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A Phase 2, Safety and Efficac...

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

Last Updated: 2025-10-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2025-01-28

Brief Summary

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

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Detailed Description

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Conditions

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Chronic Hepatitis C Virus Hepatitis C, Chronic Hepatitis C Hepatic Cirrhosis HCV

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bemnifosbuvir and Ruzasvir

Bemnifosbuvir (BEM; AT-527) Tablets

Ruzasvir (RZR; AT-038) Capsules

Group Type EXPERIMENTAL

Bemnifosbuvir

Intervention Type DRUG

550 mg administered orally once a day (QD) for 8 weeks

Ruzasvir

Intervention Type DRUG

180 mg administered orally once a day (QD) for 8 weeks

Interventions

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Bemnifosbuvir

550 mg administered orally once a day (QD) for 8 weeks

Intervention Type DRUG

Ruzasvir

180 mg administered orally once a day (QD) for 8 weeks

Intervention Type DRUG

Other Intervention Names

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AT-527 AT-038

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers