Clinical trial • Phase II • Cardiology
AB-1002 for Congestive heart failure | Non-ischaemic cardiomyopathy
Phase II trial of AB-1002 for Congestive heart failure | Non-ischaemic cardiomyopathy.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Congestive heart failure | Non-ischaemic cardiomyopathy
- Trial Stage
- Phase II
- Drug Modality
- Gene therapy
Key dates
- Initial CTIS Submission Date
- 16-05-2024
- First CTIS Authorization Date
- 10-09-2024
Trial design
Randomised, placebo infusion (ab-1002 placebo) administered as comparator to single antegrade intracoronary infusion of ab-1002; specific dose and schedule not specified in the provided record.-controlled, adaptive Phase II trial in Hungary, Bulgaria, Romania and others.
- Randomised
- Yes
- Comparator
- Placebo infusion (AB-1002 Placebo) administered as comparator to single antegrade intracoronary infusion of AB-1002; specific dose and schedule not specified in the provided record.
- Adaptive
- True, adaptive design is stated (Phase 2 adaptive). No detailed adaptive elements (e.g., explicit dose-escalation rules, interim analysis timing, or stopping rules) are described in the provided record.
- Target Sample Size
- 80
- Trial Duration For Participant
- 364
Eligibility
Recruits 80 Vulnerable population selected. Participants must be adults (≥18 years) and provide informed consent. Country-specific subject information and informed consent forms are provided (multiple languages/countries). No mention of assent for minors (minors are excluded)..
- Pregnancy Exclusion
- Pregnancy or breastfeeding or plans to become pregnant within the next 12 months at the time of screening
- Vulnerable Population
- Vulnerable population selected. Participants must be adults (≥18 years) and provide informed consent. Country-specific subject information and informed consent forms are provided (multiple languages/countries). No mention of assent for minors (minors are excluded).
Inclusion criteria
- {"criterion_text":"- Subject must be age ≥18 years of age, at the time of signing the informed consent\n- Chronic non-ischemic cardiomyopathy\n- 15% ≤ LVEF ≤ 35% by transthoracic echocardiography (TTE) at screening\n- 6MWT >50 meters\n- Medically stable, NYHA Class III HF for a minimum of 4 weeks while on appropriate medical therapy (defined below) including, but not limited to: a.\tAngiotensin-converting enzyme inhibitor (ACE-I), angiotensin receptor-neprilysin inhibitor (ARNI), angiotensin receptor blocker (ARB), sacubitril/valsartan combination therapy (Entresto), beta blocker therapy, mineralocorticoid receptor antagonist (MRA), sodium-glucose co-transporter 2 inhibitor (SGLT2i) for ≥ 90 days prior to enrollment. Doses of the above medications must be stable for ≥ 30 days prior to enrollment. b.\tCardiac resynchronization therapy (Zareba et al., 2011), if clinically indicated, must have been implanted ≥ 90 days prior to enrollment. ICD must be implanted, if clinically indicated ≥ 30 days prior to enrollment.\n- Women of childbearing potentia (for definition see also Section 9.4.1)l must use at least one of the following highly effective birth control methods throughout the study: - Intrauterine device in place at least 90 days prior receiving SI - Abstinence (the subject must be willing to remain abstinent from screening to 6 months after receiving SI). Females are allowed to claim abstinence as their method of contraception only when it is the preferred and usual lifestyle of the subject - Surgical sterilization of the partner(s) (vasectomy) for >180 days prior to SI administration - Hormonal contraceptives associated with the inhibition of ovulation starting > 90 days prior to SI. If hormonal contraceptives are started less than 90 days prior to receiving SI, subjects must agree to use a barrier method (diaphragm plus spermicide or condom) from screening through 90 days after initiation of hormonal contraceptives\n- Males subjects capable of fathering a child: - Must agree not to donate sperm for 6 months (in Belgium: 12 months) after time of receiving SI - Documented evidence of vasectomy in males for 180 days minimum prior to receiving SI is an acceptable form of contraception - Males who claim abstinence as their method of contraception are allowed, provided they agree to use barrier methods should they become sexually active from screening through 6 months (in Belgium: 12 months) after receiving IP. Males are allowed to claim abstinence as their method of contraception only when it is the preferred and usual lifestyle of the subject\n- Appropriate candidate for protocol-specified intracoronary infusion in the judgment of the infusing interventional cardiologist\n- To protect partners of study subjects from potential viral shedding, sexually active subjects and their partners must agree to use barrier methods of contraception (condoms, female condoms, and dams) for a minimum of 6 months (in Belgium: 12 months) after SI administration; barrier methods should be used regardless of any other applied birth control methods."}
Exclusion criteria
- {"criterion_text":"- Chronic ischemic cardiomyopathy secondary to obstructive coronary artery disease\n- known hypersensivity to SI or to any of the exipients or to the placebo\n- Expected survival < 1 year in the judgment of the investigator\n- Clinicially relevant infection 48 hours prior to intracoronary infusion\n- Known intrinsic liver disease (e.g., cirrhosis, hepatitis A, chronic hepatitis B or hepatitis C virus infection). If serology is positive and polymerase chain reaction (PCR) is known to be negative, the subject may be eligible (confirm with medical monitor)\n- Liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase or total bilirubin) > 2x upper limit of normal (ULN) within 30 days prior to enrollment. In the case that patients have a confirmed diagnosis of benign liver dysfunction (e.g. Gilbert’s syndrome with unconjugated bilirubin not exceeding 4 mg/dL), patients may be eligible for inclusion into the study).\n- Chronic Kidney Disease Stage 5, dialysis dependent or eGFR<15 within 30 days prior to enrollment\n- Bleeding diathesis or thrombocytopenia defined as platelets <50,000 platelets/μL within 30 days prior to enrollment\n- Anemia is defined as hemoglobin <10 g/dL or transfusion dependent within 30 days prior to enrollment\n- Neutropenia is defined as absolute neutrophils <1500 mm3 within 30 days prior to enrollment\n- Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an absolute neutrophil count <1000 cells/mm3\n- Intravenous (IV) inotropic therapy, intra-aortic balloon pump (IABP) or percutaneous cardiac assist device therapy within 30 days prior to enrollment\n- Previous participation in a study of gene transfer\n- Receiving investigational intervention or participating in another clinical study within 30 days of another investigational drug administration prior to administration of AB-1002 that may impact the therapeutic potential of AB-1002\n- Pregnancy or breastfeeding or plans to become pregnant within the next 12 months at the time of screening\n- Subjects with any other condition which in the opinion of the investigator would preclude participation in the study (including risk for noncompliance and any intercurrent conditions that pose an undue medical hazard, or which could interfere with the interpretation of the study results)\n- Malignant neoplasm within 5 years of dosing, with the exception of those with negligible risk of metastasis or death (such as adequately treated carcinoma in situs of the cervix, basal or squamous cell skin cancer, localized prostate cancer or ductal carcinoma in situ)\n- Any documented history of noncompliance with medications; illicit drug use or laboratory evidence of illicit drug use during screen period\n- Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic LV aneurysm\n- Cardiac surgery or PCI within 30 days prior to enrollment\n- Uncorrected third degree heart block\n- Clinically significant MI in the judgment of the subject’s physician (e.g., ST elevation MI [STEMI] or large non-STEMI) within 6 months prior to enrollment\n- Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), surgically implanted LVAD or cardiac shunt\n- Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LV reduction surgery, heart transplant, conventional revascularization procedure, or valvular repair within 3 months of SI dosing in the judgment of the investigator\n- Known hypersensitivity to contrast dyes (not easily controlled by antihistamines) used for angiography; history of, or likely need for, high dose steroid pretreatment prior to contrast angiography"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Modified Win Ratio at 52-weeks as defined by hierarchical evaluation of the following assessments in the given order: - Cardiovascular related death (Binary) - NYHA Classification change from baseline (Ordinal) - LVEF change from baseline (Binary, >=5% increase for responders) - six-minute walk test (6MWT) change from baseline (Binary >30m increase for responders)","definition_or_measurement_approach":"Modified Win Ratio at 52 weeks defined by hierarchical evaluation: (1) cardiovascular related death (binary); (2) NYHA classification change from baseline (ordinal); (3) LVEF change from baseline (binary; responder if >=5% increase); (4) 6MWT change from baseline (binary; responder if >30m increase)."}
- {"endpoint_text":"- The safety endpoints will be assessed over the 52-week Observation Period as indicated in the Schedule of Activities: - Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) - Observed value and change from baseline in clinical laboratory tests - Observed value and change from baseline in vital signs - Observed value and change from baseline in electrocardiograms (ECGs)","definition_or_measurement_approach":"Safety endpoints assessed over 52-week observation: collection and assessment of treatment-emergent AEs and SAEs; observed values and change from baseline in clinical laboratory tests, vital signs, and ECGs as per schedule of activities."}
Secondary endpoints
- {"endpoint_text":"- Cardiovascular related death","definition_or_measurement_approach":"Event of cardiovascular-related death as recorded during follow-up."}
- {"endpoint_text":"- Functional Status and Hospitalizations at 24 and 52 weeks","definition_or_measurement_approach":"Assessment of functional status and recording of hospitalizations at 24 and 52 weeks."}
- {"endpoint_text":"- Observed value and change from baseline in NYHA Classification","definition_or_measurement_approach":"NYHA classification recorded and compared to baseline."}
- {"endpoint_text":"- Observed value and change from baseline in LVEF","definition_or_measurement_approach":"Left ventricular ejection fraction measured (echocardiography) and change from baseline evaluated."}
- {"endpoint_text":"- Observed value and change from baseline in 6MWT","definition_or_measurement_approach":"Six-minute walk test distance measured and change from baseline evaluated."}
- {"endpoint_text":"- Number of HF hospitalizations","definition_or_measurement_approach":"Count of heart failure-related hospital admissions during follow-up."}
- {"endpoint_text":"- Time to first HF hospitalization","definition_or_measurement_approach":"Time (e.g., days) from randomization to first heart failure hospitalization."}
- {"endpoint_text":"- Physiologic Assessments","definition_or_measurement_approach":"Physiologic assessments as defined in schedule (unspecified in summary)."}
- {"endpoint_text":"- Observed value and change from baseline in Echocardiographic assessments of: - LVEF (at 4, 12 and 36 weeks) - LV volumes: end systolic and end diastolic volumes - LVEDV and left ventricular end diastolic index (LVEDVI) - LVESV and LVESVI - sphericity index (SpI) - GLS and - degree of mitral regurgitation","definition_or_measurement_approach":"Echocardiographic measures (LVEF at weeks 4, 12, 36; LV volumes; LVEDV/LVEDVI; LVESV/LVESVI; sphericity index; global longitudinal strain (GLS); mitral regurgitation grade) and change from baseline."}
- {"endpoint_text":"- Observed value and change from baseline in cardiac biomarker NT-proBNP","definition_or_measurement_approach":"NT-proBNP concentration measured and change from baseline recorded."}
- {"endpoint_text":"- Observed value and change from baseline in the KCCQ as assessed by a 15-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity, and recent change), social function, self-efficacy and knowledge, and QOL","definition_or_measurement_approach":"Kansas City Cardiomyopathy Questionnaire (KCCQ) 15-item self-administered score and change from baseline."}
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 72
- Consent Approach
- Informed consent is required from each participant (must be ≥18 years). Country-specific subject information and informed consent form (ICF) documents are provided in multiple languages/countries (examples: HU, BG, RO, PL, DE, NL, ES, BE). Additional ICFs address pregnancy information, biopsy/heart tissue donation, and study updates. No assent procedures for minors are provided (minors excluded).
Methods
- Use of site-level recruitment materials (flyers, patient brochures, gene therapy sheets) and patient-facing materials (tabletop flip charts, visit schemes) tailored by country (documents listed for HU, BG, RO, PL, AT, DE, NL, ES, BE).
- Use of multimedia materials (gene therapy video and storyboard) for patient information and recruitment (country-specific video/storyboard documents present).
- Site recruitment procedures and templates (K1 Recruitment arrangements / Procedure Template) for country-specific recruitment and ICF procedure (documents exist for multiple countries).
Geography
- Total Number Of Sites
- 54
- Total Number Of Participants
- 243
Hungary
- Earliest CTIS Part Ii Submission Date
- 18-11-2024
- Latest Decision Or Authorization Date
- 11-12-2024
- Processing Time Days
- 23
- Number Of Sites
- 6
- Number Of Participants
- 38
Sites
- Site Name
- Semmelweis University
- Department Name
- Varosmajori Sziv- es Ergyogyaszati Klinika
- Principal Investigator Name
- Bela Peter Merkely
- Principal Investigator Email
- merkely.bela@kardio.sote.hu
- Contact Person Name
- Bela Peter Merkely
- Contact Person Email
- merkely.bela@kardio.sote.hu
- Site Name
- Central Hospital Of Northern Pest Military Hospital
- Department Name
- Kardiologiai Osztaly
- Principal Investigator Name
- Gabor Zoltan Duray
- Principal Investigator Email
- duray.gabor@epc-honvedkorhaz.hu
- Contact Person Name
- Gabor Zoltan Duray
- Contact Person Email
- duray.gabor@epc-honvedkorhaz.hu
- Site Name
- University Of Szeged
- Department Name
- Belgyogyaszati Klinika
- Principal Investigator Name
- Tamas Szili-Torok
- Principal Investigator Email
- szili-torok.tamas@med.u-szeged.hu
- Contact Person Name
- Tamas Szili-Torok
- Contact Person Email
- szili-torok.tamas@med.u-szeged.hu
- Site Name
- University Of Pecs
- Department Name
- Szivgyogyaszati Klinika, Intervencios Kardiologia
- Principal Investigator Name
- Ivan Gabor Horvath
- Principal Investigator Email
- ivan.g.horvath@pte.hu
- Contact Person Name
- Ivan Gabor Horvath
- Contact Person Email
- ivan.g.horvath@pte.hu
- Site Name
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
- Department Name
- Kardiologiai Osztaly, Klinikai Vizsgalati Egyseg
- Principal Investigator Name
- Andras Vorobcsuk
- Principal Investigator Email
- vorobcsuk.andras@kmmk.hu
- Contact Person Name
- Andras Vorobcsuk
- Contact Person Email
- vorobcsuk.andras@kmmk.hu
- Site Name
- Budapesti Uzsoki Utcai Korhaz
- Department Name
- Kardiologiai Osztaly
- Principal Investigator Name
- Balazs Sarman
- Principal Investigator Email
- sarman.balazs@uzsoki.hu
- Contact Person Name
- Balazs Sarman
- Contact Person Email
- sarman.balazs@uzsoki.hu
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 06-08-2025
- Latest Decision Or Authorization Date
- 21-08-2025
- Processing Time Days
- 15
- Number Of Sites
- 9
- Number Of Participants
- 30
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
- Department Name
- Department of Invasive Cardiology at Clinic of Cardiology
- Principal Investigator Name
- Ivan Martinov
- Principal Investigator Email
- pirogov@pirogov.bg
- Contact Person Name
- Ivan Martinov
- Contact Person Email
- pirogov@pirogov.bg
- Site Name
- South West Hospital Ltd.
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Boris Zehirov
- Principal Investigator Email
- mbal_st_vrach@abv.bg
- Contact Person Name
- Boris Zehirov
- Contact Person Email
- mbal_st_vrach@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Sofiamed OOD
- Department Name
- Clinic of Cardiology
- Principal Investigator Name
- Iveta Tasheva
- Principal Investigator Email
- hospitalsofiamed@bulpharma.bg
- Contact Person Name
- Iveta Tasheva
- Contact Person Email
- hospitalsofiamed@bulpharma.bg
- Site Name
- University Multidisciplinary Hospital For Active Treatment Sveta Ekaterina EAD
- Department Name
- Clinic of Cardiology
- Principal Investigator Name
- Diana Trendafilova - Lazarova
- Principal Investigator Email
- info@uhsek.com
- Contact Person Name
- Diana Trendafilova - Lazarova
- Contact Person Email
- info@uhsek.com
- Site Name
- Мultidisciplinary hospital for active treatment Saint George Pernik OOD
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Kostadin Kichukov
- Principal Investigator Email
- sbalk.svetigeorgi@gmail.com
- Contact Person Name
- Kostadin Kichukov
- Contact Person Email
- sbalk.svetigeorgi@gmail.com
- Site Name
- Specialized Hospital For Active Cardiology Treatement Cardiolife OOD
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Trayan Tsvetkov
- Principal Investigator Email
- mbal_kardiolife@abv.bg
- Contact Person Name
- Trayan Tsvetkov
- Contact Person Email
- mbal_kardiolife@abv.bg
- Site Name
- Specialized Hospital For Active Cardiology Treatment Medica Kor EAD
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Dobrin Vasilev
- Principal Investigator Email
- info@medica-core.com
- Contact Person Name
- Dobrin Vasilev
- Contact Person Email
- info@medica-core.com
- Site Name
- MHAT National Heart Hospital EAD
- Department Name
- Clinic of Cardiology
- Principal Investigator Name
- Alexander Alexandrov
- Principal Investigator Email
- nkb@hearthospital.bg
- Contact Person Name
- Alexander Alexandrov
- Contact Person Email
- nkb@hearthospital.bg
- Site Name
- Acibadem City Clinic Tokuda University Hospital EAD
- Department Name
- Clinic of Cardiology
- Principal Investigator Name
- Valeri Gelev
- Principal Investigator Email
- tcrc@acibademcityclinic.bg
- Contact Person Name
- Valeri Gelev
- Contact Person Email
- tcrc@acibademcityclinic.bg
Romania
- Earliest CTIS Part Ii Submission Date
- 23-06-2025
- Latest Decision Or Authorization Date
- 25-08-2025
- Processing Time Days
- 63
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Institutul De Boli Cardiovasculare Timisoara
- Department Name
- Cardiology
- Principal Investigator Name
- Dan Gaita
- Principal Investigator Email
- office@cardiologie.ro
- Contact Person Name
- Dan Gaita
- Contact Person Email
- office@cardiologie.ro
- Site Name
- Spitalul Clinic Judetean De Urgenta Targu Mures
- Department Name
- Cardiology
- Principal Investigator Name
- Theodora Benedek
- Principal Investigator Email
- secretariat@spitalmures.ro
- Contact Person Name
- Theodora Benedek
- Contact Person Email
- secretariat@spitalmures.ro
- Site Name
- Spitalul Clinic Judetean De Urgenta Brasov
- Department Name
- Cardiology
- Principal Investigator Name
- Florin Ortan
- Principal Investigator Email
- secretariat@spitaluljudeteanbrasov.ro
- Contact Person Name
- Florin Ortan
- Contact Person Email
- secretariat@spitaluljudeteanbrasov.ro
- Site Name
- Spitalul Universitar De Urgenta Bucuresti
- Department Name
- Cardiology
- Principal Investigator Name
- Dragos Vinereanu
- Principal Investigator Email
- secretariat@suub.ro
- Contact Person Name
- Dragos Vinereanu
- Contact Person Email
- secretariat@suub.ro
- Site Name
- Spitalul Clinic Judetean De Urgenta Craiova
- Department Name
- Cardiology
- Principal Investigator Name
- Constantin Militaru
- Principal Investigator Email
- info@scjuc.ro
- Contact Person Name
- Constantin Militaru
- Contact Person Email
- info@scjuc.ro
- Site Name
- Spitalul Clinic Judetean De Urgenta Militar Central Dr. Carol Davila
- Department Name
- Cardiology
- Principal Investigator Name
- Silviu Dumitrescu
- Principal Investigator Email
- secretariat@scumc.ro
- Contact Person Name
- Silviu Dumitrescu
- Contact Person Email
- secretariat@scumc.ro
Poland
- Earliest CTIS Part Ii Submission Date
- 22-07-2025
- Latest Decision Or Authorization Date
- 22-08-2025
- Processing Time Days
- 31
- Number Of Sites
- 9
- Number Of Participants
- 25
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Cardiology
- Principal Investigator Name
- Michał Tomaszewski
- Principal Investigator Email
- cwbk@umlub.pl
- Contact Person Name
- Michał Tomaszewski
- Contact Person Email
- cwbk@umlub.pl
- Site Name
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Department Name
- Cardiology
- Principal Investigator Name
- Przemyslaw Leszek
- Principal Investigator Email
- kns@ikard.pl
- Contact Person Name
- Przemyslaw Leszek
- Contact Person Email
- kns@ikard.pl
- Site Name
- American Heart Of Poland S.A. (Chrzanow)
- Department Name
- Cardiology
- Principal Investigator Name
- Aleksander Zurakowski
- Principal Investigator Email
- clinicaltrial@ahop.pl
- Contact Person Name
- Aleksander Zurakowski
- Contact Person Email
- clinicaltrial@ahop.pl
- Site Name
- 1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie
- Department Name
- Cardiology
- Principal Investigator Name
- Grzegorz Sobieszek
- Principal Investigator Email
- cwbk@1wszk.pl
- Contact Person Name
- Grzegorz Sobieszek
- Contact Person Email
- cwbk@1wszk.pl
- Site Name
- American Heart Of Poland S.A. (Bielsko-Biala)
- Department Name
- Cardiology
- Principal Investigator Name
- Krzysztof Milewski
- Principal Investigator Email
- clinicaltrial@ahop.pl
- Contact Person Name
- Krzysztof Milewski
- Contact Person Email
- clinicaltrial@ahop.pl
- Site Name
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- Cardiology
- Principal Investigator Name
- Krzysztof Golba
- Principal Investigator Email
- ekk@gcm.pl
- Contact Person Name
- Krzysztof Golba
- Contact Person Email
- ekk@gcm.pl
- Site Name
- American Heart Of Poland S.A. (Tychy)
- Department Name
- Cardiology
- Principal Investigator Name
- Adam Janas
- Principal Investigator Email
- clinicaltrial@ahop.pl
- Contact Person Name
- Adam Janas
- Contact Person Email
- clinicaltrial@ahop.pl
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Cardiology
- Principal Investigator Name
- Grzegorz Kopec
- Principal Investigator Email
- sekr_kard@szpitaljp2.krakow.pl
- Contact Person Name
- Grzegorz Kopec
- Contact Person Email
- sekr_kard@szpitaljp2.krakow.pl
- Site Name
- Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
- Department Name
- Cardiology
- Principal Investigator Name
- Grzegorz Skonieczny
- Principal Investigator Email
- kardiologia@wszz.torun.pl
- Contact Person Name
- Grzegorz Skonieczny
- Contact Person Email
- kardiologia@wszz.torun.pl
Austria
- Earliest CTIS Part Ii Submission Date
- 26-06-2024
- Latest Decision Or Authorization Date
- 15-09-2024
- Processing Time Days
- 81
- Number Of Sites
- 4
- Number Of Participants
- 25
Sites
- Site Name
- Medical University Of Graz
- Department Name
- Universitaetsklinik fuer Innere Medizin, Klin. Abt. fuer Kardiologie
- Principal Investigator Name
- Markus Wallner
- Principal Investigator Email
- markus.wallner@medunigraz.at
- Contact Person Name
- Markus Wallner
- Contact Person Email
- markus.wallner@medunigraz.at
- Site Name
- Noe LGA Gesundheit Region Mitte GmbH
- Department Name
- Innere Med III
- Principal Investigator Name
- Deddo Moertl
- Principal Investigator Email
- deddo.moertl@stpoelten.lknoe.at
- Contact Person Name
- Deddo Moertl
- Contact Person Email
- deddo.moertl@stpoelten.lknoe.at
- Site Name
- Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
- Department Name
- Innere Medizin II, Kardiologie, Internistische Intensivmedizin
- Principal Investigator Name
- Michael Lichtenauer
- Principal Investigator Email
- m.lichtenauer@salk.at
- Contact Person Name
- Michael Lichtenauer
- Contact Person Email
- m.lichtenauer@salk.at
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Klinik fuer Kardiologie und Internistische Intensivmedizin; Med Campus III
- Principal Investigator Name
- Clemens Steinwender
- Principal Investigator Email
- clemens.steinwender@kepleruniklinikum.at
- Contact Person Name
- Clemens Steinwender
- Contact Person Email
- clemens.steinwender@kepleruniklinikum.at
Germany
- Earliest CTIS Part Ii Submission Date
- 16-08-2024
- Latest Decision Or Authorization Date
- 27-09-2024
- Processing Time Days
- 42
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Klinik für Kardiologie, Angiologie, Pneumologie (Innere Medizin III)
- Principal Investigator Name
- Philipp Schlegel
- Principal Investigator Email
- philipp.schlegel@med.uni-heidelberg.de
- Contact Person Name
- Philipp Schlegel
- Contact Person Email
- philipp.schlegel@med.uni-heidelberg.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Klinik fuer Kardiologie und Angiologie
- Principal Investigator Name
- Johann Bauersachs
- Principal Investigator Email
- bauersachs.johann@mh-hannover.de
- Contact Person Name
- Johann Bauersachs
- Contact Person Email
- bauersachs.johann@mh-hannover.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik fuer Kardiologie, Angiologie und Intensivmedizin
- Principal Investigator Name
- Frank Edelmann
- Principal Investigator Email
- frank.edelmann@dhzc-charite.de
- Contact Person Name
- Frank Edelmann
- Contact Person Email
- frank.edelmann@dhzc-charite.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Klinik und Poliklinik fuer Innere Medizin I
- Principal Investigator Name
- Christian Kupatt
- Principal Investigator Email
- christian.kupatt@tum.de
- Contact Person Name
- Christian Kupatt
- Contact Person Email
- christian.kupatt@tum.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik fuer Kardiologie, Angiologie und internistische Intensivmedizin
- Principal Investigator Name
- Derk Frank
- Principal Investigator Email
- derk.frank@uksh.de
- Contact Person Name
- Derk Frank
- Contact Person Email
- derk.frank@uksh.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Klinik fuer Kardiologie und Angiologie
- Principal Investigator Name
- Markus Welzel
- Principal Investigator Email
- markus.welzel@uniklinik-freiburg.de
- Contact Person Name
- Markus Welzel
- Contact Person Email
- markus.welzel@uniklinik-freiburg.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 16-09-2024
- Processing Time Days
- 19
- Number Of Sites
- 4
- Number Of Participants
- 25
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Cardiology
- Principal Investigator Name
- Olivier Manintveld
- Principal Investigator Email
- o.manintveld@erasmusmc.nl
- Contact Person Name
- Olivier Manintveld
- Contact Person Email
- o.manintveld@erasmusmc.nl
- Site Name
- Stichting Radboud universitair medisch centrum
- Department Name
- Cardiology
- Principal Investigator Name
- Carlijne Hassing
- Principal Investigator Email
- Carlijne.Hassing@radboudumc.nl
- Contact Person Name
- Carlijne Hassing
- Contact Person Email
- Carlijne.Hassing@radboudumc.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Cardiology
- Principal Investigator Name
- Ahmad Shoaib Amin
- Principal Investigator Email
- a.s.amin@amsterdamumc.nl
- Contact Person Name
- Ahmad Shoaib Amin
- Contact Person Email
- a.s.amin@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- Cardiology
- Principal Investigator Name
- Linda van Laake
- Principal Investigator Email
- researchdhl@umcutrecht.nl
- Contact Person Name
- Linda van Laake
- Contact Person Email
- researchdhl@umcutrecht.nl
Spain
- Earliest CTIS Part Ii Submission Date
- 26-08-2024
- Latest Decision Or Authorization Date
- 10-09-2024
- Processing Time Days
- 15
- Number Of Sites
- 6
- Number Of Participants
- 25
Sites
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Cardiology
- Principal Investigator Name
- Juan Jose Gavira Gomez
- Principal Investigator Email
- jjgavira@unav.es
- Contact Person Name
- Juan Jose Gavira Gomez
- Contact Person Email
- jjgavira@unav.es
- Site Name
- Bellvitge University Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Lidia Alcoberro Torres
- Principal Investigator Email
- lalcoberro@bellvitgehospital.cat
- Contact Person Name
- Lidia Alcoberro Torres
- Contact Person Email
- lalcoberro@bellvitgehospital.cat
- Site Name
- Hospital Universitario La Paz
- Department Name
- Cardiology
- Principal Investigator Name
- Jose Raul Moreno Gomez
- Principal Investigator Email
- joseraul.moreno@salud.madrid.org
- Contact Person Name
- Jose Raul Moreno Gomez
- Contact Person Email
- joseraul.moreno@salud.madrid.org
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Cardiology
- Principal Investigator Name
- Julio Eduardo Nuñez Villota
- Principal Investigator Email
- juenuvi@uv.es
- Contact Person Name
- Julio Eduardo Nuñez Villota
- Contact Person Email
- juenuvi@uv.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Cardiology
- Principal Investigator Name
- Marcelo Sanmartin Fernandez
- Principal Investigator Email
- marcelo.sanmartin@salud.madrid.org
- Contact Person Name
- Marcelo Sanmartin Fernandez
- Contact Person Email
- marcelo.sanmartin@salud.madrid.org
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Cardiology
- Principal Investigator Name
- Jose Ramon Gonzalez Juanatey
- Principal Investigator Email
- Jose.Ramon.Gonzalez.Juanatey@sergas.es
- Contact Person Name
- Jose Ramon Gonzalez Juanatey
- Contact Person Email
- Jose.Ramon.Gonzalez.Juanatey@sergas.es
Belgium
- Earliest CTIS Part Ii Submission Date
- 16-07-2025
- Latest Decision Or Authorization Date
- 08-08-2025
- Processing Time Days
- 23
- Number Of Sites
- 4
- Number Of Participants
- 25
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Cardiology
- Principal Investigator Name
- Frank Timmermans
- Principal Investigator Email
- cardiologie@uzgent.be
- Contact Person Name
- Frank Timmermans
- Contact Person Email
- cardiologie@uzgent.be
- Site Name
- Onze-Lieve-Vrouwziekenhuis
- Department Name
- Cardiology
- Principal Investigator Name
- Marc Vanderheyden
- Principal Investigator Email
- cardio.studie.aalst@azorg.be
- Contact Person Name
- Marc Vanderheyden
- Contact Person Email
- cardio.studie.aalst@azorg.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Cardiology
- Principal Investigator Name
- Karl Dujardin
- Principal Investigator Email
- ctc.cardio@azdelta.be
- Contact Person Name
- Karl Dujardin
- Contact Person Email
- ctc.cardio@azdelta.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Cardiology
- Principal Investigator Name
- Emeline Van Craenenbroeck
- Principal Investigator Email
- Studies.cardiologie@uza.be
- Contact Person Name
- Emeline Van Craenenbroeck
- Contact Person Email
- Studies.cardiologie@uza.be
Sponsor
Primary sponsor
- Full Name
- Askbio Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Third parties
- {"country":"Germany","full_name":"Bayer AG","duties_or_roles":"sponsorDuties codes: [1,10,11,13,2,3,4,5,6,7,8]; contact: clinical-trials-contact@bayer.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- AB-1002
- Active Substance
- AB-1002
- Modality
- Gene therapy
- Routes Of Administration
- INTRACORONARY USE
- Route
- Intracoronary
- Authorisation Status
- prodAuthStatus: 1
- Frequency
- Single antegrade intracoronary infusion
- Maximum Dose
- 143000000000000.00 (doseUom: Other, maxDailyDoseAmount/maxTotalDoseAmount provided in record)
- Investigational Product Name
- AB-1002 Placebo
- Modality
- Other
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