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Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure
Sponsor: AskBio Inc
Summary
This is a Phase 2 adaptive, double-blinded, placebo-controlled, randomized, multi-center trial study to evaluate the safety and efficacy of a single dose of AB-1002, administered via antegrade intracoronary artery infusion, in males and females age \>18 years with non-ischemic cardiomyopathy and NYHA Class III symptoms of HF. Subjects will be randomized into one of three treatment groups in a 1:1:1
Official title: A Phase 2, Adaptive, Double-blinded, Placebo Controlled, Randomized, Multi-center Trial to Evaluate the Efficacy, Safety and Tolerability of Intracoronary Infusion of AB-1002 in Adult Subjects With New York Heart Association (NYHA) Class III Heart Failure and Non-ischemic Cardiomyopathy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2023-10-20
Completion Date
2030-12-31
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
AB-1002
Intracoronary Infusion of AB-1002 or placebo
Locations (96)
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