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ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Jun 2026 → Mar 2027
See other at-risk trials from Amicus Therapeutics

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jun 2026 to Mar 2027
    • Study completion pushed from Jun 2026 to Sep 2027
    • Eligibility criteria expanded, about 17 words
    • Site details revised at 6 of 17 sites
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 22 to confirmed 21
    • Study sites: 23 to 17
    v17
  3. 2 versions Re-verified since Sep 16, 2024, no change to tracked fieldsv15-v16
  4. Study sites: 18 to 23v14
  5. Site details revised at 4 of 18 sitesv13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 15 to 18v12
  2. Study sites: 14 to 15v11
  3. Study sites: 13 to 14
    • Study title shortened, about 7 words
    • Eligibility criteria shortened, about 3 words
    v10
  4. Primary and study completion dates: Sep 2021 to Jun 2026v9
  5. Enrollment target: 14 to 22
    • Eligibility criteria expanded, about 86 words
    v8
  6. Primary endpoints: 2 to 1v7 Show 6 more changesShow less
    • Study sites: 10 to 13
    • Interventions: AT2221 (Drug), ATB200 (Biological) to Cipaglucosidase Alfa (Biological), Miglustat (Drug)
    • Eligibility criteria expanded, about 147 words
    • Secondary endpoints: 15 to 1
    • Study description shortened, about 188 words
    • Study title expanded, about 5 words
  7. Study sites: 9 to 10
    • Secondary endpoints: 16 to 15
    v6
  8. Primary completion date: Feb 2021 to Sep 2021
    • Study sites: 8 to 9
    • Study completion date: Jun 2021 to Sep 2021
    • Start date changed from estimate of Feb 2020 to Feb 13, 2020
    v5
  9. Start date: Dec 2019 to Feb 2020
    • Study sites: 7 to 8
    v4
  10. Start date: Aug 2019 to Dec 2019v3 Show 5 more changesShow less
    • Study sites: 3 to 7
    • Eligibility criteria shortened, about 144 words
    • Secondary endpoints revised (16)
    • Study description shortened, about 141 words
    • Study title expanded, about 3 words
  11. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date: Jul 2019 to Aug 2019
    v2
  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.
This is a Phase 3, open-label, multicenter study to evaluate the safety, PK, efficacy, PD, and immunogenicity of Cipaglucosidase Alfa/Miglustat treatment in enzyme replacement therapy (ERT)-experienced and ERT-naïve pediatric subjects with Pompe disease, aged 0 to \< 18 years
Trial Details
NCT Number NCT03911505
Lead Sponsor Amicus Therapeutics
Conditions
(from sponsor)		 Pompe Disease (Late-onset)
Related terms Glycogen Storage Disease Type II
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov