Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure
NCT ID: NCT05598333
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2023-10-20
2030-12-31
Brief Summary
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Subjects will be randomized into one of three treatment groups in a 1:1:1
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Detailed Description
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Approximately 90 to 150 subjects will be randomly assigned to study intervention Placebo
Study duration until the primary analysis at 52 week will be approximately 37 months including 25 months of recruitment and 52-week Observation Period after dosing. Once all the subjects complete the 52 weeks Observation Period, the treatment groups will be unblinded and primary analysis performed. Study participation duration: The study will last 52 weeks from dosing, with another 4 years of long-term follow-up for a total of 5 years. During the 4 year long-term follow up sites will contact subjects twice a year for two years, then once a year for the remaining two years for safety, efficacy assessments, and survival
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment Group 1 AB-1002
Randomized in 1:1:1 into one of three groups. Group 1: 7.15E13vg/subject (n=30-50)
AB-1002
Intracoronary Infusion of AB-1002 or placebo
Treatment Group 2 AB-1002
Randomized in 1:1:1 into one of three groups.
Group 2: 1.43E14vg/subject (n=30-50)
AB-1002
Intracoronary Infusion of AB-1002 or placebo
Treatment Group 3
Randomized in 1:1:1 into one of three groups.
Group 3: Placebo (n=30-50)
AB-1002
Intracoronary Infusion of AB-1002 or placebo
Interventions
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AB-1002
Intracoronary Infusion of AB-1002 or placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Chronic non-ischemic cardiomyopathy
3. 15% ≤ LVEF ≤ 35% by transthoracic echocardiography (TTE) at screening
4. 6MWT \>50 meters
5. Medically stable, NYHA Class III HF for a minimum of 4 weeks while on appropriate medical therapy (defined below) including, but not limited to:
1. Beta blocker therapy and ACE inhibitor or angiotensin receptor blocker (ARB) or sacubitril/valsartan combination therapy (Entresto) for ≥ 90 days prior to enrollment.
May also receive aldosterone antagonist therapy. Doses of the above medications must be stable for ≥ 30 days prior to enrollment; and
2. Cardiac resynchronization therapy (Zareba et al 2011), if clinically indicated, must have been implanted ≥ 90 days prior to enrollment. Internal cardioverter defibrillator (ICD) must be implanted, if clinically indicated ≥ 30 days prior to enrollment.
6. Women of childbearing potential must use at least one of the following acceptable birth control methods throughout the study and for 6 months after IP administration:
* Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum prior to IP administration
* Intrauterine device in place for at least 90 days prior to receiving IP
* Barrier methods (diaphragm plus spermicide or condom) starting at least 30 days prior to receiving IP
* Abstinence (the subject must be willing to remain abstinent from screening to 6 months after receiving IP). 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 IP administration
* Hormonal contraceptives starting \> 90 days prior to IP. If hormonal contraceptives are started less than 90 days prior to receiving IP, subjects must agree to use a barrier method (diaphragm plus spermicide or condom) from screening through 90 days after initiation of hormonal contraceptives
7. Males subjects capable of fathering a child:
* Must agree to use a condom and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant from IP administration through 6 months after the time of IP administration
* Must agree not to donate sperm for 6 months after time of receiving IP
* Documented evidence of vasectomy in males for 180 days minimum prior to receiving IP 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 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
8. Appropriate candidate for protocol-specified intracoronary infusion in the judgment of the infusing interventional cardiologist
Exclusion Criteria
9. Chronic ischemic cardiomyopathy secondary to obstructive coronary artery disease
10. Intravenous (IV) inotropic therapy, intra-aortic balloon pump (IABP) or percutaneous cardiac assist device therapy within 30 days prior to enrollment
11. Restrictive cardiomyopathy, obstructive cardiomyopathy, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease, or dyskinetic LV aneurysm
12. Cardiac surgery or percutaneous coronary intervention (PCI) within 30 days prior to screening
13. Uncorrected Third degree heart block
14. Clinically significant myocardial infarction (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
15. Prior heart transplantation, left ventricular reduction surgery (LVRS), cardiomyoplasty, passive restraint device (e.g., CorCap™ Cardiac Support Device), surgically implanted LVAD or cardiac shunt
16. Likely to receive cardiac resynchronization therapy, cardiomyoplasty, LV reduction surgery, heart transplant, conventional revascularization procedure, or valvular repair within 3 months of IP dosing in judgement of investigator.
17. 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.
18. Expected survival \< 1 year in the judgment of the investigator
19. Active or suspected infection within 48 hours prior to intra-coronary infusion as evidenced by fever or positive culture
20. Known intrinsic liver disease (e.g., cirrhosis, hepatitis A, chronic hepatitis B or hepatitis C virus infection). If serology is positive and PCR is known to be negative, subject may be eligible (confirm with medical monitor).
21. Liver function tests (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], alkaline phosphatase) \> 2x upper limit of normal (ULN) within 30 days prior to enrollment.
22. Chronic Kidney Disease Stage 5, dialysis dependent or eGFR\<15 within 30 days prior to enrollment
23. Bleeding diathesis or thrombocytopenia defined as platelets \<50,000 platelets/μL within 30 days prior to enrollment
24. Anemia defined as hemoglobin \<10 g/dL or transfusion dependent within 30 days prior to enrollment
25. Neutropenia defined as absolute neutrophils \<1500 mm3 within 30 days prior to enrollment
26. Known AIDS or HIV-positive status, or a previous diagnosis of immunodeficiency with an absolute neutrophil count \<1000 cells/mm3
27. Previous participation in a study of gene transfer
28. 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.
29. Pregnancy or breastfeeding or plans to become pregnant within the next 12 months at the time of screening
30. Subjects with any other condition which in the opinion of the investigator would preclude participation in the study (including risk for non-compliance and any intercurrent conditions that pose an undue medical hazard, or which could interfere with the interpretation of the study results)
31. 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)
32. Any documented history of non-compliance with medications, illicit drug use or laboratory evidence of illicit drug use during screen period
18 Years
ALL
No
Sponsors
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AskBio Inc
INDUSTRY
Responsible Party
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Locations
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Cardiology P.C. Birmingham
Birmingham, Alabama, United States
University of Arizona Sarvor Heart Center
Tucson, Arizona, United States
University of California Irvine Medical Center
Irvine, California, United States
University of California San Diego
La Jolla, California, United States
University of California San Francisco
San Francisco, California, United States
Baycare Medical Group
Clearwater, Florida, United States
University of Miami
Coral Gables, Florida, United States
University of Florida
Gainesville, Florida, United States
Augusta University
Augusta, Georgia, United States
Loyola Medicine Burr Ridge
Oakbrook Terrace, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic - Minnesota
Rochester, Minnesota, United States
Aurora Saint Luke's Health System
Kansas City, Missouri, United States
St. Louis University
St Louis, Missouri, United States
Renown Health
Reno, Nevada, United States
Morristown Medical Center - Cardiology
Morristown, New Jersey, United States
Mt. Sinai New York
New York, New York, United States
Stony Brook
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University
Durham, North Carolina, United States
The Christ Hospital / The Linder Center for Research
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
LVH Cardiology
Allentown, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC) Medical Center
Charleston, South Carolina, United States
Stern Cardiovascular
Germantown, Tennessee, United States
Baylor Scott & White Advanced Heart Failure Clinic - Dallas
Dallas, Texas, United States
Baylor College of Medicine (BCM) - Baylor Heart Clinic
Houston, Texas, United States
Houston Methodist Debakey Cardiology Associates
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Medizinische Universität Graz
Graz, , Austria
Kardiologie & Intensivmedizin Campus III
Linz, , Austria
SALK University Hospital
Salzburg, , Austria
NÖ Landesgesundheitsagentur
Sankt Pölten, , Austria
UZ Antwerpen
Edegem, , Belgium
Multiprofile Hospital for Active Treatment Sveti Georgi OOD
Pernik, , Bulgaria
Specialized Hospital For Active Cardiology Treatment Medica Kor EAD
Rousse, , Bulgaria
Multiprofile Hospital for Active Treatment "South West Hospital" OOD
Sandanski, , Bulgaria
Multiprofile Hospital for Active Treatment 'National Cardiology Hospital' EAD
Sofia, , Bulgaria
Acibadem City Clinic University Multiprofile Hospital For Active Treatment Tokuda EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment 'Sveta Ekaterina' EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov EAD
Sofia, , Bulgaria
University Multiprofile Hospital For Active Treatment Sofiamed OOD
Sofia, , Bulgaria
St. Boniface Hospital
Winnipeg, Manitoba, Canada
Memorial University Hospital
St. John's, Newfoundland and Labrador, Canada
London Health Sciences Centre
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
CIUSSS Saguenay Lac-St-Jean
Chicoutimi, Quebec, Canada
Institut de Cardiologie de Montréal
Montreal, Quebec, Canada
Centre Hospitalier de l'Université de Montréal - CHUM
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Québec - Université Laval
Québec, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec - IUCPQ
Québec, Quebec, Canada
Technical University of Munich (TUM)
München, Bavaria, Germany
Charité Universitaetsmedizin
Berlin, , Germany
Universitaetsklinikum Freiburg | Herz-Zentrum Bad Krozingen (Heart Centre Bad Krozingen)
Freiburg im Breisgau, , Germany
Medizinische Hochschule Hannover (MHH)
Hanover, , Germany
Heidelberg University Hospital
Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati Klinika
Budapest, , Hungary
Észak-Pesti Centrumkórház - Honvédkórház
Budapest, , Hungary
Budapesti Uzsoki Utcai Korhaz
Budapest, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz - Kardiologiai Osztaly
Kaposvár, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont, Szivgyogyaszati Klinika
Pécs, , Hungary
Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ - Belgyógyászati Klinika
Szeged, , Hungary
Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
Amsterdam, North Holland, Netherlands
Radboud University Medical Center
Nijmegen, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Universitair Medisch Centrum (UMC) Utrecht
Utrecht, , Netherlands
American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie
Chrzanów, , Poland
1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ w Lublinie
Lublin, , Poland
Uniwersytecki Szpital Kliniczny (USK) Nr 4 w Lublinie
Lublin, , Poland
Spitalul Clinic Judetean De Urgenta Targu Mures
Târgu Mureş, County Mures, Romania
Spitalul Clinic Judetean De Urgenta Brasov- Sectia Cardiologie 3
Brasov, , Romania
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila", Sectia Clinica Cardiologie I
Bucharest, , Romania
Spitalul Clinic Judetean De Urgenta Craiova- Sectia de Cardiologie
Craiova, , Romania
Spitalul Universitar de Urgenta Bucuresti- Sectia Cardiologie 2
Târgu Mureş, , Romania
Institutul De Boli Cardiovasculare Timisoara- Clinica de Cardiologie
Timișoara, , Romania
Hospital Universitario de Bellvitge
Barcelona, Catalonia, Spain
Universidad de Navarra - Clinica Universidad de Navarra (CUN)
Pamplona, Navarre, Spain
Hospital Ramon y Cajal | Cardiology - Research Unit
Madrid, , Spain
Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP)
Madrid, , Spain
Complejo Hospitalario Universitario Santiago de Compostela (CHUS)
Santiago de Compostela, , Spain
Hospital Clinico Universitario de Valencia (CHUV)
Valencia, , Spain
Manchester Royal Infirmary
Manchester, Manchester, United Kingdom
Leeds General Infirmary
Leeds, West Yorkshire, United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
NHS Golden Jubilee
Glasgow, , United Kingdom
Imperial College London - National Heart & Lung Institute (NHLI) - Royal Brompton Campus
London, , United Kingdom
Countries
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Other Identifiers
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ASK-CHF2-CS201
Identifier Type: -
Identifier Source: org_study_id
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