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

March 15, 2024 updated by: Atea Pharmaceuticals, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

280

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Amazonas
      • Manaus, Amazonas, Brazil, 69040-000
        • Recruiting
        • Atea Study Site
    • Rio Do Janeiro
      • Rio De Janeiro, Rio Do Janeiro, Brazil, 04037-030
        • Recruiting
        • Atea Study Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
        • Recruiting
        • Atea Study Site
    • Rondonia
      • Porto Velho, Rondonia, Brazil, 78918-791
        • Recruiting
        • Atea Study Site
    • Roraima
      • Boa Vista, Roraima, Brazil, 69304-015
        • Recruiting
        • Atea Study Site
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-970
        • Recruiting
        • Atea Study Site
      • Ijuí, Sao Paulo, Brazil, 98700-000
        • Recruiting
        • Atea Study Site
      • Sorocaba, Sao Paulo, Brazil, 18052-210
        • Recruiting
        • Atea Study Site
      • São José Do Rio Preto, Sao Paulo, Brazil, 15090-000
        • Recruiting
        • Atea Study Site
      • São Paulo, Sao Paulo, Brazil, 05403-000
        • Recruiting
        • Atea Study Site
      • São Paulo, Sao Paulo, Brazil, 04119-001
        • Recruiting
        • Atea Study Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Recruiting
        • Atea Study Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Atea Study Site
  • India
    • Gujarat
      • Rājkot, Gujarat, India, 360005
        • Recruiting
        • Atea Study Site
      • Sūrat, Gujarat, India, 395002
        • Recruiting
        • Atea Study Site
    • Karnataka
      • Belgaum, Karnataka, India, 590010
        • Recruiting
        • Atea Study Site
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Recruiting
        • Atea Study Site
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Recruiting
        • Atea Study Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 47392
        • Recruiting
        • Atea Study Site
      • Busan, Korea, Republic of, 49241
        • Recruiting
        • Atea Study Site
      • Seoul, Korea, Republic of, 5505
        • Recruiting
        • Atea Study Site
      • Seoul, Korea, Republic of, 6351
        • Recruiting
        • Atea Study Site
    • Gyeonggi
      • Seoul, Gyeonggi, Korea, Republic of, 120-752
        • Recruiting
        • Atea Study Site
    • Gyeongsangnam
      • Yangsan, Gyeongsangnam, Korea, Republic of, 626-770
        • Recruiting
        • Atea Study Site
  • Mauritius
      • Quatre Bornes, Mauritius, 72218
        • Recruiting
        • Atea Study Site
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, 2025
        • Recruiting
        • Atea Study Site
  • Pakistan
      • Karachi, Pakistan, 74800
        • Recruiting
        • Atea Study Site
      • Karachi, Pakistan, 75600
        • Recruiting
        • Atea Study Site
  • Philippines
      • Iloilo City, Philippines, 5000
        • Recruiting
        • Atea Study Site
      • Mabalacat, Philippines, 2023
        • Recruiting
        • Atea Study Site
  • Romania
      • Bucuresti, Romania, 21105
        • Recruiting
        • Atea Study Site
    • BUC
      • Bucuresti, BUC, Romania, 022328
        • Recruiting
        • Atea Study Site
      • Bucuresti, BUC, Romania, 30303
        • Recruiting
        • Atea Study Site
    • CON
      • Constanţa, CON, Romania, 900709
        • Recruiting
        • Atea Study Site
    • DOL
      • Craiova, DOL, Romania, 200073
        • Recruiting
        • Atea Study Site
  • South Africa
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Recruiting
        • Atea Study Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Recruiting
        • Atea Study Site
      • Randburg, Gauteng, South Africa, 2087
        • Recruiting
        • Atea Study Site
    • Western Cap
      • Somerset West, Western Cap, South Africa, 7130
        • Recruiting
        • Atea Study Site
  • Turkey
      • Ankara, Turkey, 6230
        • Recruiting
        • Atea Study Site
      • Ankara, Turkey, 6800
        • Recruiting
        • Atea Study Site
      • Ankara, Turkey, 6100
        • Recruiting
        • Atea Study Site
      • Denizli, Turkey, 20070
        • Recruiting
        • Atea Study Site
      • Kayseri, Turkey, 38010
        • Recruiting
        • Atea Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bemnifosbuvir and Ruzasvir

Bemnifosbuvir (BEM; AT-527) Tablets

Ruzasvir (RZR; AT-038) Capsules
Drug: Bemnifosbuvir
550 mg administered orally once a day (QD) for 8 weeks
Other Names:
  • AT-527
Drug: Ruzasvir
180 mg administered orally once a day (QD) for 8 weeks
Other Names:
  • AT-038

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects experiencing treatment-emergent adverse events
Time Frame: Day 1 through 4 weeks after end of treatment
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
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 Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects experiencing virologic failure
Time Frame: Day 1 thru 12 weeks after end of treatment
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
Day 1 thru 24 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atea Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-01B-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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