Clinical trial • Phase II/III • Infectious Disease|Rare Disease
BJT-778 for Chronic Hepatitis D Infection|Hepatitis D
Phase II/III trial of BJT-778 for Chronic Hepatitis D Infection|Hepatitis D.
Overview
- Trial Therapeutic Area
- Infectious Disease|Rare Disease
- Trial Disease
- Chronic Hepatitis D Infection|Hepatitis D
- Trial Stage
- Phase II/III
- Drug Modality
- Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 30-09-2025
- First CTIS Authorization Date
- 03-02-2026
Trial design
open-label, bulevirtide (bulevirtide) — solution for injection; route: subcutaneous injection; reported max daily dose: 2 mg (max total dose amount 336 mg; product role: comparator).-controlled Phase II/III trial across 41 sites in Czechia, France, Italy and others.
- Open Label
- Yes
- Comparator
- Bulevirtide (BULEVIRTIDE) — solution for injection; route: subcutaneous injection; reported max daily dose: 2 mg (max total dose amount 336 mg; product role: Comparator).
- Target Sample Size
- 115
- Trial Duration For Participant
- 672
Eligibility
Recruits 115 No vulnerable populations selected; participants must be ≥18 years of age and must be "Willing and able to provide written informed consent." Informed consent (subject information and ICF) documents are provided for participating countries and languages; assent not applicable..
- Pregnancy Exclusion
- 1. Pregnant or nursing females
- Vulnerable Population
- No vulnerable populations selected; participants must be ≥18 years of age and must be "Willing and able to provide written informed consent." Informed consent (subject information and ICF) documents are provided for participating countries and languages; assent not applicable.
Inclusion criteria
- {"criterion_text":"- 1. Willing and able to provide written informed consent."}
- {"criterion_text":"- 2. Male or female, ≥18 years of age at Screening."}
- {"criterion_text":"- 3. Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study."}
- {"criterion_text":"- 4. Currently taking bulevirtide treatment for CHD for ≥ 6 months at the time of Screening."}
- {"criterion_text":"- 5. HDV RNA ≥ 100 IU/mL at Screening"}
Exclusion criteria
- {"criterion_text":"- 1. Pregnant or nursing females"}
- {"criterion_text":"- 9. Treatment with an investigational drug, a biological agent, or device within 4 weeks or 5 half-lives, whichever is longer, of baseline."}
- {"criterion_text":"- 10. Treatment with any interferon within 12 weeks of screening"}
- {"criterion_text":"- 11. History or suspected non-compliance with bulevirtide treatment as evaluated by the Investigator."}
- {"criterion_text":"- 12. Use of any prohibited concomitant medications as described in Section 7.8"}
- {"criterion_text":"- 13. Regular alcohol misuse, defined as weekly intake of ≥14 drinks per week (average of ≥2 drinks per day) within 12 months of Screening"}
- {"criterion_text":"- 14. Clinically relevant drug abuse (not including cannabis) within 12 months of Screening"}
- {"criterion_text":"- 15. Unwillingness to comply with study procedures as specified by this protocol, or unwillingness to cooperate fully with the Investigator"}
- {"criterion_text":"- 16. 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"}
- {"criterion_text":"- 2. Male or female participants of childbearing potential unwilling to comply with contraception requirements during the study (Appendix 4)."}
- {"criterion_text":"- 3. Current, prior history, or is under evaluation for any of the following: a) Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy. b) Clinical hepatic decompensation (i.e., ascites, encephalopathy, variceal hemorrhage). Incidental small ascites on imaging without other clinical symptoms/signs of acute decompensation would not exclude the participants. Prior history of hepatic decompensation may be allowed if the event occurred ≥12 months from screening. c) HCC or suspicion of HCC on ultrasound at Screening d) Vasculitis"}
- {"criterion_text":"- 3. e) Extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa) f) Solid organ or bone marrow transplantation. g) Significant pulmonary disease (e.g., O2-dependent or FEV1 ≤50% predicted value) h) Significant 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) Malignancy 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 before screening; breast cancer or prostate cancer on anti-hormonal therapy)."}
- {"criterion_text":"- 4. CTP >6 (B or C) (see Section 6.7.7.2)"}
- {"criterion_text":"- 5. Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or HAV) 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 was successfully treated (HCV RNA negative) ≥6 months before screening."}
- {"criterion_text":"- 6. Uncontrolled HIV infection defined as having quantifiable HIV RNA levels in the blood at Screening"}
- {"criterion_text":"- 7. History of hypersensitivity to any of the components in the brelovitug formulation"}
- {"criterion_text":"- 8. Screening laboratory results as follows, or any other clinically significant abnormalities in Screening laboratory values that would render a participant unsuitable for inclusion: a) Platelet count <50,000/mm3 b) Hemoglobin <10.0 g/dL c) Creatinine clearance by Cockcroft-Gault (CrCl) <50 mL/min d) Alpha fetoprotein (AFP) >100 ng/mL"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The proportion of participants who achieve: • Undetectable HDV RNA (< LLOQ, target not detected [TND])","definition_or_measurement_approach":"Undetectable HDV RNA defined as < LLOQ, target not detected (TND) as stated."}
Secondary endpoints
- {"endpoint_text":"- Safety endpoints will evaluate: • Incidence and severity of treatment-emergent adverse events (TEAE) • Proportion of participants who permanently discontinue treatment due to an adverse event • Change from baseline of serum total bile salts Comparison with bulevirtide will include data through 24 weeks.","definition_or_measurement_approach":"Safety measured by incidence and severity of TEAEs; proportion permanently discontinuing due to AE; change from baseline in serum total bile salts; comparison with bulevirtide includes data through 24 weeks."}
- {"endpoint_text":"- The proportion of participants who achieve the following at Weeks 24, 48, 72, and 96 of treatment unless otherwise specified: • Virologic response defined as HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND • HDV RNA < LLOQ • HDV RNA < LLOQ, TND (Weeks 48, 72, and 96)","definition_or_measurement_approach":"Virologic response defined as HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND; assessments at Weeks 24, 48, 72, 96."}
- {"endpoint_text":"- • Normal ALT alone and in combination with: − Virologic response defined as HDV RNA ≥ 2 log10 IU/mL decline from baseline or HDV RNA < LLOQ, TND − HDV RNA < LLOQ − HDV RNA < LLOQ, TND • Change from baseline of HDV RNA • Change from baseline of ALT Comparison with bulevirtide will include data through 24 weeks","definition_or_measurement_approach":"ALT normalization alone and combined with virologic response endpoints; changes from baseline in HDV RNA and ALT; comparison with bulevirtide includes data through 24 weeks."}
- {"endpoint_text":"- • Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up Weeks 24 and 48","definition_or_measurement_approach":"Proportion achieving HDV RNA < LLOQ, TND at post-treatment follow-up Weeks 24 and 48."}
Recruitment
- Planned Sample Size
- 115
- Recruitment Window Months
- 37
- Consent Approach
- Written informed consent is required from each participant: participants must be ≥18 and "Willing and able to provide written informed consent." Subject information sheets and ICFs are provided (published) in country languages (examples in documents: CZ, FR, ES, IT, RO, DE, EN). No assent procedures (no minors included).
Methods
- Patient poster (K2_Recruitment material_Patient poster) — recruitment channel: posters targeted at potential participants; country-specific versions present.
- Participant brochure (K2_Recruitment material_Patient brochure / Participant Brochure) — recruitment channel: informational brochures for potential participants; country-specific versions present.
- Doctor-to-doctor referral letter template (K2_Dr-Dr Referral Letter Template) — recruitment channel: physician referral pathway for identifying eligible patients via clinicians.
- K1_Recruitment arrangement documents — site-level recruitment arrangements as provided in K1_Recruitment arrangement files (country-specific).
Geography
- Total Number Of Sites
- 41
- Total Number Of Participants
- 115
Czechia
- Earliest CTIS Part Ii Submission Date
- 09-01-2026
- Latest Decision Or Authorization Date
- 04-02-2026
- Processing Time Days
- 26
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- 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
- petr.urbanek@uvn.cz
- Contact Person Name
- Petr Urbánek
- Contact Person Email
- petr.urbanek@uvn.cz
- 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
France
- Earliest CTIS Part Ii Submission Date
- 04-11-2025
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 149
- Number Of Sites
- 14
- Number Of Participants
- 25
Sites
- Site Name
- Centre Hospitalier Intercommunal Creteil
- Department Name
- Service de gastroentérologie et hépatologie
- 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
- Hôpital de la Croix- Rousse Service d’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 Universitaire De Montpellier
- Department Name
- Hôpital St Eloi Service d’Hépato-Gastroentérologie et transplantation
- Principal Investigator Name
- Magdalena MESZAROS
- Principal Investigator Email
- m-meszaros@chumontpellier.fr
- Contact Person Name
- Magdalena MESZAROS
- Contact Person Email
- m-meszaros@chumontpellier.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Service 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
- 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
- Centre Hospitalier Universitaire De Rennes
- Department Name
- Service 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 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
- Assistance Publique Hopitaux De Paris (Clichy)
- Department Name
- Hôpital Beaujon - Service d’Hépatologie – 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
- University Hospital Of Clermont-Ferrand
- Department Name
- Hôpital Estaing - Service 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
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Hôpital Nord Michallon - Service 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
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Hôpital Rangueil - Service d’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
- Assistance Publique Hopitaux De Paris (Creteil)
- Department Name
- Hôpital Henri-Mondor - Service d’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
- 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
- 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
Italy
- Earliest CTIS Part Ii Submission Date
- 09-01-2026
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 102
- Number Of Sites
- 5
- Number Of Participants
- 25
Sites
- 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
- Humanitas Mirasole S.p.A.
- 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
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Gastroenterology
- Principal Investigator Name
- Alessandro Loglio
- Principal Investigator Email
- aloglio@asst-pg23.it
- Contact Person Name
- Alessandro Loglio
- Contact Person Email
- aloglio@asst-pg23.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
- University Of Parma
- Department Name
- Infectious Diseases, Gastroenterology
- Principal Investigator Name
- Gabriele Missale
- Principal Investigator Email
- gabriele.missale@unipr.it
- Contact Person Name
- Gabriele Missale
- Contact Person Email
- gabriele.missale@unipr.it
Romania
- Earliest CTIS Part Ii Submission Date
- 15-01-2026
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 84
- Number Of Sites
- 6
- Number Of Participants
- 20
Sites
- Site Name
- Institutul Clinic Fundeni
- Department Name
- Internal Medicine II Clinic
- Principal Investigator Name
- Laura Elena Iliescu
- Principal Investigator Email
- secretariat@icfundeni.ro
- Contact Person Name
- Laura Elena Iliescu
- Contact Person Email
- secretariat@icfundeni.ro
- Site Name
- Institutul National De Boli Infectioase Prof.Dr.Matei Bals
- Department Name
- Infectious Diseases II - Adults
- Principal Investigator Name
- Liliana Lucia Preotescu
- Principal Investigator Email
- anca.streinucercel@gmail.com
- Contact Person Name
- Liliana Lucia Preotescu
- Contact Person Email
- anca.streinucercel@gmail.com
- Site Name
- Institutul National De Boli Infectioase Prof.Dr.Matei Bals (duplicate site entry)
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Oana Sandulescu
- Principal Investigator Email
- anca.streinucercel@gmail.com
- Contact Person Name
- Oana Sandulescu
- Contact Person Email
- anca.streinucercel@gmail.com
- Site Name
- Centrul Medical Unirea S.R.L.
- Department Name
- Infectious Diseases
- 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 Si Tropicale Dr. Victor Babes
- Department Name
- Infectious and Tropical Diseases
- Principal Investigator Name
- Corneliu Petru Popescu
- Principal Investigator Email
- office@spitalulbabes.ro
- Contact Person Name
- Corneliu Petru Popescu
- Contact Person Email
- office@spitalulbabes.ro
- Site Name
- Spitalul Clinic De Boli Infectioase Constanta
- Department Name
- Infectious Diseases II
- Principal Investigator Name
- Irina Magdalena Dumitru
- Principal Investigator Email
- roxana.cernat@seanet.ro
- Contact Person Name
- Irina Magdalena Dumitru
- Contact Person Email
- roxana.cernat@seanet.ro
Spain
- Earliest CTIS Part Ii Submission Date
- 12-01-2026
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 94
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Internal medicine/Hepatology
- 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 Ramon Y Cajal
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Agustin Albillos Martinez
- Principal Investigator Email
- agustin.albillios@uah.es
- Contact Person Name
- Agustin Albillos Martinez
- Contact Person Email
- agustin.albillios@uah.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Gastroenterology Department
- 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 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
Germany
- Earliest CTIS Part Ii Submission Date
- 12-01-2026
- Latest Decision Or Authorization Date
- 09-04-2026
- Processing Time Days
- 87
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- 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
- 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
- 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
- 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
- ICH Study Center GmbH & Co. KG
- Department Name
- Infectious diseases
- Principal Investigator Name
- Michael Sabranski
- Principal Investigator Email
- sabranski@ich-studycenter.com
- Contact Person Name
- Michael Sabranski
- Contact Person Email
- sabranski@ich-studycenter.com
Austria
- Earliest CTIS Part Ii Submission Date
- 28-01-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 103
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Medical University Of Vienna
- Department Name
- Department of InternalMedicine I
- Principal Investigator Name
- Thomas Reiberger
- Principal Investigator Email
- thomas.reiberger@meduniwein.ac.at
- Contact Person Name
- Thomas Reiberger
- Contact Person Email
- thomas.reiberger@meduniwein.ac.at
- Site Name
- Universitatsklinikum St. Polten
- Department Name
- 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 Innsbruck
- Department Name
- Innere Medizin 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
- Site Name
- Medizinische Universität 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
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
- sponsorDuties codes: ["1","11","12","2","5","6","8"]
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties codes: ["3","7"]
Third parties
- {"country":"United States","full_name":"B2s Life Sciences LLC","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"Central Laboratory services (sponsorDuties code: 15)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Netherlands","full_name":"DDL Diagnostic Laboratory B.V.","duties_or_roles":"Storage Specimens; sponsorDuties codes: [\"15\",\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Australia","full_name":"Resolian","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Industry"}
- {"country":"Cyprus","full_name":"Novotech Clinical Research (Cyprus) Limited","duties_or_roles":"sponsorDuties codes: [\"1\",\"11\",\"12\",\"2\",\"5\",\"6\",\"8\"]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Acm Medical Laboratory Inc.","duties_or_roles":"Storage (sponsorDuties code: 15); also code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Australia","full_name":"VIDRL","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Health care"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [\"3\",\"7\"]","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"Storage (sponsorDuties code: 15); also code: 4","organisation_type":"Laboratory/Research/Testing facility"}
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
- Investigational (MIA number DE_BW_01_MIA_2024_0081)
- Orphan Designation
- Yes
- Maximum Dose
- 300 mg (maxDailyDoseAmount)
- Investigational Product Name
- BULEVIRTIDE
- Active Substance
- BULEVIRTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised (SmPC documents available)
- Orphan Designation
- Yes
- Maximum Dose
- 2 mg (maxDailyDoseAmount)
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