Clinical trial • Phase II • Infectious Disease | Rare Disease
ELEBSIRAN for Chronic hepatitis D (HDV) infection
Phase II trial of ELEBSIRAN for Chronic hepatitis D (HDV) infection.
Overview
- Trial Therapeutic Area
- Infectious Disease | Rare Disease
- Trial Disease
- Chronic hepatitis D (HDV) infection
- Trial Stage
- Phase II
- Drug Modality
- Oligonucleotide | Monoclonal antibody | Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 21-02-2025
- First CTIS Authorization Date
- 11-06-2025
Trial design
Randomised, open-label, hepcludex (bulevirtide) 2 mg powder for solution for injection — comparator arm; max daily dose amount 2 mg; route: subcutaneous injection; (commercial product hepcludex). investigational arms: tobevibart (vir-3434) + elebsiran (vir-2218) combination therapy (routes: subcutaneous use); specific dosing schedules for investigational products not specified in the provided metadata.-controlled Phase II trial across 33 sites in Germany, Bulgaria, Romania and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- HEPCLUDEX (bulevirtide) 2 mg powder for solution for injection — comparator arm; max daily dose amount 2 mg; route: subcutaneous injection; (commercial product HEPCLUDEX). Investigational arms: Tobevibart (VIR-3434) + Elebsiran (VIR-2218) combination therapy (routes: subcutaneous use); specific dosing schedules for investigational products not specified in the provided metadata.
- Target Sample Size
- 58
- Trial Duration For Participant
- 1680
Eligibility
Recruits 58 isVulnerablePopulationSelected = true. Only adults (≥18 to ≤70 years) are eligible. Dedicated pregnancy informed consent forms and 'Pregnant participant partner' ICF documents are included in the submission (country- and language-specific ICFs present), indicating additional consent materials for pregnant participants/partners. Consent is provided by the participant (no assent/minor consent procedures are listed)..
- Vulnerable Population
- isVulnerablePopulationSelected = true. Only adults (≥18 to ≤70 years) are eligible. Dedicated pregnancy informed consent forms and 'Pregnant participant partner' ICF documents are included in the submission (country- and language-specific ICFs present), indicating additional consent materials for pregnant participants/partners. Consent is provided by the participant (no assent/minor consent procedures are listed).
Inclusion criteria
- {"criterion_text":"- Adult men and women aged ≥ 18 years (or age of legal consent, whichever is older) to ≤ 70 years at the time of signing informed consent"}
- {"criterion_text":"- Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening."}
- {"criterion_text":"- Noncirrhotic or compensated cirrhotic liver disease at screening"}
- {"criterion_text":"- BMI ≥ 18 kg/m2 to ≤ 40 kg/m2"}
- {"criterion_text":"- On NRTI therapy against HBV for at least 12 weeks prior to Day 1 or have HBV DNA < 10 IU/ml at screening, and currently on locally approved NRTI therapy. Participants must be on one of the following NRTI therapies starting at Day 1: tenofovir alafenamide (taken alone or as part of fixed-dose combination therapy), tenofovir disoproxil fumarate (taken alone or as part of fixed-dose combination therapy), or entecavir."}
- {"criterion_text":"- Note: Other protocol defined Inclusion criteria may apply"}
Exclusion criteria
- {"criterion_text":"- Current or prior history of any of the following: a. Clinically significant laboratory abnormalities, co-morbid medical condition (other than HBV/HDV coinfection) or planned medical procedure that may interfere with the participant’s treatment, assessment, or compliance with the protocol. b. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. c. Current or previous (within 24 months of screening) clinically identified hepatic decompensation d. Bone marrow, peripheral blood stem-cell or solid organ transplantation e. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. f. Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; ductal carcinoma in situ and cervical carcinoma in situ is allowed if appropriately treated prior to screening); participants under evaluation for malignancy are not eligible. g. Significant drug allergy (such as anaphylaxis or hepatotoxicity)"}
- {"criterion_text":"- One or more additional known primary or secondary causes of liver disease, other than hepatitis B or hepatitis D (i.e., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, Wilson’s disease, other congenital or metabolic condition affecting the liver, congestive heart failure, etc)."}
- {"criterion_text":"- History of clinically significant immune complex disease as determined by the Investigator."}
- {"criterion_text":"- History of anaphylaxis, allergic reactions, hypersensitivity, or intolerance to study drug, study drug components (e.g., oligonucleotide and/or GalNAc), its metabolites or excipients"}
- {"criterion_text":"- Participants with active HCV (participants with HCV antibodies can be enrolled if screening HCV RNA PCR test is negative)."}
- {"criterion_text":"- Participants with uncontrolled HIV-1 infection (defined as confirmed HIV-1 RNA>200 copies/mL or CD4+ T cell counts < 500/mm3 within the last 12 months) or any HIV-2 infection."}
- {"criterion_text":"- Any previous treatment with bulevirtide (BLV)."}
- {"criterion_text":"- ALT ≥ 5 × ULN"}
- {"criterion_text":"- Note: Other protocol defined Exclusion criteria may apply"}
Endpoints
Primary endpoints
- {"endpoint_text":"- HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) at Week 48 (Part 1)","definition_or_measurement_approach":"Virologic measurement: HDV RNA measurement by PCR with threshold LLOQ; endpoint assessed at Week 48 (Part 1) as HDV RNA < LLOQ and Target Not Detected (TND)."}
- {"endpoint_text":"- Part 2: HDV RNA < LLOQ, TND 24 weeks after end of treatment interruption (Week 120)","definition_or_measurement_approach":"Virologic measurement: HDV RNA by PCR with threshold LLOQ; assessed 24 weeks after treatment interruption (Week 120) for sustained virologic response (SVR) defined as HDV RNA < LLOQ and TND."}
- {"endpoint_text":"- Primary safety – Incidence of TEAEs and SAEs through Week 48","definition_or_measurement_approach":"Safety measurement: incidence (frequency) of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) captured through Week 48."}
Secondary endpoints
- {"endpoint_text":"- • HDV RNA < LLOQ at Week 48 • Change from baseline in HDV RNA at Week 48","definition_or_measurement_approach":"HDV RNA measured by PCR at Week 48 (LLOQ); change from baseline computed at Week 48."}
- {"endpoint_text":"- Change from baseline in ALT at Week 48","definition_or_measurement_approach":"ALT (alanine aminotransferase) levels measured at baseline and Week 48; change from baseline reported."}
- {"endpoint_text":"- Change from baseline in liver stiffness as measured by liver elastography at Week 48","definition_or_measurement_approach":"Liver stiffness measured by elastography at baseline and Week 48; change from baseline reported."}
- {"endpoint_text":"- • Incidence of decompensated cirrhosis (clinical event or CPT score ≥ 7) by Week 48 • Incidence of HCC and progression to liver failure requiring transplantation or resulting in death by Week 48","definition_or_measurement_approach":"Clinical event capture of decompensated cirrhosis (clinical criteria or Child-Pugh-Turcotte (CPT) score ≥7), incidence of hepatocellular carcinoma (HCC), and progression to liver failure requiring transplant or resulting in death through Week 48."}
- {"endpoint_text":"- • Change from baseline in HBsAg at Week 48 • Categorical summary of HBsAg at Week 48","definition_or_measurement_approach":"Serologic measurement of HBsAg at baseline and Week 48; continuous change and categorical summary reported."}
- {"endpoint_text":"- • HDV RNA < LLOQ, TND at Week 96, Week 120, Week 144, Week 192 and Week 240 • HDV RNA < LLOQ at Week 96, Week 120, Week 144, Week 192 and Week 240 • Change from baseline in HDV RNA at Week 96, Week 120, Week 144, Week 192 and Week 240 • Change from baseline in HDV RNA from tobevibart+elebsiran interruption at Week 96 to Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"Long-term virologic assessments by HDV RNA PCR at Weeks 96, 120, 144, 192, and 240; includes presence < LLOQ and TND and change from baseline; includes analyses around interruption of tobevibart+elebsiran."}
- {"endpoint_text":"- •Change from baseline in ALT at Week 96, Week 120, Week 144, Week 192 and Week 240 • Change from baseline in ALT from tobevibart+elebsiran interruption at Week 96 to Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"ALT measured at later follow-up timepoints (Weeks 96–240); change from baseline reported and analyzed relative to treatment interruption."}
- {"endpoint_text":"- • Change from baseline in liver stiffness as measured by liver elastography at Week 96, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"Liver elastography measurements at specified long-term timepoints; change from baseline reported."}
- {"endpoint_text":"- • Incidence of decompensated cirrhosis (clinical event or CPT score ≥ 7) by Week 96, Week 120, Week 144, Week 192 and Week 240 • Incidence of HCC and progression to liver failure requiring transplantation or resulting in death by Week 96, Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"Clinical event capture of decompensated cirrhosis, HCC incidence, and progression to liver failure through longer-term timepoints (Weeks 96–240)."}
- {"endpoint_text":"- • Categorical summary of HBsAg at Week 96, Week 120, Week 144, Week 192 and Week 240 • Change from baseline in HBsAg at Week 96, Week 120, Week 144, Week 192 and Week 240","definition_or_measurement_approach":"HBsAg serology categorized and change-from-baseline assessed at long-term timepoints (Weeks 96–240)."}
- {"endpoint_text":"- • Incidence of TEAEs and SAEs through Week 96, Week 120, Week 144, Week 192 and Week 240 (secondary safety)","definition_or_measurement_approach":"Safety: incidence of TEAEs and SAEs recorded through long-term follow-up timepoints."}
- {"endpoint_text":"- • Incidence of AEs, SAEs and lab abnormalities from time of tobevibart+elebsiran interruption (Week 96) through Week 120, Week 144, Week 192 and Week 240 (secondary safety)","definition_or_measurement_approach":"Safety: incidence of adverse events, serious adverse events and laboratory abnormalities from treatment interruption onward through follow-up timepoints."}
Recruitment
- Digital Remote Recruitment
- True, recruitment materials include digital patient brochures, online advertisements, social media clinical trial posts, online banners, and a digital participant study guide (country- and language-specific versions available).
- Planned Sample Size
- 58
- Recruitment Window Months
- 77
- Consent Approach
- Informed consent is provided by the participant (adults only; age of legal consent applies). Multiple subject information sheets and informed consent forms (ICFs) are included for different countries and languages (English, French, Dutch, Italian, Bulgarian, Romanian, Spanish, etc.). Specific pregnancy ICFs and 'Pregnant participant partner' ICFs are included indicating additional consent materials for pregnant participants/partners. No assent procedures for minors are listed (trial enrols adults ≥18).
Methods
- Digital Patient Brochure (country- and language-specific digital brochures listed, e.g., 'Digital Patient Brochure' - used online for patient information)
- Online advertisements / Social Media clinical trial posts (documents titled 'Online Advertisements_Social Media_Clinical Trial Posts' / 'Social Media' for recruitment)
- Banner advertisements for sites (documents titled 'Banner advertisements for sites')
- Physician referral letters / Doctor-to-Doctor Patient Referral (documents titled 'Physician Referral Letter' / 'Doctor to Doctor Patient Referral')
- Patient brochures and Hepatitis D brochures (site-facing and patient-facing printed materials)
- Study information slides and digital participant study guides (documents titled 'Study Information Slides' and 'Digital Participant Study Guide')
Geography
- Total Number Of Sites
- 33
- Total Number Of Participants
- 42
Germany
- Earliest CTIS Part Ii Submission Date
- 27-05-2025
- Latest Decision Or Authorization Date
- 07-01-2026
- Processing Time Days
- 225
- Number Of Sites
- 4
- Number Of Participants
- 3
Sites
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Gastroenterologie, Hepatologie und 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
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik m. S. Hepatologie und Gastroenterologie
- Principal Investigator Name
- Münevver Demir
- Principal Investigator Email
- muenevver.demir@charite.de
- Contact Person Name
- Münevver Demir
- Contact Person Email
- muenevver.demir@charite.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Gastroenterologie, Hepatologie und Transplantationsmedizin
- Principal Investigator Name
- Susanne Beckebaum
- Principal Investigator Email
- susanne.beckebaum@uk-essen.de
- Contact Person Name
- Susanne Beckebaum
- Contact Person Email
- susanne.beckebaum@uk-essen.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Medizinische Klinik 1
- Principal Investigator Name
- Kathin Sprinzl
- Principal Investigator Email
- Sprinzl@med.uni-frankfurt.de
- Contact Person Name
- Kathin Sprinzl
- Contact Person Email
- Sprinzl@med.uni-frankfurt.de
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 02-06-2025
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 176
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Clinic of Gastroenterology
- Principal Investigator Name
- Krasimir Antonov
- Principal Investigator Email
- krasi_antonov@abv.bg
- Contact Person Name
- Krasimir Antonov
- Contact Person Email
- krasi_antonov@abv.bg
- Site Name
- Umbal - Prof. D-R Stoyan Kirkovich AD
- Department Name
- Department of Gastroenterology
- Principal Investigator Name
- Mariana Radicheva
- Principal Investigator Email
- dr.mradicheva@gmail.com
- Contact Person Name
- Mariana Radicheva
- Contact Person Email
- dr.mradicheva@gmail.com
- Site Name
- Acibadem City Clinic Tokuda University Hospital EAD
- Department Name
- Department of Gastroenterology
- Principal Investigator Name
- Rozalina Balabanska
- Principal Investigator Email
- rozabalabanska@abv.bg
- Contact Person Name
- Rozalina Balabanska
- Contact Person Email
- rozabalabanska@abv.bg
Romania
- Earliest CTIS Part Ii Submission Date
- 02-06-2025
- Latest Decision Or Authorization Date
- 15-12-2025
- Processing Time Days
- 196
- Number Of Sites
- 3
- Number Of Participants
- 15
Sites
- Site Name
- Institutul Clinic Fundeni
- Department Name
- Sectia Medicina Interna II
- Principal Investigator Name
- Elena Laura Iliescu
- Principal Investigator Email
- laura_ate@yahoo.com
- Contact Person Name
- Elena Laura Iliescu
- Contact Person Email
- laura_ate@yahoo.com
- Site Name
- Institutul National De Boli Infectioase Prof.Dr.Matei Bals
- Department Name
- Sectia Clinica II-Boli Infectioase Adulti
- Principal Investigator Name
- Anca Streinu-Cercel
- Principal Investigator Email
- anca_sc@yahoo.com
- Contact Person Name
- Anca Streinu-Cercel
- Contact Person Email
- anca_sc@yahoo.com
- Site Name
- Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
- Department Name
- Sectia Clinica VI-Adulti
- Principal Investigator Name
- Simin Aysel Florescu
- Principal Investigator Email
- siminflorescu@yahoo.com
- Contact Person Name
- Simin Aysel Florescu
- Contact Person Email
- siminflorescu@yahoo.com
Italy
- Earliest CTIS Part Ii Submission Date
- 12-03-2025
- Latest Decision Or Authorization Date
- 27-11-2025
- Processing Time Days
- 260
- Number Of Sites
- 4
- Number Of Participants
- 2
Sites
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Hepatology Unit
- Principal Investigator Name
- Maurizia Rossana Brunetto
- Principal Investigator Email
- Maurizia.brunetto@unipi.it
- Contact Person Name
- Maurizia Rossana Brunetto
- Contact Person Email
- Maurizia.brunetto@unipi.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Gastroentherology
- 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
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Gastroenterology and Hepatology
- 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
- Humanitas Mirasole S.p.A.
- Department Name
- U.O Gastroenterology, Internal Medicine and Hepatology
- Principal Investigator Name
- Alessio Aghemo
- Principal Investigator Email
- alessio.aghemo@humanitasresearch.it
- Contact Person Name
- Alessio Aghemo
- Contact Person Email
- alessio.aghemo@humanitasresearch.it
Belgium
- Earliest CTIS Part Ii Submission Date
- 30-05-2025
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 206
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- Hopital Erasme
- Department Name
- gastroenterology
- Principal Investigator Name
- Christophe Moreno
- Principal Investigator Email
- christophe.moreno@erasme.ulb.ac.be
- Contact Person Name
- Christophe Moreno
- Contact Person Email
- christophe.moreno@erasme.ulb.ac.be
- Site Name
- SGS Belgium
- Department Name
- gastroenterology
- Principal Investigator Name
- Stefan Bourgeois
- Principal Investigator Email
- stefan.bourgeois@zas.be
- Contact Person Name
- Stefan Bourgeois
- Contact Person Email
- stefan.bourgeois@zas.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- gastroenterology
- Principal Investigator Name
- Thomas Vanwolleghem
- Principal Investigator Email
- thomas.vanwolleghem@uza.be
- Contact Person Name
- Thomas Vanwolleghem
- Contact Person Email
- thomas.vanwolleghem@uza.be
- Site Name
- Chu Brugmann
- Department Name
- gastroenterology
- Principal Investigator Name
- Luc Lasser
- Principal Investigator Email
- luc.lasser@chu-brugmann.be
- Contact Person Name
- Luc Lasser
- Contact Person Email
- luc.lasser@chu-brugmann.be
Spain
- Earliest CTIS Part Ii Submission Date
- 22-05-2025
- Latest Decision Or Authorization Date
- 28-11-2025
- Processing Time Days
- 190
- Number Of Sites
- 5
- Number Of Participants
- 4
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hepatology
- Principal Investigator Name
- Sabela Lens García
- Principal Investigator Email
- slens@clinic.cat
- Contact Person Name
- Sabela Lens García
- Contact Person Email
- slens@clinic.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hepatology
- Principal Investigator Name
- María Buti Ferret
- Principal Investigator Email
- mariabutiferret@gmail.com
- Contact Person Name
- María Buti Ferret
- Contact Person Email
- mariabutiferret@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Digestive Service
- Principal Investigator Name
- Joaquín Cabezas González
- Principal Investigator Email
- joaquin.cabezas@scsalud.es
- Contact Person Name
- Joaquín Cabezas González
- Contact Person Email
- joaquin.cabezas@scsalud.es
- Site Name
- Hospital General Universitario De Valencia
- Department Name
- Digestive Service
- Principal Investigator Name
- Juan José Urquijo Ponce
- Principal Investigator Email
- juanjo.urquijo@gmail.com
- Contact Person Name
- Juan José Urquijo Ponce
- Contact Person Email
- juanjo.urquijo@gmail.com
- Site Name
- Hospital Universitario La Paz
- Department Name
- Digestive Service
- Principal Investigator Name
- Antonio Olveira Martín
- Principal Investigator Email
- aolveiram@gmail.com
- Contact Person Name
- Antonio Olveira Martín
- Contact Person Email
- aolveiram@gmail.com
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-05-2025
- Latest Decision Or Authorization Date
- 25-11-2025
- Processing Time Days
- 181
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Eric Tjwa
- Principal Investigator Email
- eric.tjwa@radboudumc.nl
- Contact Person Name
- Eric Tjwa
- Contact Person Email
- eric.tjwa@radboudumc.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Milan Johan Sonneveld
- Principal Investigator Email
- m.j.sonneveld@erasmusmc.nl
- Contact Person Name
- Milan Johan Sonneveld
- Contact Person Email
- m.j.sonneveld@erasmusmc.nl
- Site Name
- Amsterdam UMC Research B.V.
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Bart Takkenberg
- Principal Investigator Email
- r.b.takkenberg@amsterdamumc.nl
- Contact Person Name
- Bart Takkenberg
- Contact Person Email
- r.b.takkenberg@amsterdamumc.nl
France
- Earliest CTIS Part Ii Submission Date
- 27-05-2025
- Latest Decision Or Authorization Date
- 12-02-2026
- Processing Time Days
- 261
- Number Of Sites
- 7
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier De Versailles
- Department Name
- Hepato-gastroentorology
- Principal Investigator Name
- Christiane Stern
- Principal Investigator Email
- cstern@ght78sud.fr
- Contact Person Name
- Christiane Stern
- Contact Person Email
- cstern@ght78sud.fr
- Site Name
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Hepatology
- 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
- 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
- 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
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Hepato-gastroentorology
- Principal Investigator Name
- Paul CARRIER
- Principal Investigator Email
- paul.carrier@chu-limoges.fr
- Contact Person Name
- Paul CARRIER
- Contact Person Email
- paul.carrier@chu-limoges.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hepatology
- Principal Investigator Name
- Sophie METIVIER
- Principal Investigator Email
- metivier.s@chu-toulouse.fr
- Contact Person Name
- Sophie METIVIER
- Contact Person Email
- metivier.s@chu-toulouse.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Hepato-gastroentorology
- 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
Sponsor
Primary sponsor
- Full Name
- Vir Biotechnology Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- sponsorDuties code: 6
- Name
- IQVIA Limited
- Responsibilities
- sponsorDuties codes: 1, 12, 15 (Study scales (questionnaires) & eCOA tablet), 2, 5
- Name
- Syneos Health Inc.
- Responsibilities
- sponsorDuties code: 15 (CTA, budget ancillary documents); sample receipt activities also listed for Syneos with sponsorDuties code 4
- Name
- SGS Belgium
- Responsibilities
- listed as third party for Belgium recruitment activities (organisation present in trialSites listing)
- Name
- QPS LLC
- Responsibilities
- sponsorDuties code: 4
- Name
- Q Squared Solutions Limited
- Responsibilities
- sponsorDuties code: 4
- Name
- Frontage Laboratories Inc.
- Responsibilities
- sponsorDuties code: 4
Third parties
- {"country":"Denmark","full_name":"Sply ApS","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"IMP Distribution, QP Release (sponsorDuties code 15)","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties code: 6","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1, 12, 15 (Study scales (questionnaires) & eCOA tablet), 2, 5","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties code: 15 (CTA, budget ancillary documents)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"QPS LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc. (sample receipt address)","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties code: 7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Edetek Inc.","duties_or_roles":"sponsorDuties code: 10","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Ubc Late Stage (UK) Limited","duties_or_roles":"sponsorDuties code: 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- VIR-2218
- Active Substance
- ELEBSIRAN
- Modality
- Oligonucleotide
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS USE
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Maximum Dose
- 00 mg (maxDailyDoseAmount / maxTotalDoseAmount fields indicate 00)
- Investigational Product Name
- VIR-3434
- Active Substance
- TOBEVIBART
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS USE
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Maximum Dose
- 00 mg (maxDailyDoseAmount / maxTotalDoseAmount fields indicate 00)
- Investigational Product Name
- HEPCLUDEX 2 mg powder for solution for injection
- Active Substance
- BULEVIRTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- prodAuthStatus: 2 (marketingAuthNumber: EU/1/20/1446/001)
- Orphan Designation
- Yes
- Frequency
- maxDailyDoseAmount indicated as 2 mg
- Maximum Dose
- maxTotalDoseAmount: 672 mg
- Combination Treatment
- Yes
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