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

Status: Recruiting
Location: See all (46) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subject must be age ≥18 years of age, at the time of signing the informed consent.

• Chronic non-ischemic cardiomyopathy

• 15% ≤ LVEF ≤ 35% by transthoracic echocardiography (TTE) at screening

• 6MWT \>50 meters

• Medically stable, NYHA Class III HF for a minimum of 4 weeks while on appropriate medical therapy (defined below) including, but not limited to:

∙ 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

‣ 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.

• 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

• 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

• Appropriate candidate for protocol-specified intracoronary infusion in the judgment of the infusing interventional cardiologist

Locations
United States
Alabama
Cardiology P.C. Birmingham
NOT_YET_RECRUITING
Birmingham
California
University of California San Diego
RECRUITING
La Jolla
Florida
Baycare Medical Group
RECRUITING
Clearwater
University of Miami
RECRUITING
Coral Gables
University of Florida
RECRUITING
Gainesville
Georgia
Augusta University
RECRUITING
Augusta
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
Illinois
Loyola Medicine Burr Ridge
RECRUITING
Oakbrook Terrace
Kansas
University of Kansas Medical Center (KUMC)
RECRUITING
Kansas City
Minnesota
Minneapolis Heart Institute Foundation
RECRUITING
Minneapolis
Mayo Clinic - Minnesota
RECRUITING
Rochester
Missouri
St. Louis University
RECRUITING
St Louis
North Carolina
Sanger Heart and Vascular Institute
NOT_YET_RECRUITING
Charlotte
Nevada
Renown Health
RECRUITING
Reno
New York
Mt. Sinai New York
NOT_YET_RECRUITING
New York
Stony Brook
RECRUITING
Stony Brook
Ohio
The Christ Hospital / The Linder Center for Research
RECRUITING
Cincinnati
University of Cincinnati
RECRUITING
Cincinnati
The Ohio State University
RECRUITING
Columbus
Pennsylvania
LVH Cardiology
RECRUITING
Allentown
South Carolina
Medical University of South Carolina (MUSC) Medical Center
RECRUITING
Charleston
Tennessee
Stern Cardiovascular
RECRUITING
Germantown
Texas
Baylor Scott & White Advanced Heart Failure Clinic - Dallas
RECRUITING
Dallas
Baylor College of Medicine (BCM) - Baylor Heart Clinic
RECRUITING
Houston
Houston Methodist Debakey Cardiology Associates
NOT_YET_RECRUITING
Houston
Washington
University of Washington
RECRUITING
Seattle
Wisconsin
University of Wisconsin
NOT_YET_RECRUITING
Madison
Other Locations
Austria
Medizinische Universität Graz
RECRUITING
Graz
Kardiologie & Intensivmedizin Campus III
RECRUITING
Linz
SALK University Hospital
ACTIVE_NOT_RECRUITING
Salzburg
NÖ Landesgesundheitsagentur
RECRUITING
Sankt Pölten
Germany
Charité Universitaetsmedizin
RECRUITING
Berlin
Medizinische Hochschule Hannover (MHH)
RECRUITING
Hanover
Universitätsklinikum Schleswig-Holstein
RECRUITING
Kiel
Netherlands
Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
RECRUITING
Amsterdam
Radboud University Medical Center
RECRUITING
Nijmegen
Erasmus Medisch Centrum
ACTIVE_NOT_RECRUITING
Rotterdam
Universitair Medisch Centrum (UMC) Utrecht
RECRUITING
Utrecht
Spain
Hospital Universitario de Bellvitge
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Ramon y Cajal | Cardiology - Research Unit
ACTIVE_NOT_RECRUITING
Madrid
Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz (HULP)
RECRUITING
Madrid
Universidad de Navarra - Clinica Universidad de Navarra (CUN)
ACTIVE_NOT_RECRUITING
Pamplona
Complejo Hospitalario Universitario Santiago de Compostela (CHUS)
ACTIVE_NOT_RECRUITING
Santiago De Compostela
Hospital Clinico Universitario de Valencia (CHUV)
RECRUITING
Valencia
United Kingdom
Imperial College London - National Heart & Lung Institute (NHLI) - Royal Brompton Campus
ACTIVE_NOT_RECRUITING
London
Manchester Royal Infirmary
ACTIVE_NOT_RECRUITING
Manchester
Contact Information
Primary
Medical Affairs
AskFirst@askbio.com
(919) 561-6210
Time Frame
Start Date: 2023-10-20
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 150
Treatments
Experimental: AB-1002
Randomized in 1:1:1 into one of three groups.~Group 1: 3.25E13vg (n=30-50)
Experimental: Treatment Group 2 AB-1002
Randomized in 1:1:1 into one of three groups.~Group 2: 6.5E13vg (n=30-50)
Placebo_comparator: Treatment Group 3
Randomized in 1:1:1 into one of three groups.~Group 3: Placebo (n=30-50)
Related Therapeutic Areas
Sponsors
Leads: AskBio Inc

This content was sourced from clinicaltrials.gov