Clinical trial • Phase III • Infectious Disease|Rare Disease
BJT-778 for Chronic Hepatitis D Infection
Phase III trial of BJT-778 for Chronic Hepatitis D Infection.
Overview
- Trial Therapeutic Area
- Infectious Disease|Rare Disease
- Trial Disease
- Chronic Hepatitis D Infection
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 08-03-2025
- First CTIS Authorization Date
- 18-07-2025
Trial design
Randomised, open-label, bjt-778 (bjt-778) subcutaneous injection — prod info lists max daily dose 300 mg; bulevirtide (bulevirtide) subcutaneous injection — prod info lists max daily dose 2 mg; specific dosing schedule in the protocol is not specified in the ctis record.-controlled Phase III trial in Sweden, Austria, Czechia and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- BJT-778 (BJT-778) subcutaneous injection — prod info lists max daily dose 300 mg; Bulevirtide (BULEVIRTIDE) subcutaneous injection — prod info lists max daily dose 2 mg; specific dosing schedule in the protocol is not specified in the CTIS record.
- Target Sample Size
- 172
- Trial Duration For Participant
- 672
Eligibility
Recruits 172 No vulnerable populations selected. Participants must be ≥18 and 'Willing and able to provide written informed consent.' No assent procedures described..
- Pregnancy Exclusion
- Pregnant or nursing females
- Vulnerable Population
- No vulnerable populations selected. Participants must be ≥18 and 'Willing and able to provide written informed consent.' No assent procedures described.
Inclusion criteria
- {"criterion_text":"- Willing and able to provide written informed consent\n- Male or female, ≥18 years of age at Screening\n- Confirmation of chronic HDV infection, defined as a positive for anti-HDV antibody test or HDV RNA at least 6 months prior to Day 1. If prior documentation is not available, then HDV RNA positivity along with evidence of fibrosis (liver stiffness of ≥7 kPa) is acceptable.\n- HDV RNA >500 IU/mL at Screening\n- ALT >ULN at Screening\n- Taking or willing to take tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or entecavir (ETV) at baseline, and willing to remain on stable treatment for the duration of the study."}
Exclusion criteria
- {"criterion_text":"- Pregnant or nursing females\n- Male or female participants of childbearing potential unwilling to comply with contraception requirements during the study\n- Current, prior history, or is under evaluation for any of the following: a)\tDifficulty with blood collection and/or poor venous access for the purposes of phlebotomy b)\tClinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). Incidental small ascites on imaging without other clinical symptoms/signs would not exclude the participants. c)\tHepatocellular carcinoma; suspected HCC on ultrasound at Screening d)\tVasculitis e)\tExtrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa) f)\tSolid organ or bone marrow transplantation g)\tSignificant pulmonary disease (e.g., O2-dependent or FEV1 ≤50% predicted value) h)\tSignificant cardiac disease (e.g., history of myocardial infarctions within 6 months, any history of ventricular tachycardia, congestive heart failure, dilated cardiomyopathy with left ventricular ejection fraction <40%) i)\tMalignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to Screening).\n- CTP >6 (Class B or C) (see Section 6.7.7.2)\n- Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or hepatitis A virus) or non-viral hepatitis that has the potential to impact interpretation of data. Exceptions to this criterion include fatty liver without any signs of steatohepatitis or past HCV infection that has resolved or been successfully treated (HCV RNA negative ≥6 months) prior to Screening.\n- Uncontrolled HIV infection defined as having quantifiable HIV RNA levels in the blood at Screening\n- History of hypersensitivity to any of the components in the brelovitug or bulevirtide formulation\n- Screening laboratory results as follows, or any other clinically significant abnormalities in Screening laboratory values that would render a participant unsuitable for inclusion: a)\tPlatelet count <50,000/mm3 b)\tHemoglobin <10.0 g/dL c)\tCreatinine clearance by Cockcroft-Gault (CLCr) <50 mL/min d)\tAlpha fetoprotein >100 ng/mL\n- Treatment with an investigational drug, a biological agent, or device within 4 weeks of baseline or 5 half-lives, whichever is longer\n- Received bulevirtide at any time prior to Screening, or unwilling or unable to receive bulevirtide treatment.\n- Unwilling or unable to self-inject study medication, including daily injection with bulevirtide\n- Use of any prohibited concomitant medications, including any interferon within 12 weeks prior to Screening, as described in Section 7.8, or described in the Hepcludex SmPC/Product Information\n- Regular alcohol misuse, defined as weekly intake of ≥14 drinks per week (average of ≥2 drinks per day) within 12 months of Screening\n- Clinically relevant drug abuse (excluding cannabis) within 12 months of Screening\n- Unwillingness to comply with study procedures as specified by this protocol, or unwillingness to cooperate fully with the Investigator\n- Have any other conditions (medical, social, psychiatric, or other), which in the opinion of the Investigator would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The proportion of participants who achieve a composite endpoint defined as undetectable HDV RNA and ALT normalization. •\tUndetectable HDV RNA is defined as HDV RNA < the lower limit of quantification [LLOQ], target not detected (TND) •\tALT normalization is defined as a decrease in ALT from baseline to ≤ULN","definition_or_measurement_approach":"Undetectable HDV RNA is defined as HDV RNA < the lower limit of quantification (LLOQ), target not detected (TND). ALT normalization is defined as a decrease in ALT from baseline to ≤ULN."}
Secondary endpoints
- {"endpoint_text":"- 1. Safety endpoint will evaluate: •\tIncidence and severity of treatment-emergent adverse events (TEAE) •\tProportion of participants who permanently discontinue treatment due to an adverse event Comparison with bulevirtide will include data through 48 weeks","definition_or_measurement_approach":"Incidence and severity of TEAEs; proportion permanently discontinuing treatment due to an AE; comparisons with bulevirtide include data through 48 weeks."}
- {"endpoint_text":"- 2. The proportion of participants who achieve the following during treatment at Weeks 24, 48, and 96: •HDV RNA ≥2 log10 IU/mL decline from baseline or undetectable •HDV RNA ","definition_or_measurement_approach":"Proportion achieving ≥2 log10 IU/mL decline from baseline in HDV RNA or undetectable HDV RNA at Weeks 24, 48 and 96 (as stated)."}
- {"endpoint_text":"- 3. •\tChange from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan) at Weeks 24, 48, and 96 •\tChange from baseline in APRI (AST-to-platelet ratio index) at Weeks 24, 48, and 96","definition_or_measurement_approach":"Change from baseline in liver stiffness measured by transient elastography (e.g., FibroScan); change from baseline in APRI at Weeks 24, 48, 96."}
- {"endpoint_text":"- •\tChange from baseline in CTP score at Weeks 24, 48, and 96 in cirrhotic participants •\tChange from baseline in Model for End-Stage Liver Disease (MELD) score at Weeks 24, 48, and 96 in cirrhotic participants","definition_or_measurement_approach":"Change from baseline in CTP and MELD scores in cirrhotic participants at Weeks 24, 48, and 96."}
- {"endpoint_text":"- •\tProportion of participants with clinical disease progression from baseline in HDV-associated liver disease at Weeks 24, 48, and 96. Progression will be determined by the Independent Data Monitoring Committee (IDMC). Comparison with bulevirtide will include data through 48 weeks.","definition_or_measurement_approach":"Proportion with clinical disease progression as determined by the IDMC at Weeks 24, 48, and 96; comparison with bulevirtide includes data through 48 weeks."}
- {"endpoint_text":"- 4. Proportion of participants at Weeks 72 and 96 compared to those at Week 48 that achieve or maintain (defined as no change or improvement in) the below: • HDV RNA ≥2 log10 IU/mL decline from baseline or undetectable • HDV RNA ","definition_or_measurement_approach":"Proportion achieving or maintaining (no change or improvement) virologic responses (≥2 log10 decline or undetectable HDV RNA) at Weeks 72 and 96 vs Week 48."}
- {"endpoint_text":"- 5. Safety endpoints, defined above, will be compared between the first 48 weeks (Weeks 0-48) and the second 48 weeks (Week 48-96), including change in serum total bile acids.","definition_or_measurement_approach":"Safety endpoints comparison between Weeks 0-48 and Weeks 48-96; includes change in serum total bile acids."}
- {"endpoint_text":"- 7. •\tChange from baseline in Chronic Liver Disease Questionnaire-HBV (CLDQ-HBV) and Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F) at Weeks 24, 48, and 96 •\tCompare change from baseline in CLDQ-HBV and FACIT-F between brelovitug and bulevirtide at Weeks 24 and 48, and at Week 48 (switch) and Week 96 (Arm 2)","definition_or_measurement_approach":"Change from baseline in CLDQ-HBV and FACIT-F at Weeks 24, 48, 96; between-arm comparisons at Weeks 24 and 48 and for switch/sustained assessments."}
- {"endpoint_text":"- 6. Proportion of participants who achieve HDV RNA ","definition_or_measurement_approach":"Incomplete text in source; endpoint relates to proportion achieving HDV RNA < LLOQ / target not detected during follow-up as referenced elsewhere (post-treatment follow-up at weeks 24 and 48)."}
Recruitment
- Planned Sample Size
- 172
- Recruitment Window Months
- 37
- Consent Approach
- Written informed consent provided by the participant (participants must be ≥18 and 'Willing and able to provide written informed consent'). Country-specific subject information and informed consent forms (L1 SIS and ICF Main Adult) are available in multiple country/language versions (examples in the dossier: German (AT/DE), French (FR), Italian (IT), Spanish (ES), Czech (CZ), Romanian (RO), English). Pregnant-partner information and optional future research ICFs are also provided in country-specific versions.
Geography
- Total Number Of Sites
- 48
- Total Number Of Participants
- 141
Sweden
- Earliest CTIS Part Ii Submission Date
- 14-05-2025
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 243
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Karolinska University Hospital
- Department Name
- Department of Infectious Diseases
- Principal Investigator Name
- Soo Aleman
- Principal Investigator Email
- soo.aleman@regionstockholm.se
- Contact Person Name
- Soo Aleman
- Contact Person Email
- soo.aleman@regionstockholm.se
Austria
- Earliest CTIS Part Ii Submission Date
- 27-05-2025
- Latest Decision Or Authorization Date
- 13-01-2026
- Processing Time Days
- 231
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Universitätsklinikum St. Pölten
- Department Name
- Klinische Abteilung für Innere Medizin 2
- Principal Investigator Name
- Andreas Maieron
- Principal Investigator Email
- andreas.maieron@stpoelten.lknoe.at
- Contact Person Name
- Andreas Maieron
- Contact Person Email
- andreas.maieron@stpoelten.lknoe.at
- Site Name
- Medical University of Graz
- Department Name
- Internal Medicine
- Principal Investigator Name
- Vanessa Stadlbauer-Köllner
- Principal Investigator Email
- vanessa.stadlbauer@medunigraz.de
- Contact Person Name
- Vanessa Stadlbauer-Köllner
- Contact Person Email
- vanessa.stadlbauer@medunigraz.de
- Site Name
- Medical University Innsbruck
- Department Name
- Internal Medicine 1
- Principal Investigator Name
- Heinz Zoller
- Principal Investigator Email
- heinz.zoller@i-med.ac.at
- Contact Person Name
- Heinz Zoller
- Contact Person Email
- heinz.zoller@i-med.ac.at
Czechia
- Earliest CTIS Part Ii Submission Date
- 16-05-2025
- Latest Decision Or Authorization Date
- 13-01-2026
- Processing Time Days
- 242
- Number Of Sites
- 5
- Number Of Participants
- 17
Sites
- Site Name
- Institute For Clinical And Experimental Medicine
- Department Name
- Klinika hepatogastroenterologie
- Principal Investigator Name
- Jan Šperl
- Principal Investigator Email
- jan.sperl@ikem.cz
- Contact Person Name
- Jan Šperl
- Contact Person Email
- jan.sperl@ikem.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Klinika infekčních chorob
- Principal Investigator Name
- Petr Husa
- Principal Investigator Email
- husa.petr@fnbrno.cz
- Contact Person Name
- Petr Husa
- Contact Person Email
- husa.petr@fnbrno.cz
- Site Name
- Klin Med s.r.o.
- Department Name
- Gastroenterologie
- Principal Investigator Name
- Petr Urbánek
- Principal Investigator Email
- klinmed@klinmed.cz
- Contact Person Name
- Petr Urbánek
- Contact Person Email
- klinmed@klinmed.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Klinika infekčních nemocí
- Principal Investigator Name
- Jaroslav Kapla
- Principal Investigator Email
- jaroslav.kapla@fnhk.cz
- Contact Person Name
- Jaroslav Kapla
- Contact Person Email
- jaroslav.kapla@fnhk.cz
- Site Name
- Krajska nemocnice Liberec a.s.
- Department Name
- Oddělení infekčních nemocí
- Principal Investigator Name
- Adam Vitouš
- Principal Investigator Email
- adam.vitous@nemlib.cz
- Contact Person Name
- Adam Vitouš
- Contact Person Email
- adam.vitous@nemlib.cz
Italy
- Earliest CTIS Part Ii Submission Date
- 19-05-2025
- Latest Decision Or Authorization Date
- 09-01-2026
- Processing Time Days
- 235
- Number Of Sites
- 8
- Number Of Participants
- 22
Sites
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- Hepatology
- 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
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- SC Gastroenterologia ed Epatologia
- 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
- National Institute For Infectious Diseases Lazzaro Spallanzani
- Department Name
- Infectious Diseases - Hepatology
- Principal Investigator Name
- Gianpiero D'Offizi
- Principal Investigator Email
- gianpiero.doffizi@inmi.it
- Contact Person Name
- Gianpiero D'Offizi
- Contact Person Email
- gianpiero.doffizi@inmi.it
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Infectious Disease
- Principal Investigator Name
- Massimo Puoti
- Principal Investigator Email
- massimo.puoti@ospedaleniguarda.it
- Contact Person Name
- Massimo Puoti
- Contact Person Email
- massimo.puoti@ospedaleniguarda.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Gastroenterology and Hepatology
- 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
- University Of Parma
- Department Name
- Medicine and Surgery
- Principal Investigator Name
- Gabriele Missale
- Principal Investigator Email
- gabriele.missale@unipr.it
- Contact Person Name
- Gabriele Missale
- Contact Person Email
- gabriele.missale@unipr.it
- Site Name
- IRCCS Humanitas Research Hospital
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Alessio Aghemo
- Principal Investigator Email
- alessio.aghemo@hunimed.eu
- Contact Person Name
- Alessio Aghemo
- Contact Person Email
- alessio.aghemo@hunimed.eu
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda (additional listed site entry)
- Department Name
- Gastroenterology and Hepatology
Spain
- Earliest CTIS Part Ii Submission Date
- 09-05-2025
- Latest Decision Or Authorization Date
- 13-01-2026
- Processing Time Days
- 249
- Number Of Sites
- 8
- Number Of Participants
- 35
Sites
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Raúl Andrade Bellido
- Principal Investigator Email
- andrade@uma.es
- Contact Person Name
- Raúl Andrade Bellido
- Contact Person Email
- andrade@uma.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Infectious Disease Department
- Principal Investigator Name
- Luis Enrique Morano Amado
- Principal Investigator Email
- luis.morano.amado@gmail.com
- Contact Person Name
- Luis Enrique Morano Amado
- Contact Person Email
- luis.morano.amado@gmail.com
- Site Name
- Hospital Universitario Torrecardenas
- Department Name
- Internal medicine
- Principal Investigator Name
- Matías Estévez Escobar
- Principal Investigator Email
- matiasestevez@gmail.com
- Contact Person Name
- Matías Estévez Escobar
- Contact Person Email
- matiasestevez@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Agustin Albillos Martinez
- Principal Investigator Email
- agustin.albillos@uah.es
- Contact Person Name
- Agustin Albillos Martinez
- Contact Person Email
- agustin.albillos@uah.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hepatology
- Principal Investigator Name
- Sabela Lens
- Principal Investigator Email
- slens@clinic.cat
- Contact Person Name
- Sabela Lens
- Contact Person Email
- slens@clinic.cat
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Gastroenterology
- Principal Investigator Name
- Susana Llerena Santiago
- Principal Investigator Email
- sllerena@humv.es
- Contact Person Name
- Susana Llerena Santiago
- Contact Person Email
- sllerena@humv.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Internal medicine
- Principal Investigator Name
- María Buti Ferret
- Principal Investigator Email
- mariaasuncion.buti@vallhebron.cat
- Contact Person Name
- María Buti Ferret
- Contact Person Email
- mariaasuncion.buti@vallhebron.cat
- Site Name
- Hospital Universitario Virgen De La Victoria (additional listed site entry)
Romania
- Earliest CTIS Part Ii Submission Date
- 15-04-2025
- Latest Decision Or Authorization Date
- 16-01-2026
- Processing Time Days
- 276
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes
- Department Name
- Boli Infectioase si Tropicale
- Principal Investigator Name
- Corneliu Petru Popescu
- Principal Investigator Email
- cornel160@yahoo.com
- Contact Person Name
- Corneliu Petru Popescu
- Contact Person Email
- cornel160@yahoo.com
- Site Name
- Institutul National De Boli Infectioase Prof.Dr.Matei Bals
- Department Name
- Boli Infectioase II
- Principal Investigator Name
- Liliana Lucia Preotescu
- Principal Investigator Email
- preolil17@yahoo.com
- Contact Person Name
- Liliana Lucia Preotescu
- Contact Person Email
- preolil17@yahoo.com
- Site Name
- Institutul National De Boli Infectioase Prof.Dr.Matei Bals (additional listed entry)
- Department Name
- Boli Infectioase
- Principal Investigator Name
- Oana Sandulescu
- Principal Investigator Email
- oana.sandulescu1@gmail.com
- Contact Person Name
- Oana Sandulescu
- Contact Person Email
- oana.sandulescu1@gmail.com
- Site Name
- Centrul Medical Unirea S.R.L.
- Department Name
- Boli Infectioase
- Principal Investigator Name
- Catalina Mihaela Luca
- Principal Investigator Email
- catalina_luca2006@yahoo.com
- Contact Person Name
- Catalina Mihaela Luca
- Contact Person Email
- catalina_luca2006@yahoo.com
- Site Name
- Spitalul Clinic De Boli Infectioase Constanta
- Department Name
- Boli Infectioase II
- Principal Investigator Name
- Irina Magdalena Dumitru
- Principal Investigator Email
- contact@infectioaseconstanta.ro
- Contact Person Name
- Irina Magdalena Dumitru
- Contact Person Email
- contact@infectioaseconstanta.ro
Germany
- Earliest CTIS Part Ii Submission Date
- 15-05-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 270
- Number Of Sites
- 5
- Number Of Participants
- 14
Sites
- Site Name
- Charité Universitätsmedizin Berlin, Campus Virchow-Klinikum
- Department Name
- Hepatologie, Gastroenterologie CVK
- Principal Investigator Name
- Muenevver Demir
- Principal Investigator Email
- muenevver.demir@charite.de
- Contact Person Name
- Muenevver Demir
- Contact Person Email
- muenevver.demir@charite.de
- Site Name
- Universitätsklinikum Düsseldorf
- Department Name
- Gastroenterologie, Hepatologie & 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
- Site Name
- Goethe University Frankfurt
- Department Name
- Innere Medizin, Gastroenterologie
- Principal Investigator Name
- Kathrin Andrea Sprinzl
- Principal Investigator Email
- sprinzl@med.uni-frankfurt.de
- Contact Person Name
- Kathrin Andrea Sprinzl
- Contact Person Email
- sprinzl@med.uni-frankfurt.de
- Site Name
- Rostock University Medical Center
- Department Name
- Gastroenterologie, Hepatologie, Infektiologie
- Principal Investigator Name
- Micha Löbermann
- Principal Investigator Email
- micha.loebermann@uni-rostock.de
- Contact Person Name
- Micha Löbermann
- Contact Person Email
- micha.loebermann@uni-rostock.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Gastroenterologie, Hepatologie and Endocrinologie
- 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
France
- Earliest CTIS Part Ii Submission Date
- 11-04-2025
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 390
- Number Of Sites
- 13
- Number Of Participants
- 25
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hôpital La Pitié-Salpétrière_Service Hépato-gastroentérologie
- Principal Investigator Name
- Dominique THABUT
- Principal Investigator Email
- Dominique.thabut@psl.aphp.fr
- Contact Person Name
- Dominique THABUT
- Contact Person Email
- Dominique.thabut@psl.aphp.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Hépato-gastro-entérologie
- 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
- Hospices Civils De Lyon
- Department Name
- Hépatologie et gastroentérologie
- 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 De Versailles
- Department Name
- Hôpital André Mignot_Service d’Hépato-gastro-entérologie
- 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 Bordeaux
- Department Name
- Hôpital Haut- Lévêque_Service d’Hépato-gastro-entérologie
- 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 Grenoble Alpes
- Department Name
- Hépato-gastroentérologie et oncologie digestive
- Principal Investigator Name
- Marie-Noëlle HILLERET
- Principal Investigator Email
- MNHilleret@chu-grenoble.fr
- Contact Person Name
- Marie-Noëlle HILLERET
- Contact Person Email
- MNHilleret@chu-grenoble.fr
- Site Name
- Assistance Publique Hopitaux De Paris (Creteil)
- Department Name
- Hépatologie
- Principal Investigator Name
- Patrick INGILIZ
- Principal Investigator Email
- Patrick.Ingiliz@aphp.fr
- Contact Person Name
- Patrick INGILIZ
- Contact Person Email
- Patrick.Ingiliz@aphp.fr
- Site Name
- Hopital Beaujon
- Department Name
- Hôpital Beaujon - Service d’Hépatalogie – Pavillon Abrami
- 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 Universitaire De Rennes
- Department Name
- Maladies du foie
- 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
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hépatologie
- 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 Et Universitaire De Limoges
- Department Name
- Hépato-gastro- entérologie
- 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 Lille
- Department Name
- Hôpital Claude Huriez_Maladies de l’appareil digestif
- Principal Investigator Name
- Alexandre LOUVET
- Principal Investigator Email
- Alexandre.louvet@chu-lille.fr
- Contact Person Name
- Alexandre LOUVET
- Contact Person Email
- Alexandre.louvet@chu-lille.fr
- Site Name
- Assistance Publique Hopitaux De Paris (additional site)
- Department Name
- Hépatologie
- Principal Investigator Name
- Vincent MALLET
- Principal Investigator Email
- vincent.mallet@aphp.fr
- Contact Person Name
- Vincent MALLET
- Contact Person Email
- vincent.mallet@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Bluejay Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Novotech Clinical Research (Cyprus) Limited
- Responsibilities
- codes/roles provided in record: 1,10,11,12,2,5,6,8
- Name
- Link Medical Research AS
- Responsibilities
- codes/roles provided in record: 1,12
- Name
- Evidenze Health S.r.l.
- Responsibilities
- code/role provided in record: 12
Third parties
- {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"Storage Specimens","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"codes: 3,7","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Australia","full_name":"Resolian","duties_or_roles":"code: 4","organisation_type":"Industry"}
- {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"Storage; code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Netherlands","full_name":"DDL Diagnostic Laboratory B.V.","duties_or_roles":"Storage Specimens; code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"Central Laboratory services","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Australia","full_name":"Sonic Clinical Trials Pty Limited","duties_or_roles":"Storage, shipping; code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Acm Medical Laboratory Inc.","duties_or_roles":"Storage","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Australia","full_name":"VIDRL","duties_or_roles":"code: 4","organisation_type":"Health care"}
- {"country":"United States","full_name":"B2s Life Sciences LLC","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Evidenze Health S.r.l.","duties_or_roles":"code: 12","organisation_type":"Pharmaceutical company"}
- {"country":"Cyprus","full_name":"Novotech Clinical Research (Cyprus) Limited","duties_or_roles":"codes: 1,10,11,12,2,5,6,8","organisation_type":"Pharmaceutical company"}
- {"country":"Norway","full_name":"Link Medical Research AS","duties_or_roles":"codes: 1,12","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- BJT-778
- Active Substance
- BJT-778
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Maximum Dose
- 300 mg
- Investigational Product Name
- BULEVIRTIDE
- Active Substance
- BULEVIRTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- prodAuthStatus: 2
- Orphan Designation
- Yes
- Maximum Dose
- 2 mg
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