ASK-CHF2-CS201 - GENEPHIT
Research type
Research Study
Full title
A Phase 2, adaptive, double-blinded, placebo-controlled, randomized, multi-centre 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.
IRAS ID
1009799
Contact name
Claire Tran
Contact email
Sponsor organisation
AskBio Inc.
Eudract number
2024-510581-17
Clinicaltrials.gov Identifier
Research summary
The GenePHIT study aims to evaluate the effectiveness and safety of a new gene therapy, AB-1002, in individuals with congestive heart failure (CHF). CHF is a condition in which the heart is unable to pump blood efficiently and to meet the demands of the body, leading to symptoms like breathlessness and fatigue. With limited treatment options for severe cases, this study explores AB-1002 as a potential treatment for CHF.
The study's primary objective is to assess how participants respond to 2 different dose levels of AB-1002 compared to a placebo over 52 weeks. Researchers will measure factors such as heart failure-related deaths, heart function, and participants' ability to perform physical activities. Additionally, the study will evaluate the safety of AB-1002 in CHF patients, monitoring any medical issues that arise after treatment.
Participants will receive AB-1002 or a placebo through a single infusion into the heart's main arteries. Various tests and procedures, including imaging and regular health check-ups, will be conducted throughout the study period. The study will span over five years, including a screening period, a treatment period of one year, and long-term follow-up.
Eligible participants must be at least 18 years old, diagnosed with heart failure, and meet specific health criteria. Those with certain heart conditions or recent heart surgeries may not qualify. Potential benefits include the possibility of a new treatment option for CHF, while risks include the uncertainty of AB-1002's effects and potential side effects.
The study's findings may provide valuable insights into the potential of AB-1002 as a treatment for CHF and determine the need for further research in this area.REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0365
Date of REC Opinion
9 Jul 2024
REC opinion
Further Information Favourable Opinion