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

Study acronym: GenePHIT
StatusActive, Not Recruiting
PhasePhase 2
SponsorAskBio Inc
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Study sites: 101 to 96v14 Show 1 more changeShow less
    • Study sites: 101 to 96
  2. Primary endpoints: 5 to 4 Study sites: 46 to 101v13 Show 1 more changeShow less
    • Study sites: 46 to 101

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 45 to 46v12
  4. Study sites: 43 to 45 Study description revisedv11 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 40 to 43v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 28 to 40v9
  2. Study sites: 9 to 28v8
  3. Primary completion date: Dec 2030 to Oct 31, 2026 Study sites: 3 to 9 · Completion date: Dec 2030 to Dec 31, 2030v7 Show 2 more changesShow less
    • Study sites: 3 to 9
    • Completion date: Dec 2030 to Dec 31, 2030
  4. Primary and study completion dates: Dec 2029 to Dec 2030v6
  5. Study sites: 1 to 3v5
  6. Trial status: Active, Not Recruiting to Recruiting Start date: Sep 15, 2023 to Oct 20, 2023 · Site details revisedv4 Show 2 more changesShow less
    • Start date: Sep 15, 2023 to Oct 20, 2023
    • Site details revised
  7. Start date changed from estimate of Apr 2023 to Sep 15, 2023 Trial status: Not Yet Recruiting to Active, Not Recruiting · Study sites: 0 to 1 · Interventions: NAN-101 (Drug) to AB-1002 (Drug) · 1 morev3 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Interventions: NAN-101 (Drug) to AB-1002 (Drug)
    • Eligibility criteria shortened, about 16 words

    See this version in full on ClinicalTrials.gov ↗

  8. Start date: Dec 2022 to Apr 2023 Study title shortened, about 23 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 23 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
AskBio Inc
9 trials monitored
See 3 trials at risk
Heart Failure
1,871 trials monitored
See 100 trials at risk
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
Trial Details
NCT Number NCT05598333
Lead Sponsor AskBio Inc
Conditions Congestive Heart Failure
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov