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Clinical Trials in India / NCT07037277
Active, not recruiting Phase 3

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

NCT07037277 · tracked via the Priya Life Science India tracker
Sponsor
Atea Pharmaceuticals, Inc.
Phase
Phase 3
Started
2025-06-02
Last updated
2026-06-29

Condition(s) studied

HEPATITIS C VIRUS CHRONIC INFECTIONHepatitis C, ChronicHepatitis C Virus InfectionHepatitis C

Investigational drug(s) / intervention(s)

Bemnifosbuvir-RuzasvirSofosbuvir-Velpatasvir

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)

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Key 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 Key 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

Primary outcome measure(s)

Trial sites (107)

FacilityCityRegionStatus
Atea Study Site Cairo Egypt
Atea Study Site Nice Alpes Maritimes
Atea Study Site Strasbourg Bas Rhin
Atea Study Site Clichy Hauts De Seine
Atea Study Site Montpellier Herault
Atea Study Site Clermont-Ferrand Puy De Dome
Atea Study Site Créteil Val De Marne
Atea Study Site Frankfurt am Main Hesse
Atea Study Site Leipzig Saxony
Atea Study Site Hamburg Germany
Atea Study Site Alexandroupoli Greece
Atea Study Site Athens Greece
Atea Study Site Athens Greece
Atea Study Site Heraklion Greece
Atea Study Site Rhodes Greece
Atea Study Site Hyderabad Andhra Pradesh
Atea Study Site Patna Bihar
Atea Study Site Rajkot Gujarat
Atea Study Site Surat Gujarat
Atea Study Site Shimla Himachal Pradesh
Atea Study Site Belagavi Karnataka
Atea Study Site Kochi Kerala
Atea Study Site Mumbai Maharashtra
Atea Study Site Mumbai Maharashtra
Atea Study Site Nagpur Maharashtra
Atea Study Site Pune Maharashtra
Atea Study Site Pune Maharashtra
Atea Study Site Chandigarh Punjab
Atea Study Site Ludhiana Punjab
Atea Study Site Agra Uttar Pradesh
Atea Study Site Kanpur Uttar Pradesh
Atea Study Site Lucknow Uttar Pradesh
Atea Study Site Varanasi Uttar Pradesh
Atea Study Site Kolkata West Bengal
Atea Study Site Kota Bharu Kelantan
Atea Study Site Kota Bharu Kelantan
Atea Study Site Ampang Kuala Lumpur
Atea Study Site Kuantan Pahang
Atea Study Site Kota Kinabalu Sabah
Atea Study Site Kuala Lumpur Malaysia

+ 67 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07037277 on ClinicalTrials.gov ↗ ← All trials in India