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A Study of mRNA-3745 in Adult and Pediatric Participants With Glycogen Storage Disease Type 1a (GSD1a)

StatusActive, Not Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Notable Primary completion date: May 26, 2026 to Nov 30, 2026v20 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 45 to confirmed 15
    • Study completion date: Dec 26, 2028 to Nov 30, 2026
    • Site details revised at 16 of 16 sites
  2. Minor Re-verified, no change to tracked fieldsv19
  3. Minor Study sites: 10 to 16v18
  4. Minor Primary completion date: Jan 7, 2026 to May 26, 2026
    • Eligibility criteria shortened, about 16 words
    v17
  5. Minor Study sites: 9 to 10v16
Show 14 earlier versionsHide 14 earlier versions
  1. Minor Study sites: 8 to 9v15
  2. Notable Phase: Phase 1 to Phase 1/2v14 Show 7 more changesShow less
    • Primary completion date: Oct 21, 2024 to Jan 7, 2026
    • Primary endpoint revised
    • Enrollment target: 33 to 45
    • Study completion date: Oct 21, 2025 to Dec 26, 2028
    • Eligibility criteria shortened, about 46 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 1 word
  3. Minor Study sites: 6 to 8v13
  4. Notable Enrollment target: 18 to 33v12 Show 8 more changesShow less
    • Primary completion date: Jan 19, 2024 to Oct 21, 2024
    • Study sites: 7 to 6
    • Study completion date: Jan 19, 2024 to Oct 21, 2025
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: 15 to 8
    • Study description expanded, about 10 words
    • Study arms: 1 to 2
    • Study title expanded, about 3 words
  5. Minor Study sites: 6 to 7v11
  6. Minor Study description shortened, about 4 wordsv10
  7. Minor Study sites: 5 to 6
    • Eligibility criteria revised
    • Secondary endpoints: 11 to 15
    v9
  8. Minor Start date changed from estimate of May 10, 2022 to Jun 1, 2022v8
  9. Notable Start date: Mar 21, 2022 to May 10, 2022
    • Study sites: 3 to 5
    v7
  10. Minor Study sites: 2 to 3v6
  11. Notable Start date: Jan 28, 2022 to Mar 21, 2022
    • Study sites: 1 to 2
    v5
  12. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 17, 2022 to Jan 28, 2022
    • Site details revised
    v4
  13. Minor Site contact updatedv3
  14. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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.
49 trials monitored
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The main goal of this trial is to evaluate the safety and tolerability of mRNA-3745 via intravenous (IV) administration in adult and pediatric participants with GSD1a.
Trial Details
NCT Number NCT05095727
Lead Sponsor ModernaTX, Inc.
Conditions
(from sponsor)
Glycogen Storage Disease
Related terms Genetic Diseases, Inborn, Glucose Metabolism Disorders, Glycogen Storage Disease, Glycogen Storage Disease Type I
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov