Clinical trial • Phase III • Infectious Disease
RUZASVIR, BEMNIFOSBUVIR for Chronic hepatitis C
Phase III trial of RUZASVIR, BEMNIFOSBUVIR for Chronic hepatitis C.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Chronic hepatitis C
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 22-05-2025
- First CTIS Authorization Date
- 08-09-2025
Trial design
Randomised, open-label, sofosbuvir / velpatasvir (oral tablet) as comparator; administered once daily (qd) for 12 weeks (dose not specified in ctis record). test arm: bemnifosbuvir/ruzasvir fdc (oral tablet) administered once daily (qd) for 8 or 12 weeks (dose not specified).-controlled Phase III trial across 37 sites in Greece, Spain, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Sofosbuvir / Velpatasvir (oral tablet) as comparator; administered once daily (QD) for 12 weeks (dose not specified in CTIS record). Test arm: Bemnifosbuvir/Ruzasvir FDC (oral tablet) administered once daily (QD) for 8 or 12 weeks (dose not specified).
- Target Sample Size
- 605
- Trial Duration For Participant
- 168
Eligibility
Recruits 605 No vulnerable population selected in the CTIS record. Standard informed consent from adult participants is required; no assent or paediatric consent processes are described..
- Pregnancy Exclusion
- Pregnant or breastfeeding.
- Vulnerable Population
- No vulnerable population selected in the CTIS record. Standard informed consent from adult participants is required; no assent or paediatric consent processes are described.
Inclusion criteria
- {"criterion_text":"- Use of adequate contraception for females of childbearing potential.\n- Must be direct-acting antiviral (DAA)-treatment naïve (never exposed to an approved or experimental DAA for HCV).\n- Documented medical history compatible with chronic HCV.\n- Either no liver cirrhosis or with compensated liver cirrhosis.\n- 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
- {"criterion_text":"- Pregnant or breastfeeding.\n- Co-infected with hepatitis B virus.\n- Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator.\n- Requirement of any prohibited medications.\n- Use of other investigational drugs within 30 days of dosing.\n- History or signs of decompensated liver disease (decompensated cirrhosis).\n- History of hepatocellular carcinoma (HCC).\n- 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 endpoints
- {"endpoint_text":"- Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.","definition_or_measurement_approach":"HCV RNA measured and assessed as less than the lower limit of quantitation (LLOQ) at study week 24."}
Secondary endpoints
- {"endpoint_text":"- Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs.","definition_or_measurement_approach":"HCV RNA measured and assessed as < LLOQ at 12 weeks after the last dose of study drugs."}
- {"endpoint_text":"- Proportion of subjects experiencing virologic failure.","definition_or_measurement_approach":"Occurrence of virologic failure as assessed by the study (no further definition provided in the CTIS record)."}
Recruitment
- Registry Or Advocacy Recruitment
- True — Patient Advocacy Group Letter (country-specific versions) is included in recruitment materials (no specific advocacy organisation names provided).
- Digital Remote Recruitment
- True — Social Media Clinical Trial Posts and Banner Ads are included as recruitment channels (country/language-specific materials present).
- Planned Sample Size
- 605
- Recruitment Window Months
- 17
- Consent Approach
- Informed consent obtained using L1 SIS and ICF Main subject information and informed consent forms. ICFs are available in multiple language versions (English, Greek, French, Spanish, Polish, Romanian, German as indicated by document titles). Separate pregnancy/pregnant-partner ICFs are provided. Consent is from adult participants; no paediatric assent processes are described.
Methods
- Dr-to-Patient Letter (physician-mediated invitation) — country-specific versions referenced (e.g. German, Spanish, French, Romanian, Polish, Greek versions listed in recruitment documents).
- Patient Poster — printed/poster materials for patients (country/language-specific versions referenced).
- Patient Brochure — informational brochure for potential participants (country/language-specific versions referenced).
- Patient Advocacy Group Letter — outreach to patient advocacy groups (country/language-specific versions referenced).
- Banner Ads — digital display advertisements (documents titled Banner Ads present).
- Social Media and Clinical Trial Posts — digital/social media recruitment posts (country/language-specific versions present).
Geography
- Total Number Of Sites
- 37
- Total Number Of Participants
- 275
Greece
- Earliest CTIS Part Ii Submission Date
- 21-08-2025
- Latest Decision Or Authorization Date
- 16-09-2025
- Processing Time Days
- 26
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- General Hospital of Rhodes Andreas Papandreou
- Department Name
- 1st Department of Internal Medicine
- Principal Investigator Name
- Stylianos Karatapanis
- Principal Investigator Email
- karstyl56@gmail.com
- Contact Person Name
- Stylianos Karatapanis
- Contact Person Email
- karstyl56@gmail.com
- Site Name
- Evangelismos S.A.
- Department Name
- 3rd Department of Internal Medicine
- Principal Investigator Name
- Vasileios Sevastianos
- Principal Investigator Email
- vsevastianos@gmail.com
- Contact Person Name
- Vasileios Sevastianos
- Contact Person Email
- vsevastianos@gmail.com
- Site Name
- Hippokration Hospital
- Department Name
- 2nd Department of Internal Medicine - National and Kapodistrian University of Athens
- Principal Investigator Name
- Spilios Manolakopoulos
- Principal Investigator Email
- smanolak@med.uoa.gr
- Contact Person Name
- Spilios Manolakopoulos
- Contact Person Email
- smanolak@med.uoa.gr
- Site Name
- University General Hospital Of Alexandroupoli
- Department Name
- 1st Department of Internal Medicine
- Principal Investigator Name
- Konstantinos Mimidis
- Principal Investigator Email
- kostasmimidis@hotmail.com
- Contact Person Name
- Konstantinos Mimidis
- Contact Person Email
- kostasmimidis@hotmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- First Department of Internal Medicine
- Principal Investigator Name
- Evangelos Cholongitas
- Principal Investigator Email
- cholongitas@yahoo.gr
- Contact Person Name
- Evangelos Cholongitas
- Contact Person Email
- cholongitas@yahoo.gr
- Site Name
- University General Hospital Of Heraklion
- Department Name
- Gastroenterology Department
- Principal Investigator Name
- Ioannis Koutroubakis
- Principal Investigator Email
- Ikoutroub2@gmail.com
- Contact Person Name
- Ioannis Koutroubakis
- Contact Person Email
- Ikoutroub2@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 18-08-2025
- Latest Decision Or Authorization Date
- 09-09-2025
- Processing Time Days
- 22
- Number Of Sites
- 4
- Number Of Participants
- 25
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Liver Unit
- Principal Investigator Name
- Maria Buti Ferret
- Principal Investigator Email
- mariabutiferret@gmail.com
- Contact Person Name
- Maria Buti Ferret
- Contact Person Email
- mariabutiferret@gmail.com
- Site Name
- Hospital Povisa S.A.
- Department Name
- Internal Medicine Service
- Principal Investigator Name
- Javier De la Fuente Aguado
- Principal Investigator Email
- jfuente@povisa.es
- Contact Person Name
- Javier De la Fuente Aguado
- Contact Person Email
- jfuente@povisa.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Raúl Jesús Andrade Bellido
- Principal Investigator Email
- andrade@uma.es
- Contact Person Name
- Raúl Jesús Andrade Bellido
- Contact Person Email
- andrade@uma.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Joaquin Cabezas Gonzalez
- Principal Investigator Email
- joaquin.cabezas@scsalud.es
- Contact Person Name
- Joaquin Cabezas Gonzalez
- Contact Person Email
- joaquin.cabezas@scsalud.es
Poland
- Earliest CTIS Part Ii Submission Date
- 14-08-2025
- Latest Decision Or Authorization Date
- 19-09-2025
- Processing Time Days
- 36
- Number Of Sites
- 8
- Number Of Participants
- 50
Sites
- Site Name
- Med Polonia Sp. z o.o.
- Principal Investigator Name
- Katarzyna Hryckiewicz
- Principal Investigator Email
- katarzynkahr@wp.pl
- Contact Person Name
- Katarzyna Hryckiewicz
- Contact Person Email
- katarzynkahr@wp.pl
- Site Name
- Gyncentrum Sp. z o.o.
- Principal Investigator Name
- Aleksandra Korczyńska
- Principal Investigator Email
- korola@op.pl
- Contact Person Name
- Aleksandra Korczyńska
- Contact Person Email
- korola@op.pl
- Site Name
- Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
- Principal Investigator Name
- Monika Pazgan-Simon
- Principal Investigator Email
- monikapazgansimon@gmail.com
- Contact Person Name
- Monika Pazgan-Simon
- Contact Person Email
- monikapazgansimon@gmail.com
- Site Name
- Medrise Sp. z o.o.
- Principal Investigator Name
- Joanna Krzowska-Firych
- Principal Investigator Email
- firychjdr@poczta.onet.pl
- Contact Person Name
- Joanna Krzowska-Firych
- Contact Person Email
- firychjdr@poczta.onet.pl
- Site Name
- Globe Badania Kliniczne Sp. z o.o.
- Principal Investigator Name
- Diana Rotar
- Principal Investigator Email
- diana.rotar@globebadania.pl
- Contact Person Name
- Diana Rotar
- Contact Person Email
- diana.rotar@globebadania.pl
- Site Name
- 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
- Principal Investigator Name
- Jakub Loster
- Principal Investigator Email
- kuba.loster@gmail.com
- Contact Person Name
- Jakub Loster
- Contact Person Email
- kuba.loster@gmail.com
- Site Name
- Centrum Medyczne W Lancucie Sp. z o.o.
- Department Name
- Poradnia Chorób Zakaźnych
- Principal Investigator Name
- Robert Pleśniak
- Principal Investigator Email
- robert.plesniak@wp.pl
- Contact Person Name
- Robert Pleśniak
- Contact Person Email
- robert.plesniak@wp.pl
- Site Name
- ID Clinic
- Principal Investigator Name
- Ewa Janczewska
- Principal Investigator Email
- e.janczewska@poczta.fm
- Contact Person Name
- Ewa Janczewska
- Contact Person Email
- e.janczewska@poczta.fm
France
- Earliest CTIS Part Ii Submission Date
- 22-07-2025
- Latest Decision Or Authorization Date
- 10-09-2025
- Processing Time Days
- 50
- Number Of Sites
- 6
- Number Of Participants
- 50
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hepato-gastroenterology
- Principal Investigator Name
- Magdalena MESZAROS
- Principal Investigator Email
- m-meszaros@chu-montpellier.fr
- Contact Person Name
- Magdalena MESZAROS
- Contact Person Email
- m-meszaros@chu-montpellier.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Digestive and Hepatobiliary Medicine
- Principal Investigator Name
- Armando ABERGEL
- Principal Investigator Email
- aabergel@chu-clermontferrand.fr
- Contact Person Name
- Armando ABERGEL
- Contact Person Email
- aabergel@chu-clermontferrand.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Hepato-Gastro-enterology and Digestive Oncology
- Principal Investigator Name
- Albert TRAN
- Principal Investigator Email
- tran.a@chu-nice.fr
- Contact Person Name
- Albert TRAN
- Contact Person Email
- tran.a@chu-nice.fr
- Site Name
- Hopital Beaujon
- Department Name
- Hepatology
- Principal Investigator Name
- Tarik ASSELAH
- Principal Investigator Email
- tarik.asselah@aphp.fr
- Contact Person Name
- Tarik ASSELAH
- Contact Person Email
- tarik.asselah@aphp.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Hepato-gastroenterology and endoscopy
- Principal Investigator Name
- Francois HABERSETZER
- Principal Investigator Email
- Francois.Habersetzer@chru-strasbourg.fr
- Contact Person Name
- Francois HABERSETZER
- Contact Person Email
- Francois.Habersetzer@chru-strasbourg.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hepatology
- Principal Investigator Name
- Vincent LEROY
- Principal Investigator Email
- vincent.leroy2@aphp.fr
- Contact Person Name
- Vincent LEROY
- Contact Person Email
- vincent.leroy2@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 16-06-2025
- Latest Decision Or Authorization Date
- 08-09-2025
- Processing Time Days
- 84
- Number Of Sites
- 4
- Number Of Participants
- 25
Sites
- Site Name
- Eugastro GmbH
- Principal Investigator Name
- Ingolf Schiefke
- Principal Investigator Email
- ingolf.schiefke@eugastro.de
- Contact Person Name
- Ingolf Schiefke
- Contact Person Email
- ingolf.schiefke@eugastro.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Gastroenterologie, Hepatologie, Infektiologie, Endokrinologie
- Principal Investigator Name
- Katja Deterding
- Principal Investigator Email
- deterding.katja@mh-hannover.de
- Contact Person Name
- Katja Deterding
- Contact Person Email
- deterding.katja@mh-hannover.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Medizinische Klinik I
- Principal Investigator Name
- Kathrin Andrea Sprinzl
- Principal Investigator Email
- kathrin.sprinzl@unimedizin-ffm.de
- Contact Person Name
- Kathrin Andrea Sprinzl
- Contact Person Email
- kathrin.sprinzl@unimedizin-ffm.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Zentrum für Innere Medizin I
- Principal Investigator Name
- Julian Schulze zur Wiesch
- Principal Investigator Email
- j.schulze-zur-wiesch@uke.de
- Contact Person Name
- Julian Schulze zur Wiesch
- Contact Person Email
- j.schulze-zur-wiesch@uke.de
Sponsor
Primary sponsor
- Full Name
- Atea Pharmaceuticals Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Altasciences Compagnie Inc.
- Responsibilities
- PK analysis
- Name
- IQVIA RDS Hellas Single Member S.A.
- Responsibilities
- on-site monitoring, investigator recruitment, safety reporting, regulatory expertise for Greece
- Name
- IQVIA Limited
- Responsibilities
- on-site monitoring, investigator recruitment, safety reporting, regulatory expertise, patient documents development, and other trial support
- Name
- Ceeri Clinical Research S.R.L.
- Responsibilities
- On site monitoring, Project management , regulatory expertise for Romania and Poland
- Name
- Almac Clinical Services Limited
- Responsibilities
- clinical services (unspecified duties)
Third parties
- {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"PK analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"on-site monitoring, investigator recruitment, safety reporting, regulatory expertise for Greece","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Quipment","duties_or_roles":"Equipment provider","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Romania","full_name":"Ceeri Clinical Research S.R.L.","duties_or_roles":"On site monitoring, Project management , regulatory expertise for Romania and Poland","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"unspecified duties (code 14)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"multiple duties including on-site monitoring, investigator recruitment, safety reporting, regulatory support, patient documents development, and others (codes 1,2,4,5,6,8,12,13,15)","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"DDL Diagnostic Laboratory B.V.","duties_or_roles":"laboratory services (code 4)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sample management; laboratory services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"electronic data capture/clinical trial systems (code 7)","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"data/privacy vendor (code 3)","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Bemnifosbuvir/Ruzasvir Fixed Dose Combination (FDC)
- Active Substance
- RUZASVIR, BEMNIFOSBUVIR
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorisation status code 1
- Frequency
- Once daily (QD); treatment duration 8 or 12 weeks
- Investigational Product Name
- Sofosbuvir / Velpatasvir
- Active Substance
- SOFOSBUVIR, VELPATASVIR
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorisation status code 1
- Frequency
- Once daily (QD); treatment duration 12 weeks (comparator)
- Combination Treatment
- Yes
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