C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV

NCT ID: NCT07037277

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2027-03-31

Brief Summary

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The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.

Detailed Description

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Conditions

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HEPATITIS C VIRUS CHRONIC INFECTION Hepatitis C, Chronic Hepatitis C Virus Infection Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bemnifosbuvir - Ruzasvir (BEM/RZR)

Group Type EXPERIMENTAL

Bemnifosbuvir-Ruzasvir

Intervention Type DRUG

BEM/RZR Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 8 weeks (in those without cirrhosis) or 12 weeks (in those with compensated cirrhosis)

Sofosbuvir-Velpatasvir (SOF/VEL)

Group Type ACTIVE_COMPARATOR

Sofosbuvir-Velpatasvir

Intervention Type DRUG

SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks

Interventions

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Bemnifosbuvir-Ruzasvir

BEM/RZR Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 8 weeks (in those without cirrhosis) or 12 weeks (in those with compensated cirrhosis)

Intervention Type DRUG

Sofosbuvir-Velpatasvir

SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks

Intervention Type DRUG

Other Intervention Names

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(BEM/RZR) (SOF/VEL)

Eligibility Criteria

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Inclusion Criteria

* Use of adequate contraception for females of childbearing potential
* Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV)
* Documented medical history compatible with chronic HCV
* Either no liver cirrhosis or with compensated liver cirrhosis
* If HIV-1-positive, must meet the following 2 criteria:

1. Antiretroviral (ARV) regimen for \>8 weeks prior to screening visit, with CD4 T-cell count \>200 cells/mm3 and plasma HIV-1 RNA \<LLOQ
2. Suitable ARV treatment and not taking any contraindicated medications

Exclusion Criteria

* Pregnant or breastfeeding
* Co-infected with hepatitis B virus
* 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
* Requirement of any prohibited medications
* Use of other investigational drugs within 30 days of dosing
* History or signs of decompensated liver disease (decompensated cirrhosis)
* History of hepatocellular carcinoma (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

No

Sponsors

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Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atea Study Site

Nice, Alpes Maritimes, France

Site Status RECRUITING

Atea Study Site

Strasbourg, Bas Rhin, France

Site Status RECRUITING

Atea Study Site

Clichy, Hauts de Seine, France

Site Status RECRUITING

Atea Study Site

Montpellier, Herault, France

Site Status RECRUITING

Atea Study Site

Clermont-Ferrand, Puy de Dome, France

Site Status RECRUITING

Atea Study Site

Créteil, Val de Marne, France

Site Status RECRUITING

Atea Study Site

Hamburg, Hamburg, Germany

Site Status RECRUITING

Atea Study Site

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Atea Study Site

Leipzig, Saxony, Germany

Site Status RECRUITING

Atea Study Site

Alexandroupoli, , Greece

Site Status RECRUITING

Atea Study Site

Athens, , Greece

Site Status RECRUITING

Atea Study Site

Athens, , Greece

Site Status RECRUITING

Atea Study Site

Heraklion, , Greece

Site Status RECRUITING

Atea Study Site

Hyderabad, Andhra Pradesh, India

Site Status RECRUITING

Atea Study Site

Patna, Bihar, India

Site Status RECRUITING

Atea Study Site

Rajkot, Gujarat, India

Site Status RECRUITING

Atea Study Site

Surat, Gujarat, India

Site Status RECRUITING

Atea Study Site

Shimla, Himachal Pradesh, India

Site Status RECRUITING

Atea Study Site

Belagavi, Karnataka, India

Site Status RECRUITING

Atea Study Site

Kochi, Kerala, India

Site Status RECRUITING

Atea Study Site

Mumbai, Maharashtra, India

Site Status RECRUITING

Atea Study Site

Nagpur, Maharashtra, India

Site Status RECRUITING

Atea Study Site

Pune, Maharashtra, India

Site Status RECRUITING

Atea Study Site

Pune, Maharashtra, India

Site Status RECRUITING

Atea Study Site

Ludhiana, Punjab, India

Site Status RECRUITING

Atea Study Site

Agra, Uttar Pradesh, India

Site Status RECRUITING

Atea Study Site

Kanpur, Uttar Pradesh, India

Site Status RECRUITING

Atea Study Site

Lucknow, Uttar Pradesh, India

Site Status RECRUITING

Atea Study Site

Varanasi, Uttar Pradesh, India

Site Status RECRUITING

Atea Study Site

Kolkata, West Bengal, India

Site Status RECRUITING

Atea Study Site

Kota Bharu, Kelantan, Malaysia

Site Status RECRUITING

Atea Study Site

Kota Bharu, Kelantan, Malaysia

Site Status RECRUITING

Atea Study Site

Ampang, Kuala Lumpur, Malaysia

Site Status RECRUITING

Atea Study Site

Kuala Lumpur, Kuala Lumpur, Malaysia

Site Status RECRUITING

Atea Study Site

Kuantan, Pahang, Malaysia

Site Status RECRUITING

Atea Study Site

Kota Kinabalu, Sabah, Malaysia

Site Status RECRUITING

Atea Clinical Study Site

Chisinau, , Moldova

Site Status RECRUITING

Atea Study Site

Islamabad, , Pakistan

Site Status RECRUITING

Atea Study Site

Islamabad, , Pakistan

Site Status RECRUITING

Atea Study Site

Karachi, , Pakistan

Site Status RECRUITING

Atea Study Site

Karachi, , Pakistan

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Atea Study Site

Karachi, , Pakistan

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Atea Study Site

Karachi, , Pakistan

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Atea Study Site

Lahore, , Pakistan

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Atea Study Site

Lahore, , Pakistan

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Atea Study Site

Lahore, , Pakistan

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Atea Study Site

Peshawar, , Pakistan

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Atea Study Site

Rawalpindi, , Pakistan

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Atea Study Site

Krakow, , Poland

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Atea Study Site

Kłodzko, , Poland

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Atea Study Site

Lublin, , Poland

Site Status RECRUITING

Atea Study Site

Mysłowice, , Poland

Site Status RECRUITING

Atea Study Site

Warsaw, , Poland

Site Status RECRUITING

Atea Study Site

Wroclaw, , Poland

Site Status RECRUITING

Atea Study Site

Bucharest, , Romania

Site Status RECRUITING

Atea Study Site

Bucharest, , Romania

Site Status RECRUITING

Atea Study Site

Bucharest, , Romania

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Atea Study Site

Bucharest, , Romania

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Atea Study Site

Constanța, , Romania

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Atea Study Site

Craiova, , Romania

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Atea Study Site

Galati, , Romania

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Atea Study Site

Iași, , Romania

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Atea Study Site

Sibiu, , Romania

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Atea Study Site

Suceava, , Romania

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Atea Study Site

Port Elizabeth, Eastern Cape, South Africa

Site Status RECRUITING

Atea Study Site

Bloemfontein, Free State, South Africa

Site Status RECRUITING

Atea Study Site

Johannesburg, Gauteng, South Africa

Site Status RECRUITING

Atea Study Site

Johannesburg, Gauteng, South Africa

Site Status RECRUITING

Atea Study Site

Johannesburg, Gauteng, South Africa

Site Status RECRUITING

Atea Study Site

Pretoria, Gauteng, South Africa

Site Status RECRUITING

Atea Study Site

Brits, North West, South Africa

Site Status RECRUITING

Atea Study Site

Somerset West, Western Cape, South Africa

Site Status RECRUITING

Atea Study Site

Seoul, Gyeonggi-do, South Korea

Site Status RECRUITING

Atea Study Site

Yangsan, Gyeongsangnam-do, South Korea

Site Status RECRUITING

Atea Study Site

Busan, , South Korea

Site Status RECRUITING

Atea Study Site

Busan, , South Korea

Site Status RECRUITING

Atea Study Site

Seoul, , South Korea

Site Status RECRUITING

Atea Study Site

Barcelona, Barcelona, Spain

Site Status RECRUITING

Atea Study Site

Santander, Cantabria, Spain

Site Status RECRUITING

Atea Study Site

Málaga, Malaga, Spain

Site Status RECRUITING

Atea Study Site

Vigo, Pontevedra, Spain

Site Status RECRUITING

Atea Study Site

Bangkok, Bangkok, Thailand

Site Status RECRUITING

Atea Study Site

Pathum Wan, Bangkok, Thailand

Site Status RECRUITING

Atea Study Site

Ratchathewi, Bangkok, Thailand

Site Status RECRUITING

Atea Study Site

Mueang Nonthaburi, Changwat Khon Kaen, Thailand

Site Status RECRUITING

Atea Study Site

Hat Yai, Changwat Songkhla, Thailand

Site Status RECRUITING

Atea Study Site

Mueang Nonthaburi, Chiang Mai, Thailand

Site Status RECRUITING

Atea Study Site

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Atea Study Site

Denizli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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France Germany Greece India Malaysia Moldova Pakistan Poland Romania South Africa South Korea Spain Thailand Turkey (Türkiye)

Central Contacts

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Clinical Trials Administrator

Role: CONTACT

1-857-284-8891

Other Identifiers

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AT-01B-008

Identifier Type: -

Identifier Source: org_study_id

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