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

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ClinicalTrials.gov Identifier: NCT05904470
Recruitment Status : Recruiting
First Posted : June 15, 2023
Last Update Posted : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
Atea Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE June 6, 2023
First Posted Date  ICMJE June 15, 2023
Last Update Posted Date May 14, 2024
Actual Study Start Date  ICMJE May 30, 2023
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2023)
  • Proportion of subjects experiencing treatment-emergent adverse events [ Time Frame: Day 1 through 4 weeks after end of treatment ]
  • Proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12) [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2023)
  • Proportion of subjects experiencing virologic failure [ Time Frame: Day 1 thru 12 weeks after end of treatment ]
  • Proportion of subjects achieving sustained virologic response at 24 weeks post-treatment (SVR24) [ Time Frame: Day 1 thru 24 weeks after end of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV
Official Title  ICMJE 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
Brief Summary This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Hepatitis C Virus
  • Hepatitis C, Chronic
  • Hepatitis C
  • Hepatic Cirrhosis
  • HCV
Intervention  ICMJE
  • Drug: Bemnifosbuvir
    550 mg administered orally once a day (QD) for 8 weeks
    Other Name: AT-527
  • Drug: Ruzasvir
    180 mg administered orally once a day (QD) for 8 weeks
    Other Name: AT-038
Study Arms  ICMJE Experimental: Bemnifosbuvir and Ruzasvir

Bemnifosbuvir (BEM; AT-527) Tablets

Ruzasvir (RZR; AT-038) Capsules

Interventions:
  • Drug: Bemnifosbuvir
  • Drug: Ruzasvir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2023)		 280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 1(857)284-8891 ateaclinicaltrials@ateapharma.com
Listed Location Countries  ICMJE Brazil,   Canada,   India,   Korea, Republic of,   Mauritius,   Moldova, Republic of,   Pakistan,   Philippines,   Romania,   South Africa,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05904470
Other Study ID Numbers  ICMJE AT-01B-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Atea Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Atea Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Atea Pharmaceuticals, Inc.
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP