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AVTX-801 D-galactose Supplementation in SLC35A2-CDG

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv9
  2. Primary and study completion dates: Aug 2026 to Mar 2028
    • Start date: Jun 2025 to Jan 2027
    v8
  3. Enrollment target: 20 to 10v7 Show 5 more changesShow less
    • Primary and study completion dates: Jan 2025 to Aug 2026
    • Start date: Jan 2024 to Jun 2025
    • Primary endpoints revised (3)
    • Eligibility criteria expanded, about 37 words
    • Collaborators expanded, about 17 words
  4. Phase: Phase 2/3 to Phase 2v6 Show 6 more changesShow less
    • Enrollment target: 10 to 20
    • Primary and study completion dates: Jun 2024 to Jan 2025
    • Start date: Oct 2023 to Jan 2024
    • Study sites: 0 to 1
    • Eligibility criteria shortened, about 74 words
    • Study description shortened, about 512 words
  5. Start date: May 2023 to Oct 2023v5
Show 3 earlier versionsHide 3 earlier versions
  1. Re-verified, no change to tracked fieldsv4
  2. Start date: Oct 8, 2022 to May 2023
    • Primary completion date: Jun 30, 2024 to Jun 2024
    • Study completion date: Sep 30, 2024 to Jun 2024
    v3
  3. Primary completion date: Nov 30, 2024 to Jun 30, 2024v2 Show 5 more changesShow less
    • Study completion date: Mar 31, 2025 to Sep 30, 2024
    • Start date: Dec 1, 2022 to Oct 8, 2022
    • Interventions: AVTX-801 (Drug) to AVTX-801 (Drug), Placebo (Drug)
    • Study title shortened, about 16 words
    • Study arms: 1 to 2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 multicenter, randomized, double-blind, placebo-controlled, cross-over study to evaluate the efficacy and safety of AVTX-801 in subjects with SLC35A2-CDG
Trial Details
NCT Number NCT05402384
Lead Sponsor Eva Morava-Kozicz
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Rare Diseases Clinical Research Network, Children's Hospital of Philadelphia
Conditions
(from sponsor)		 SLC35A2-CDG - Solute Carrier Family 35 Member A2 Congenital Disorder of Glycosylation
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov