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Avalglucosidase Alfa French Post-trial Access for Participants With Pompe Disease (PTA Avalglucosidase)

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Sep 30, 2026 → Jun 30, 2027
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Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 30, 2026 to Jun 30, 2027
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study description expanded, about 12 words
    v16
  2. Primary and study completion dates: Dec 31, 2025 to Sep 30, 2026
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study description revised
    v15
  3. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025
    • Study sites: 10 to 11
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study description revised
    v14
  4. Re-verified, no change to tracked fieldsv13
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 18 to confirmed 17
    • Primary and study completion dates: Jan 5, 2025 to Dec 31, 2024
    • Site details revised at 10 of 10 sites
    v12
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  1. Primary and study completion dates: Dec 2024 to Jan 5, 2025v11
  2. Re-verified, no change to tracked fieldsv10
  3. Primary and study completion dates: May 31, 2023 to Dec 2024
    • Eligibility criteria expanded, about 59 words
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study description expanded, about 17 words
    v9
  4. Re-verified, no change to tracked fieldsv8
  5. Start date: Jul 1, 2022 to Jul 11, 2022v7
  6. Re-verified, no change to tracked fieldsv6
  7. Start date changed from estimate of Jul 24, 2022 to Jul 1, 2022v5
  8. Study sites: 1 to 10
    • Start date: Jul 4, 2022 to Jul 24, 2022
    v4
  9. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  10. Start date: Feb 15, 2022 to Jul 4, 2022
    • Secondary endpoints revised (9)
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sanofi
284 trials monitored
See 12 trials at risk
This long-term open label safety and efficacy study is intended to follow up, and to provide post-trial access to ERT with avalglucosidase alfa to patients with Pompe disease in France who have completed Study EFC14028, LTS13769, or ACT14132, from market authorization until the conclusion of negotiations of avalglucosidase alfa in France under the standard reimbursement framework on each indication independently, infantile (IOPD) and late (LOPD), or until June 2027, whichever comes first. \- Study visit frequency: every 2 weeks
Trial Details
NCT Number NCT05164055
Lead Sponsor Genzyme, a Sanofi Company
Conditions
(from sponsor)		 Glycogen Storage Disease Type II
Related terms Glycogen Storage Disease Type II
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov