Clinical Trial

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

Study acronym: GenePHIT
Active, Not Recruiting Phase 2
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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
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2022-10-25; most recent amendment 2025-11-26.
Status change: Recruiting → Active, Not Recruiting 2025-11-26
Status change: Active, Not Recruiting → Recruiting 2023-12-19
Status change: Not Yet Recruiting → Active, Not Recruiting 2023-09-26
Trial Details
NCT Number NCT05598333
Lead Sponsor AskBio Inc
Conditions Congestive Heart Failure
Enrollment 150 participants
Start Date 2023-10-20
Primary Completion 2026-10-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-12-03