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ACTIVE NOT RECRUITING
NCT05598333
PHASE2

Phosphatase Inhibition by Intracoronary Gene Therapy in Subjects With Non-Ischemic NYHA Class III Heart Failure

Sponsor: AskBio Inc

View on ClinicalTrials.gov

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

Interventions

DRUG

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