Clinical trial • Phase II • Infectious Disease
BEPIROVIRSEN for Chronic hepatitis B
Phase II trial of BEPIROVIRSEN for Chronic hepatitis B. open-label, none/not specified-controlled. 270 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Chronic hepatitis B
- Trial Stage
- Phase II
- Drug Modality
- Oligonucleotide
Key dates
- Initial CTIS Submission Date
- 07-02-2024
- First CTIS Authorization Date
- 28-02-2024
Trial design
open-label, none/not specified-controlled Phase II trial in Italy, Romania, Poland and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 270
Eligibility
Recruits 270 Vulnerable population selected. Inclusion requires participants to be "Capable of giving informed consent". No paediatric/assent provisions are described in the available criteria..
- Vulnerable Population
- Vulnerable population selected. Inclusion requires participants to be "Capable of giving informed consent". No paediatric/assent provisions are described in the available criteria.
Inclusion criteria
- {"criterion_text":"- 1. Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule\n- 2. Capable of giving informed consent\n- 209668 (B-Clear), 209348 (B-Together) and 212602 (B-Fine) participants: 3. Participants who have previously received at least 1 dose of bepirovirsen AND a. Achieved a complete response in the parent study and who maintained a response for 24 weeks until the EoS visit in their parent study, in the absence of rescue medication (defined as complete responders to bepirovirsen from the parent study) OR b. Demonstrated HBsAg reduction from parent study Baseline with HBsAg levels and HBV DNA for 24 weeks after the actual end of treatment regimen, in the absence of rescue medication and maintained until their EoS visit in the parent study.\n- 202009 and 219288 (B-Well 1 & 2) participants: 4. Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where approrpiate) AND a.\tNA cessated at Week 48 in parent study and achieved HBsAg and HBV DNA, in the absence of rescue medication at the EOS visit (Week 96) in the parent study OR b.\tAchieved NA cessation criteria at Week 48 in parent study but have not stopped NA treatment, and are maintaining HBsAg and HBV DNA at EOS visit (Week 72) of parent study OR c.\tDid not achieve NA cessation criteria in parent study, but achieved HBsAg and HBV DNA at EOS visit (Week 72) of parent study\n- 217023 (TH HBV ASO-001) participants: 5. Participants who have previously received at least 1 dose of bepirovirsen AND achieved HBsAg and HBV DNA at the EOS study visit in parent study"}
Exclusion criteria
- {"criterion_text":"- 1. Participants who have participated in / are currently participating in another interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.\n- 2. Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participant in this study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- For 209668 (B-Clear; not-on-NA): Time from achieving FC, to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication.","definition_or_measurement_approach":"Time-to-event measured from achievement of functional cure (FC) to first occurrence of HBsAg or HBV DNA reversion, or to first use of any rescue medication."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA)and 217023 (TH HBV ASO-001; on-NA): Time from achieving FC (24 weeks post NA cessation) to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication","definition_or_measurement_approach":"Time-to-event measured from achievement of FC (defined as 24 weeks post NA cessation for on-NA participants) to first HBsAg or HBV DNA reversion or first use of any rescue medication."}
- {"endpoint_text":"- For 202009 and 219288 (B-Well 1 & 2; NAcessated): Time from achieving FC (including delayed FC) in the parent study to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication.","definition_or_measurement_approach":"Time-to-event measured from FC (including delayed FC) achieved in parent study to first HBsAg or HBV DNA reversion or first use of any rescue medication."}
Secondary endpoints
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): • Time from NA cessation to the first occurrence of HBsAg reversion or first use of any rescue medication","definition_or_measurement_approach":"Time from NA cessation to first HBsAg reversion or first use of rescue medication."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication","definition_or_measurement_approach":"Time from NA cessation to first virologic relapse or first use of rescue medication."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication","definition_or_measurement_approach":"Time from NA cessation to first clinical relapse or first use of rescue medication."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first use of rescue medication","definition_or_measurement_approach":"Time from NA cessation to first use of rescue medication."}
- {"endpoint_text":"- For 202009 and 219288 (B-Well 1 & 2; NAcessated): Time from NA cessation to the first occurrence of HBsAg reversion or first use of any rescue medication. Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication.","definition_or_measurement_approach":"For NA-cessated B-Well participants: time from NA cessation to HBsAg reversion or virologic relapse or first use of rescue medication."}
- {"endpoint_text":"- For 202009 and 219288 (B-Well 1 & 2; NAcessated): Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication. Time from NA cessation to first use of any rescue medication.","definition_or_measurement_approach":"For NA-cessated B-Well participants: time from NA cessation to clinical relapse and to first use of rescue medication."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA): • Time from achieving complete response in the previous bepirovirsen treatment study, to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication","definition_or_measurement_approach":"Time from complete response in parent study to first HBsAg or HBV DNA reversion or first use of rescue medication."}
- {"endpoint_text":"- 202009 and 219288 (B-Well 1 & 2; On-NA) and 217023 (TH HBV ASO-001; on-NA): •Time from HBsAg and HBV DNA , to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication.","definition_or_measurement_approach":"Time from achieving HBsAg and HBV DNA criteria to first HBsAg/HBV DNA reversion or first use of rescue medication."}
- {"endpoint_text":"- For 209668 (B-Clear; not-on-NA) partial responders: a. Time from end of treatment in the parent study to delayed FC. b. For participants who go on to achieve delayed FC: Time from achieving delayed FC to loss of FC.","definition_or_measurement_approach":"a) Time from end of parent-study treatment to delayed functional cure. b) For those achieving delayed FC, time from achieving delayed FC to loss of FC."}
- {"endpoint_text":"- For 202009 and 219288 (B-Well 1 & 2; NA-cessated) partial responders: a. Time from NA cessation to delayed FC. b. For participants who go on to achieve delayed FC: Time from achieving delayed FC to loss of FC.","definition_or_measurement_approach":"For NA-cessated B-Well partial responders: time from NA cessation to delayed FC, and time from delayed FC to loss of FC."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1&2; on-NA), and 217023 (TH HBV ASO-001; on-NA): a. Time from NA cessation in B-Sure to delayed FC in B-Sure. b. For participants who achieve delayed FC in B-Sure: Time from achieving delayed FC to loss of FC.","definition_or_measurement_approach":"a) Time from NA cessation in B-Sure to delayed FC in B-Sure. b) For participants with delayed FC in B-Sure: time from delayed FC to loss of FC."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1&2; on-NA): a.Time from end of treatment in the parent study to delayed complete response. b. For participants who achieve a delayed complete response: Time from achieving delayed complete response to loss of response.","definition_or_measurement_approach":"a) Time from end of parent-study treatment to delayed complete response. b) Time from delayed complete response to loss of response."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to HBsAg loss in the absence of any rescue medication.","definition_or_measurement_approach":"Time from NA cessation to HBsAg loss without use of rescue medication."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication.","definition_or_measurement_approach":"Time from NA cessation to first virologic relapse or first use of rescue medication."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication","definition_or_measurement_approach":"Time from NA cessation to first clinical relapse or first use of rescue medication."}
- {"endpoint_text":"- For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to the first use of rescue medication.","definition_or_measurement_approach":"Time from NA cessation to first use of rescue medication."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 270
- Recruitment Window Months
- 85
- Consent Approach
- Informed consent must be provided by participants who are "Capable of giving informed consent". Subject Information Sheets and Informed Consent Forms (L1 SIS and ICF) are available in multiple country/language versions (examples in the dossier: EN, BG, RO, FR, ES, IT, PL, GR, HU). Consent is obtained at site level as per the provided ICF documents.
Methods
- GP letters (documented K2/G P Letter materials referenced in recruitment documents)
- Patient brochures and patient newsletters (country-specific K1 recruitment arrangements and patient brochure documents)
- Flipcharts / recruitment flipchart materials (K2 recruitment material flipchart)
- Patient participation cards
- PatientGO app (PatientGO App materials described in recruitment documents)
- ePROs and subject visit reminders (Medable listed with duty: ePROs and subject visit reminders)
- Off-site research nursing (Illingworth Research Group Limited duty: Off-site research nursing including lab sample collection/processing)
Geography
- Total Number Of Sites
- 59
- Total Number Of Participants
- 108
Italy
- Earliest CTIS Part Ii Submission Date
- 20-02-2024
- Latest Decision Or Authorization Date
- 04-09-2025
- Processing Time Days
- 562
- Number Of Sites
- 9
- Number Of Participants
- 13
Sites
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- INFECTIOUS DISEASES
- Principal Investigator Name
- Nicola Coppola
- Principal Investigator Email
- nicola.coppola@unicampania.it
- Contact Person Name
- Nicola Coppola
- Contact Person Email
- nicola.coppola@unicampania.it
- Site Name
- Azienda Ospedaliero Universitaria Di Modena
- Department Name
- Struttura Complessa di Medicina ad Indirizzo Metabolico Nutrizionale
- Principal Investigator Name
- Pietro Andreone
- Principal Investigator Email
- pietro.andreone@unimore.it
- Contact Person Name
- Pietro Andreone
- Contact Person Email
- pietro.andreone@unimore.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Gastroenterology and Hepatology Division
- Principal Investigator Name
- Pietro Lampertico
- Principal Investigator Email
- Pietro.lampertico@unimi.it
- Contact Person Name
- Pietro Lampertico
- Contact Person Email
- Pietro.lampertico@unimi.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- SC Malattie Infettive
- Principal Investigator Name
- Francesco Castelli
- Principal Investigator Email
- castelli@med.unibs.it
- Contact Person Name
- Francesco Castelli
- Contact Person Email
- castelli@med.unibs.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- SC Gastroenterologia U
- Principal Investigator Name
- Alessia Ciancio
- Principal Investigator Email
- alessia.ciancio@unito.it
- Contact Person Name
- Alessia Ciancio
- Contact Person Email
- alessia.ciancio@unito.it
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- UOC Gastroenterologia
- Principal Investigator Name
- Vito Di Marco
- Principal Investigator Email
- vito.dimarco@unipa.it
- Contact Person Name
- Vito Di Marco
- Contact Person Email
- vito.dimarco@unipa.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Dipartimento di Medicina, SC di Gastroenterologia 1 Epatologia Trapiantologia
- Principal Investigator Name
- Stefano Fagiuoli
- Principal Investigator Email
- sfagiuoli@asst-pg23.it
- Contact Person Name
- Stefano Fagiuoli
- Contact Person Email
- sfagiuoli@asst-pg23.it
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Maria Vittoria Cossu
- Principal Investigator Email
- maria.cossu@asst-fbf-sacco.it
- Contact Person Name
- Maria Vittoria Cossu
- Contact Person Email
- maria.cossu@asst-fbf-sacco.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Epatologia
- Principal Investigator Name
- Maurizia Brunetto
- Principal Investigator Email
- maurizia.brunetto@unipi.it
- Contact Person Name
- Maurizia Brunetto
- Contact Person Email
- maurizia.brunetto@unipi.it
Romania
- Earliest CTIS Part Ii Submission Date
- 20-02-2024
- Latest Decision Or Authorization Date
- 05-08-2025
- Processing Time Days
- 532
- Number Of Sites
- 8
- Number Of Participants
- 14
Sites
- Site Name
- Institutul National De Boli Infectioase Prof.Dr.Matei Bals
- Department Name
- Sectia Clinica II Boli Infectioase Adulti
- Principal Investigator Name
- Liliana Preotescu
- Principal Investigator Email
- preolil17@yahoo.com
- Contact Person Name
- Liliana Preotescu
- Contact Person Email
- preolil17@yahoo.com
- Site Name
- Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova
- Department Name
- Clinica de Boli Infectioase Adulti II
- Principal Investigator Name
- Gheorghe Diaconescu
- Principal Investigator Email
- diaconescu_ig@yahoo.com
- Contact Person Name
- Gheorghe Diaconescu
- Contact Person Email
- diaconescu_ig@yahoo.com
- Site Name
- Clinic Hospital For Infectious Diseases Sf. Cuvioasa Parascheva Galati
- Department Name
- Infectious Diseases Clinic Section I
- Principal Investigator Name
- Manuela Arbune
- Principal Investigator Email
- arbunemanuela@yahoo.com
- Contact Person Name
- Manuela Arbune
- Contact Person Email
- arbunemanuela@yahoo.com
- Site Name
- Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi
- Department Name
- Sectia I
- Principal Investigator Name
- Andrei Vata
- Principal Investigator Email
- andreiandrei@yahoo.com
- Contact Person Name
- Andrei Vata
- Contact Person Email
- andreiandrei@yahoo.com
- Site Name
- Institutul National De Boli Infectioase Prof.Dr.Matei Bals
- Principal Investigator Name
- Anca Streinu-Cercel
- Principal Investigator Email
- anca.streinucercel@gmail.com
- Contact Person Name
- Anca Streinu-Cercel
- Contact Person Email
- anca.streinucercel@gmail.com
- Site Name
- Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
- Department Name
- Boli Infecțioase si tropicale
- Principal Investigator Name
- Corneliu Popescu
- Principal Investigator Email
- cornel160@yahoo.com
- Contact Person Name
- Corneliu Popescu
- Contact Person Email
- cornel160@yahoo.com
- Site Name
- Spitalul Clinic Colentina Bucuresti
- Department Name
- Gastroenterologie
- Principal Investigator Name
- Radu Bogdan Mateescu
- Principal Investigator Email
- bogmateescu@gmail.com
- Contact Person Name
- Radu Bogdan Mateescu
- Contact Person Email
- bogmateescu@gmail.com
- Site Name
- Pelican Impex S.R.L.
- Department Name
- Gastroenterologie
- Principal Investigator Name
- Alin-Horea Suta
- Principal Investigator Email
- assdr26@yahoo.com
- Contact Person Name
- Alin-Horea Suta
- Contact Person Email
- assdr26@yahoo.com
Poland
- Earliest CTIS Part Ii Submission Date
- 20-02-2024
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 714
- Number Of Sites
- 5
- Number Of Participants
- 13
Sites
- Site Name
- Punkt Zdrowia Hlebowicz Jakubowski Lekarze sp. p.
- Principal Investigator Name
- Maria Hlebowicz
- Principal Investigator Email
- kontakt@punktlekarze.pl
- Contact Person Name
- Maria Hlebowicz
- Contact Person Email
- kontakt@punktlekarze.pl
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Hepatology Department
- Principal Investigator Name
- Ewa Przybylo
- Principal Investigator Email
- e.przybylo@szpitaljp2.krakow.pl
- Contact Person Name
- Ewa Przybylo
- Contact Person Email
- e.przybylo@szpitaljp2.krakow.pl
- Site Name
- HEPID Diagnostyka i Terapia
- Principal Investigator Name
- Krzysztof Tomasiewicz
- Principal Investigator Email
- krzysztof.tomasiewicz@umlub.pl
- Contact Person Name
- Krzysztof Tomasiewicz
- Contact Person Email
- krzysztof.tomasiewicz@umlub.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
- Site Name
- Centrum Medyczne W Lancucie Sp. z o.o.
- Principal Investigator Name
- Robert Pleśniak
- Principal Investigator Email
- Robert.plesniak@wp.pl
- Contact Person Name
- Robert Pleśniak
- Contact Person Email
- Robert.plesniak@wp.pl
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 20-02-2024
- Latest Decision Or Authorization Date
- 04-08-2025
- Processing Time Days
- 531
- Number Of Sites
- 6
- Number Of Participants
- 15
Sites
- Site Name
- Military Medical Academy
- Department Name
- Gastroenterology Clinic
- Principal Investigator Name
- Krum Katsarov
- Principal Investigator Email
- krumkatzarov@yahoo.com
- Contact Person Name
- Krum Katsarov
- Contact Person Email
- krumkatzarov@yahoo.com
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Gastroenterology Clinic
- Principal Investigator Name
- Dragomir Gerov
- Principal Investigator Email
- dr.dragomir.gerov@gmail.com
- Contact Person Name
- Dragomir Gerov
- Contact Person Email
- dr.dragomir.gerov@gmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment Sofiamed OOD
- Department Name
- Clinic of Internal Medicine
- Principal Investigator Name
- Nevin Idriz
- Principal Investigator Email
- nevin_idriz@abv.bg
- Contact Person Name
- Nevin Idriz
- Contact Person Email
- nevin_idriz@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment Hadji Dimitar OOD
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Dimitar Pavlov
- Principal Investigator Email
- md.pavlov@mail.bg
- Contact Person Name
- Dimitar Pavlov
- Contact Person Email
- md.pavlov@mail.bg
- Site Name
- Diagnostics-Consultancy Center Mladost M Varna OOD
- Principal Investigator Name
- Iskren Kotsev
- Principal Investigator Email
- kotzev@mnet.bg
- Contact Person Name
- Iskren Kotsev
- Contact Person Email
- kotzev@mnet.bg
- Site Name
- Diagnostic-Consultative Center Alexandrovska EOOD
- Principal Investigator Name
- Diana Petrova
- Principal Investigator Email
- prof.petrova@mail.bg
- Contact Person Name
- Diana Petrova
- Contact Person Email
- prof.petrova@mail.bg
Greece
- Earliest CTIS Part Ii Submission Date
- 20-02-2024
- Latest Decision Or Authorization Date
- 05-08-2025
- Processing Time Days
- 532
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Hippokration Hospital
- Department Name
- 2nd University Internal Medicine Clinic/ Hepogastrenterology Unit
- 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
- Evaggelismos Hospital
- Department Name
- 3rd Internal Medicine Department
- Principal Investigator Name
- Vasileios Sevastianos
- Principal Investigator Email
- vsevastianos@gmail.com
- Contact Person Name
- Vasileios Sevastianos
- Contact Person Email
- vsevastianos@gmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- 1st 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
Hungary
- Earliest CTIS Part Ii Submission Date
- 20-02-2024
- Latest Decision Or Authorization Date
- 01-08-2025
- Processing Time Days
- 528
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- Infektologia - Felnott rendelo
- Principal Investigator Name
- Mihaly Makara
- Principal Investigator Email
- makara.mihaly@mdd.hu
- Contact Person Name
- Mihaly Makara
- Contact Person Email
- makara.mihaly@mdd.hu
France
- Earliest CTIS Part Ii Submission Date
- 24-10-2024
- Latest Decision Or Authorization Date
- 31-07-2025
- Processing Time Days
- 280
- Number Of Sites
- 7
- Number Of Participants
- 14
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d hepatologie
- 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
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Service Hepato-gastroenterologie
- Principal Investigator Name
- Isabelle ROSA
- Principal Investigator Email
- isabelle.rosa@chicreteil.fr
- Contact Person Name
- Isabelle ROSA
- Contact Person Email
- isabelle.rosa@chicreteil.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service d hepatologie et gastroenterologie
- Principal Investigator Name
- Fabien ZOULIM
- Principal Investigator Email
- fabien.zoulim@chu-lyon.fr
- Contact Person Name
- Fabien ZOULIM
- Contact Person Email
- fabien.zoulim@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service Hepato-gastro-enterologie
- Principal Investigator Name
- Juliette FOUCHER
- Principal Investigator Email
- juliette.foucher@chu-bordeaux.fr
- Contact Person Name
- Juliette FOUCHER
- Contact Person Email
- juliette.foucher@chu-bordeaux.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Liver Disease department
- Principal Investigator Name
- Caroline JEZEQUEL
- Principal Investigator Email
- caroline.jezequel@chu-rennes.fr
- Contact Person Name
- Caroline JEZEQUEL
- Contact Person Email
- caroline.jezequel@chu-rennes.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service Hepato-gastro-enterologie
- Principal Investigator Name
- Vlad RATZIU
- Principal Investigator Email
- vlad.ratziu@inserm.fr
- Contact Person Name
- Vlad RATZIU
- Contact Person Email
- vlad.ratziu@inserm.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service Hepato-gastro-enterologie
- 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
Germany
- Earliest CTIS Part Ii Submission Date
- 21-02-2025
- Latest Decision Or Authorization Date
- 08-08-2025
- Processing Time Days
- 168
- Number Of Sites
- 6
- Number Of Participants
- 11
Sites
- Site Name
- Infektiologisches Zentrum Steglitz (IZS)
- Principal Investigator Name
- Gordon Weinberg
- Principal Investigator Email
- weinberg@infektiologie-steglitz.de
- Contact Person Name
- Gordon Weinberg
- Contact Person Email
- weinberg@infektiologie-steglitz.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik fuer Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie
- Principal Investigator Name
- Heiner Wedemeyer
- Principal Investigator Email
- wedemeyer.heiner@mh-hannover.de
- Contact Person Name
- Heiner Wedemeyer
- Contact Person Email
- wedemeyer.heiner@mh-hannover.de
- Site Name
- Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH
- Principal Investigator Name
- Hartmut Stocker
- Principal Investigator Email
- stocker@epimed.org
- Contact Person Name
- Hartmut Stocker
- Contact Person Email
- stocker@epimed.org
- Site Name
- Praxis MainFachArzt
- Department Name
- HIV- und infektiologische Schwerpunktpraxis
- Principal Investigator Name
- Pavel Khaykin
- Principal Investigator Email
- khaykin@mainfacharzt.de
- Contact Person Name
- Pavel Khaykin
- Contact Person Email
- khaykin@mainfacharzt.de
- Site Name
- ICH Study Center GmbH & Co. KG
- Department Name
- Rotherbaum
- Principal Investigator Name
- Michael Sabranski
- Principal Investigator Email
- sabranski@ich-studycenter.com
- Contact Person Name
- Michael Sabranski
- Contact Person Email
- sabranski@ich-studycenter.com
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik fuer Gastroenterologie, Hepatologie und Infektiologie
- Principal Investigator Name
- Hans Bock
- Principal Investigator Email
- hans.bock@med.uni-duesseldorf.de
- Contact Person Name
- Hans Bock
- Contact Person Email
- hans.bock@med.uni-duesseldorf.de
Spain
- Earliest CTIS Part Ii Submission Date
- 20-02-2024
- Latest Decision Or Authorization Date
- 23-04-2026
- Processing Time Days
- 793
- Number Of Sites
- 13
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Gastroenterology
- Principal Investigator Name
- Luisa Consuelo Garcia Buey
- Principal Investigator Email
- luisaconsuelo.garcia@salud.madrid.org
- Contact Person Name
- Luisa Consuelo Garcia Buey
- Contact Person Email
- luisaconsuelo.garcia@salud.madrid.org
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Internal Medicine
- Principal Investigator Name
- Moncef Belhassen Garcia
- Principal Investigator Email
- mbelhassen@saludcastillayleon.es
- Contact Person Name
- Moncef Belhassen Garcia
- Contact Person Email
- mbelhassen@saludcastillayleon.es
- Site Name
- Complexo Hospitalario Universitario De Pontevedra
- Department Name
- Hepathology
- Principal Investigator Name
- Juan Turnes Vazquez
- Principal Investigator Email
- juan.turnes.vazquez@sergas.es
- Contact Person Name
- Juan Turnes Vazquez
- Contact Person Email
- juan.turnes.vazquez@sergas.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Javier Ampuero Herrojo
- Principal Investigator Email
- javi.ampuero@gmail.com
- Contact Person Name
- Javier Ampuero Herrojo
- Contact Person Email
- javi.ampuero@gmail.com
- Site Name
- Hospital Universitario De Leon
- Department Name
- Digestive
- Principal Investigator Name
- Francisco Jorquera Plaza
- Principal Investigator Email
- fjorqueraplaza@gmail.com
- Contact Person Name
- Francisco Jorquera Plaza
- Contact Person Email
- fjorqueraplaza@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Digestive Medicine - Hepatology
- Principal Investigator Name
- Maria Garcia Eliz
- Principal Investigator Email
- magarel@yahoo.es
- Contact Person Name
- Maria Garcia Eliz
- Contact Person Email
- magarel@yahoo.es
- Site Name
- Consorcio Hospital General Universitario De Valencia
- Department Name
- Digestive
- Principal Investigator Name
- Juan Jose Urquijo Ponce
- Principal Investigator Email
- juanjo.urquijo@gmail.com
- Contact Person Name
- Juan Jose Urquijo Ponce
- Contact Person Email
- juanjo.urquijo@gmail.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Gastroenterology Service
- Principal Investigator Name
- Inmaculada Fernandez Vazquez
- Principal Investigator Email
- ifvazquez@salud.madrid.org
- Contact Person Name
- Inmaculada Fernandez Vazquez
- Contact Person Email
- ifvazquez@salud.madrid.org
- Site Name
- Parc Tauli Hospital Universitari
- Department Name
- Gastroenterology
- Principal Investigator Name
- Mireia Miquel Planas
- Principal Investigator Email
- mmiquel@tauli.cat
- Contact Person Name
- Mireia Miquel Planas
- Contact Person Email
- mmiquel@tauli.cat
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Digestive Department
- Principal Investigator Name
- Joaquín Cabezas Gonzalez
- Principal Investigator Email
- joweycabezas@gmail.com
- Contact Person Name
- Joaquín Cabezas Gonzalez
- Contact Person Email
- joweycabezas@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Digestive and Liver Diseases
- Principal Investigator Name
- Maria Buti Ferret
- Principal Investigator Email
- mbuti@vhebron.net
- Contact Person Name
- Maria Buti Ferret
- Contact Person Email
- mbuti@vhebron.net
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- Internal Medicine
- Principal Investigator Name
- Pablo Ryan Murua
- Principal Investigator Email
- pabloryan@gmail.com
- Contact Person Name
- Pablo Ryan Murua
- Contact Person Email
- pabloryan@gmail.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hepatology
- Principal Investigator Name
- Zoe Marino Mendez
- Principal Investigator Email
- zmarino@clinic.cat
- Contact Person Name
- Zoe Marino Mendez
- Contact Person Email
- zmarino@clinic.cat
Sponsor
Primary sponsor
- Full Name
- Glaxosmithkline Research & Development Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Contract research organisations
- Name
- Pharmaceutical Product Development LLC
- Responsibilities
- Immunology Tests (sponsorDuties include code 15 and 4)
- Name
- Parexel International Corp.
- Responsibilities
- CRO activities listed (sponsorDuties code 10) — specific responsibilities not fully detailed in extract
- Name
- Syneos Health Hellas Single Member S.A.
- Responsibilities
- Operational support including activities mapped to sponsorDuties codes 1,12,7,8
- Name
- Syneos Health Netherlands B.V.
- Responsibilities
- Operational support including activities mapped to sponsorDuties codes 1,12,7,8
- Name
- Medable Inc.
- Responsibilities
- ePROs and subject visit reminders
Third parties
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Immunology Tests (sponsorDuties codes: 15 and 4 listed)","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Off-site research nursing (including lab samples collection + processing as part of Off Site Visits) (sponsorDuties code: 15)","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Sponsor duties listed (code 10) — specific role not detailed in extract","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Syneos Health Hellas Single Member S.A.","duties_or_roles":"Multiple operational duties (sponsorDuties codes: 1, 12, 7, 8) as listed","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medable Inc.","duties_or_roles":"ePROs and subject visit reminders","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Multiple operational duties (sponsorDuties codes: 1, 12, 7, 8) as listed","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BEPIROVIRSEN (SOLUTION FOR INJECTION)
- Active Substance
- BEPIROVIRSEN
- Modality
- Oligonucleotide
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS
- Authorisation Status
- Authorised (prodAuthStatus=1)
Related trials
Other published trials that may interest you.