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

Primary Purpose

Chronic Hepatitis C Virus, Hepatitis C, Chronic, Hepatitis C

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Bemnifosbuvir
Ruzasvir
Sponsored by
Atea Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Virus

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atea Study SiteRecruiting
  • Atea Study SiteRecruiting
  • Atea Study SiteRecruiting
  • Atea Study SiteRecruiting
  • Atea Study SiteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bemnifosbuvir and Ruzasvir

Arm Description

Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules

Outcomes

Primary Outcome Measures

Proportion of subjects experiencing treatment-emergent adverse events
Proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12)

Secondary Outcome Measures

Proportion of subjects experiencing virologic failure
Proportion of subjects achieving sustained virologic response at 24 weeks post-treatment (SVR24)

Full Information

First Posted
June 6, 2023
Last Updated
August 1, 2023
Sponsor
Atea Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05904470
Brief 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atea Pharmaceuticals, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Virus, Hepatitis C, Chronic, Hepatitis C, Hepatic Cirrhosis, HCV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bemnifosbuvir and Ruzasvir
Arm Type
Experimental
Arm Description
Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules
Intervention Type
Drug
Intervention Name(s)
Bemnifosbuvir
Other Intervention Name(s)
AT-527
Intervention Description
550 mg administered orally once a day (QD) for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Ruzasvir
Other Intervention Name(s)
AT-038
Intervention Description
180 mg administered orally once a day (QD) for 8 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects experiencing treatment-emergent adverse events
Time Frame
Day 1 through 4 weeks after end of treatment
Title
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
Secondary Outcome Measure Information:
Title
Proportion of subjects experiencing virologic failure
Time Frame
Day 1 thru 12 weeks after end of treatment
Title
Proportion of subjects achieving sustained virologic response at 24 weeks post-treatment (SVR24)
Time Frame
Day 1 thru 24 weeks after end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Administrator
Phone
1(857)284-8891
Email
ateaclinicaltrials@ateapharma.com
Facility Information:
Facility Name
Atea Study Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2C7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Atea Study Site
City
Bucuresti
State/Province
BUC
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Atea Study Site
City
Bucuresti
State/Province
BUC
ZIP/Postal Code
30303
Country
Romania
Individual Site Status
Recruiting
Facility Name
Atea Study Site
City
Constanţa
State/Province
CON
ZIP/Postal Code
900709
Country
Romania
Individual Site Status
Recruiting
Facility Name
Atea Study Site
City
Craiova
State/Province
DOL
ZIP/Postal Code
200073
Country
Romania
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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