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Heart Disease, Ischemic / Heart Failure / Congestive Heart Failure · Phase 1 Trial
ClinicalTrials.gov · August 6, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registration for AB-1002, a gene therapy candidate, in patients with NYHA Class III heart failure. The study is completed but no results are posted in this registry record; it was designed as an open-label, single-arm dose escalation study to assess safety and feasibility over 12 months with extended follow-up to 36 months.
Phase 1, Interventional, Non Randomized, Sequential, Open label, Treatment purpose. Congestive Heart Failure, Heart Failure, Heart Disease, Ischemic, Cardiovascular Diseases, Heart Failure, Systolic, Heart Failure，Congestive, Heart Arrhythmia,…; age from 18 Years. Intervention: 3.25E13vg AB-1002; 1.08E14vg AB-1002; PLN-R14Del patients: 3.25E13vg AB-1002. n = 11. 4 sites: United States.
This is a Phase 1 trial registration for AB-1002, a gene therapy candidate, in patients with NYHA Class III heart failure. The study is completed but no results are posted in this registry record; it was designed as an open-label, single-arm dose escalation study to assess safety and feasibility over 12 months with extended follow-up to 36 months.
No results posted in this registry record; outcomes and safety data not reported. Small sample size (n=11) is appropriate for Phase 1 safety but insufficient for efficacy claims.
No clinical impact can be assessed; this registry record reports no outcomes. Results must be published separately to evaluate safety, feasibility, or any signal of efficacy.
Phase 1 open-label dose escalation study with no results posted; designed to explore safety and feasibility in a small uncontrolled cohort.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed; this registry record reports no outcomes. Results must be published separately to evaluate safety, feasibility, or any signal of efficacy.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04179643). This is a study registration, not published results. Lead sponsor: AskBio Inc. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 11 participants (ACTUAL). Conditions: Congestive Heart Failure, Heart Failure, Heart Disease, Ischemic, Cardiovascular Diseases, Heart Failure, Systolic, Heart Failure，Congestive, Heart Arrhythmia, Heart Failure, Diastolic, Heart; Complications. Interventions: BIOLOGICAL: 3 x 10e13vg AB-1002. Primary outcome measures: Observed and change from baseline in Peak VO2 , Measured at screening, month 6, 9 and month 12; Observed and change from baseline in Echocardiographic assessment in Left Ventricular Ejection Fraction , Measured at screening, 18-24 hours post intervention, week 4, Month 3, Month 6 and Month 12. Brief summary: This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of AB-1002 in patients with NYHA Class III heart failure. 11 participants with non-ischemic cardiomyopathy were enrolled. All participants were followed until 12 months post treatment intervention, and then underwent long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.