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A Gene Transfer Study for Late-Onset Pompe Disease (RESOLUTE)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv15
  2. Primary completion date: Oct 2023 to Apr 2032
    • Enrollment target: estimated 30 to confirmed 4
    • Study completion date: Oct 2027 to Apr 2032
    v14
  3. Re-verified, no change to tracked fieldsv13
  4. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 20 to 29
    v12
  5. Site contacts updated at 1 of 20 sitesv11
Show 9 earlier versionsHide 9 earlier versions
  1. Site contacts updated at 1 of 20 sitesv10
  2. Enrollment target: 20 to 30
    • Study completion date: Oct 2023 to Oct 2027
    • Site details revised at 3 of 20 sites
    v9
  3. Site details revised at 2 of 20 sitesv8
  4. Study sites: 18 to 20v7
  5. Primary and study completion dates: Aug 2023 to Oct 2023
    • Start date changed from estimate of Aug 2020 to Oct 1, 2020
    v6
  6. Trial status: Suspended to Recruiting
    • Start date: May 2020 to Aug 2020
    • Study sites: 1 to 18
    • Primary and study completion dates: May 2023 to Aug 2023
    v5
  7. Trial status: Recruiting to Suspended Sponsor's reason: Due to the COVID-19 pandemic, enrollment has been suspended until further notice
    • Start date: Mar 2020 to May 2020
    • Primary and study completion dates: Mar 2023 to May 2023
    • Site details revised
    v4
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Dec 2019 to Mar 2020
    • Study sites: 0 to 1
    • Primary and study completion dates: Dec 2022 to Mar 2023
    v3
  9. Study title expanded, about 1 wordv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of a single intravenous infusion of SPK-3006 in adults with clinically moderate, late-onset Pompe disease receiving enzyme replacement therapy (ERT). Participants will be treated in sequential, dose-level cohorts.
Trial Details
NCT Number NCT04093349
Lead Sponsor Spark Therapeutics, Inc.
Conditions
(from sponsor)		 Pompe Disease, Pompe Disease (Late-onset), Glycogen Storage Disease Type 2, Glycogen Storage Disease Type II, LOPD, Lysosomal Storage Diseases, Acid Maltase Deficiency
Related terms Glycogen Storage Disease Type II, Lysosomal Storage Diseases
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov