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Evaluating the Efficacy and Safety of D-galactose in PGM1-CDG (AVTX-801)

Study acronym: AVTX-801
StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Start date: Feb 2, 2026 to Oct 1, 2026v11
  2. Primary and study completion dates: Dec 2025 to Mar 2, 2028
    • Start date: Sep 2025 to Feb 2, 2026
    v10
  3. Start date: Mar 2025 to Sep 2025v9
  4. Start date: Dec 2024 to Mar 2025v8
  5. Primary and study completion dates: Mar 2025 to Dec 2025v7 Show 8 more changesShow less
    • Start date: Feb 2024 to Dec 2024
    • Primary endpoint revised
    • Enrollment target: 9 to 8
    • Interventions: AVTX-801 (Drug) to AVTX-801 (Drug), Placebo (Drug)
    • Study description expanded, about 32 words
    • Study title revised
    • Study arms: 1 to 2
    • Collaborators expanded, about 4 words
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Nov 2023 to Feb 2024
    • Primary and study completion dates: Nov 2024 to Mar 2025
    v6
  2. Phase: Phase 1 to Phase 2v5 Show 4 more changesShow less
    • Start date: Jun 2023 to Nov 2023
    • Study sites: 0 to 1
    • Primary and study completion dates: Jun 2024 to Nov 2024
    • Eligibility criteria expanded, about 30 words
  3. Re-verified, no change to tracked fieldsv4
  4. Start date: Oct 8, 2022 to Jun 2023
    • Primary completion date: Jun 30, 2024 to Jun 2024
    • Study completion date: Sep 30, 2024 to Jun 2024
    v3
  5. Phase: Phase 2/3 to Phase 1v2 Show 5 more changesShow less
    • Primary completion date: Sep 30, 2024 to Jun 30, 2024
    • Study completion date: Dec 31, 2024 to Sep 30, 2024
    • Start date: Oct 1, 2022 to Oct 8, 2022
    • Study title shortened, about 8 words
    • Study arms: 2 to 1
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial to evaluate the efficacy of AVTX-801 (D-galactose) on the clinical manifestations of PGM1-CDG in participants currently taking D-galactose.
Trial Details
NCT Number NCT05402332
Lead Sponsor Eva Morava-Kozicz
Collaborators: Children's Hospital of Philadelphia
Conditions
(from sponsor)		 PGM1-CDG - Phosphoglucomutase 1-Related Congenital Disorder of Glycosylation
Related terms Glycogen Storage Disease XIV
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov