Rio De Janeiro
country: Brazil
facility: Atea Study Site
state: Rio do Janeiro
city: Porto Alegre
country: Brazil
facility: Atea Study Site
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Atea Study Site
state: Rio Grande do Sul
city: Porto Velho
country: Brazil
facility: Atea Study Site
state: Rondonia
city: Boa Vista
country: Brazil
facility: Atea Study Site
state: Roraima
city: Botucatu
country: Brazil
facility: Atea Study Site
state: Sao Paulo
city: Ijuí
country: Brazil
facility: Atea Study Site
state: Sao Paulo
city: Sorocaba
country: Brazil
facility: Atea Study Site
state: Sao Paulo
city: São José Do Rio Preto
country: Brazil
facility: Atea Study Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Atea Study Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Atea Study Site
state: Sao Paulo
city: Vancouver
country: Canada
facility: Atea Study Site
state: British Columbia
city: Toronto
country: Canada
facility: Atea Study Site
state: Ontario
city: Rājkot
country: India
facility: Atea Study Site
state: Gujarat
city: Sūrat
country: India
facility: Atea Study Site
state: Gujarat
city: Belgaum
country: India
facility: Atea Study Site
state: Karnataka
city: Nagpur
country: India
facility: Atea Study Site
state: Maharashtra
city: Kolkata
country: India
facility: Atea Study Site
state: West Bengal
city: Seoul
country: Korea, Republic of
facility: Atea Study Site
state: Gyeonggi
city: Yangsan
country: Korea, Republic of
facility: Atea Study Site
state: Gyeongsangnam
city: Busan
country: Korea, Republic of
facility: Atea Study Site
city: Busan
country: Korea, Republic of
facility: Atea Study Site
city: Seoul
country: Korea, Republic of
facility: Atea Study Site
city: Seoul
country: Korea, Republic of
facility: Atea Study Site
city: Quatre Bornes
country: Mauritius
facility: Atea Study Site
city: Chisinau
country: Moldova, Republic of
facility: Atea Study Site
city: Karachi
country: Pakistan
facility: Atea Study Site
city: Karachi
country: Pakistan
facility: Atea Study Site
city: Baguio
country: Philippines
facility: Atea Study Site
city: Iloilo City
country: Philippines
facility: Atea Study Site
city: Mabalacat
country: Philippines
facility: Atea Study Site
city: Bucuresti
country: Romania
facility: Atea Study Site
state: BUC
city: Bucuresti
country: Romania
facility: Atea Study Site
state: BUC
city: Constanţa
country: Romania
facility: Atea Study Site
state: CON
city: Craiova
country: Romania
facility: Atea Study Site
state: DOL
city: Bucuresti
country: Romania
facility: Atea Study Site
city: Bloemfontein
country: South Africa
facility: Atea Study Site
state: Free State
city: Johannesburg
country: South Africa
facility: Atea Study Site
state: Gauteng
city: Randburg
country: South Africa
facility: Atea Study Site
state: Gauteng
city: Somerset West
country: South Africa
facility: Atea Study Site
state: Western Cap
city: Adana
country: Turkey
facility: Atea Study Site
city: Ankara
country: Turkey
facility: Atea Study Site
city: Ankara
country: Turkey
facility: Atea Study Site
city: Ankara
country: Turkey
facility: Atea Study Site
city: Denizli
country: Turkey
facility: Atea Study Site
city: İzmir
country: Turkey
facility: Atea Study Site
city: Kayseri
country: Turkey
facility: Atea Study Site
Study officials:
References: