Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
880
Countries
6
Sites
38
Chronic Hepatitis C Virus (HCV) Infection
To evaluate the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD.
Key facts
- Sponsor
- Atea Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 2 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Atea Pharmaceuticals, Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Pharmacokinetic, Efficacy
To evaluate the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD.
Secondary objectives 1
- To evaluate the effect of RASs in NS5A and/or NS5B on the efficacy of BEM/RZR FDC administered for 8 or 12 weeks QD versus SOF/VEL administered for 12 weeks QD
Conditions and MedDRA coding
Chronic Hepatitis C Virus (HCV) Infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10008912 | Chronic hepatitis C | 100000004862 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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-1RNA level < LLOQ 2. Suitable ARV treatment and not taking any contraindicated medications.
Exclusion criteria 8
- 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.
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.
Secondary endpoints 2
- Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs.
- Proportion of subjects experiencing virologic failure.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Bemnifosbuvir/Ruzasvir Fixed Dose Combination (FDC)
PRD12154491 · Product
- Active substance
- Ruzasvir
- Substance synonyms
- MK-8408
- Other product name
- BEM/RZR FDC
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ATEA PHARMACEUTICALS, INC
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
PRD13006359 · Product
- Active substance
- Sofosbuvir
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ATEA PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Atea Pharmaceuticals Inc.
- Sponsor organisation
- Atea Pharmaceuticals Inc.
- Address
- 225 Franklin Street Suite 2100
- City
- Boston
- Postcode
- 02110-2856
- Country
- United States
Scientific contact point
- Organisation
- Atea Pharmaceuticals Inc.
- Contact name
- Atea Clinical Trial Information
Public contact point
- Organisation
- Atea Pharmaceuticals Inc.
- Contact name
- Atea Clinical Trial Information
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Other |
| IQVIA RDS Hellas Single Member S.A. ORG-100048380
|
Chalandri, Greece | Other |
| Quipment ORG-100043496
|
Nancy, France | Other |
| Ceeri Clinical Research S.R.L. ORG-100046995
|
Bucharest, Romania | Other |
| Almac Clinical Services Limited ORG-100017464
|
Craigavon, United Kingdom (Northern Ireland) | Code 14 |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 13, Other, Code 2, Code 5, Data management, Code 8 |
| DDL Diagnostic Laboratory B.V. ORG-100046406
|
Rijswijk Zh, Netherlands | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Yprime LLC ORG-100042888
|
Malvern, United States | Interactive response technologies (IRT) |
Locations
6 EU/EEA countries · 38 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 50 | 6 |
| Germany | Ongoing, recruitment ended | 25 | 4 |
| Greece | Ongoing, recruitment ended | 25 | 6 |
| Poland | Ongoing, recruitment ended | 50 | 8 |
| Romania | Ongoing, recruitment ended | 100 | 10 |
| Spain | Ongoing, recruitment ended | 25 | 4 |
| Rest of world
South Africa, Pakistan, India, Thailand, Moldova, Republic of, Turkey, Korea, Republic of, Egypt, Malaysia, Vietnam
|
— | 605 | — |
Investigational sites
Les Hopitaux Universitaires De Strasbourg
Hepato-gastroenterology and endoscopy, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Centre Hospitalier Universitaire De Montpellier
Hepato-gastroenterology, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
University Hospital Of Clermont-Ferrand
Digestive and Hepatobiliary Medicine, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Assistance Publique Hopitaux De Paris
Hepatology, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Hopital Beaujon
Hepatology, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire De Nice
Hepato-Gastro-enterology and Digestive Oncology, 151 Route De Saint Antoine, 06200, Nice
Goethe University Frankfurt
Medizinische Klinik I, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
University Medical Center Hamburg-Eppendorf
Zentrum für Innere Medizin I, Martinistrasse 52, Eppendorf, Hamburg
Eugastro GmbH
na, Johannisplatz 1, Zentrum Sudost, Leipzig
Medizinische Hochschule Hannover
Gastroenterologie, Hepatologie, Infektiologie, Endokrinologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
University General Hospital Of Alexandroupoli
1st Department of Internal Medicine, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
General Hospital of Rhodes Andreas Papandreou
1st Department of Internal Medicine, Christian Barnard 1, 85133, Rhodes
Hippokration Hospital
2nd Department of Internal Medicine - National and Kapodistrian University of Athens, Vassilissas Sofias Avenue 114, 115 27, Athens
Laiko General Hospital Of Athens
First Department of Internal Medicine, Agiou Thoma (goudi) 17, 115 27, Athens
Evangelismos S.A.
3rd Department of Internal Medicine, Ipsiladou 45-47, 106 76, Athens
University General Hospital Of Heraklion
Gastroenterology Department, Stavrakia And Voutes, 715 00, Heraklion
Centrum Medyczne W Lancucie Sp. z o.o.
Poradnia Chorób Zakaźnych, Ul. Ignacego Paderewskiego 5, 37-100, Lancut
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
N/A, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw
5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
N/A, ul. Wrocławska 1-3, 30-901, Cracow
Globe Badania Kliniczne Sp. z o.o.
N/A, Ul. Janusza Kusocinskiego 3a, 57-300, Klodzko
Gyncentrum Sp. z o.o.
N/A, Rondo Organizacji Narodow Zjednoczonych 1, 00-124, Warsaw
ID Clinic
N/A, Ul. Janowska 19, 41-400, Myslowice
Medrise Sp. z o.o.
N/A, Ul. Onyksowa 10, 20-582, Lublin
Med Polonia Sp. z o.o.
N/A, Obornicka 262, 60-693, Poznan
Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
Infectious and Tropical Diseases Adults V Department, Soseaua Mihai Bravu Nr 281 Sector 3, 030303, Bucharest
Institutul Clinic Fundeni
Department of Internal Medicine II, Soseaua Fundeni 258, 022328, Bucharest
Spitalul Clinic Judetean De Urgenta Sibiu
Infectious Disease, Bulevardul Coposu Corneliu 2-4, 550245, Sibiu
Centrul Medical Renasterea S.R.L.
Infectious Disease Department, Strada Doljului No 35, 200073, Craiova
Spitalul Clinic De Boli Infectioase Constanta
Infectious Disease Department, Bulevardul Ferdinand 100, 900709, Constanta
Clinic Hospital For Infectious Diseases Sf. Cuvioasa Parascheva Galati
Infectious Diseases Clinic Section I, Traian Street No 393, 800179, Galati
Spitalul Clinic Colentina Bucuresti
Gastroenterology Department, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Infectious Disease, 149th Ic Bratianu Street, 077015, Balotesti
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
Infectious Diseases Department, Bulevardul 1 Decembrie 1918 21, 720237, Suceava
Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi
Department of Infectious Diseases III, Strada Botez Octav Nr 2, 700116, Jassi
Hospital Universitario Marques De Valdecilla
Gastroenterology and Hepatology, Avenida Valdecilla Sn, 39008, Santander
Hospital Povisa S.A.
Internal Medicine Service, Rua Salamanca 5, 36211, Vigo
Hospital Universitario Virgen De La Victoria
Gastroenterology and Hepatology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Universitari Vall D Hebron
Liver Unit, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-10-02 | 2025-11-04 | 2026-05-21 | ||
| Germany | 2025-10-22 | 2025-11-05 | 2026-05-20 | ||
| Greece | 2025-12-04 | 2025-12-17 | 2026-05-20 | ||
| Poland | 2025-10-10 | 2025-10-17 | 2026-05-20 | ||
| Romania | 2025-10-06 | 2025-10-13 | 2026-05-20 | ||
| Spain | 2025-11-13 | 2025-12-15 | 2026-05-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 60 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_EL_2025-521096-31-00_Red | 3.0 Am2 |
| Protocol (for publication) | D1_Protocol_EN_2025-521096-31-00_Red | 3.0 Am 2 |
| Recruitment arrangements (for publication) | K1_2025-521096-31-00_Recruitment and consent | V1.0FRA1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment and Informed consent procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_san | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K2_2025-521096-31-00_Recruitment tools_Banner Ads | NA |
| Recruitment arrangements (for publication) | K2_2025-521096-31-00_Recruitment tools_Dr-to-Patient Letter_red | V03FRAfr01 |
| Recruitment arrangements (for publication) | K2_2025-521096-31-00_Recruitment tools_Patient Advocacy Group Letter_red | V02FRAfr01 |
| Recruitment arrangements (for publication) | K2_2025-521096-31-00_Recruitment tools_Patient Brochure_red | V03FRAfr |
| Recruitment arrangements (for publication) | K2_2025-521096-31-00_Recruitment tools_Patient Poster_red | V01FRAfr |
| Recruitment arrangements (for publication) | K2_2025-521096-31-00_Recruitment tools_Social Media Clinical Trial Posts_red | V01FRAfr |
| Recruitment arrangements (for publication) | K2_Banner ads | 01 |
| Recruitment arrangements (for publication) | K2_Banner Ads_san | NA |
| Recruitment arrangements (for publication) | K2_Dr to Patient Letter_Redacted | 02 |
| Recruitment arrangements (for publication) | K2_Dr-to-Patient Letter_red-san | V03DEU(de) |
| Recruitment arrangements (for publication) | K2_Patient Advocacy Group Letter_red-san | V02DEU(de) |
| Recruitment arrangements (for publication) | K2_Patient Advocacy Group Letter_Redacted | 02 |
| Recruitment arrangements (for publication) | K2_Patient Brochure_red-san | V03DEU(de) |
| Recruitment arrangements (for publication) | K2_Patient Brochure_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Patient Poster_red-san | V01DEU(de) |
| Recruitment arrangements (for publication) | K2_Patient Poster_Redacted | 01 |
| Recruitment arrangements (for publication) | K2_Recruitment material_C-FORWARD_Banner Ads_ES | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_C-FORWARD_Dr-to-Patient Letter_V03ESV1_28Apr2025_Redacted | V03ESV1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_C-FORWARD_Patient Advocacy Group Letter_ES_V2ESPV1_28Apr2025_Redacted | V2ESPV1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_C-FORWARD_Patient Brochure_ES_V3_4Apr2025_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_C-FORWARD_Patient Poster_ES_V1_4Mar2025_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_C-FORWARD_Social Media and Clinical Trial Posts_ES_V1_10Mar2025_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr-to-Patient Letter_red | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr-to-Patient Letter_red | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_red | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Brochure_red | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_red | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Poster_red | 1.0 |
| Recruitment arrangements (for publication) | K2_Social Media_Clinical Trial Posts_red-san | V01DEU(de) |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main_Redacted | V2.0ESP2.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Partner_Redacted | 1.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_2025-521096-31-00_ICF_Main_red | V2.0FRA2.1 |
| Subject information and informed consent form (for publication) | L1_2025-521096-31-00_ICF_Pregnancy_red | V1.0FRA1.1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_red-san | V2.0DEU2.0 |
| Subject information and informed consent form (for publication) | L1_Pregnancy Follow-up ICF_red-san | V1.0DEU2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_EN_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_GR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_Sis and ICF_Main ICF_EN_red | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_red | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_red | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner and pregnant participant ICF_EN_red | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner and pregnant participant ICF_red | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner and pregnant participant ICF_red | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SOF_VEL placeholder | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EL_2025-521096-31-00 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2025-521096-31-00 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2025-521096-31-00 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2025-521096-31-00 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2025-521096-31-00 | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2025-521096-31-00 | NA |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-22 | Germany | Acceptable 2025-09-05
|
2025-09-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-25 | Germany | Acceptable 2025-09-05
|
2025-09-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-30 | Germany | Acceptable 2025-11-27
|
2025-11-28 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-15 | Germany | Acceptable 2025-11-27
|
2025-12-15 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-21 | Germany | Acceptable 2025-11-27
|
2026-01-21 |