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An Open-label, Phase 1/2 Trial of Gene Therapy 4D-310 in Adults With Fabry Disease

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 8, 2024 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Jun 2023 to Jan 2026 Study sites: 8 to 4 · Completion date: Jun 2027 to Jun 2030v15 Show 2 more changesShow less
    • Study sites: 8 to 4
    • Completion date: Jun 2027 to Jun 2030
  2. Trial status: Recruiting to Active, Not Recruiting Primary completion date: Feb 2024 to Jun 2023 · Completion date: Apr 2027 to Jun 2027 · Site details revised at 8 of 8 sitesv14 Show 3 more changesShow less
    • Primary completion date: Feb 2024 to Jun 2023
    • Completion date: Apr 2027 to Jun 2027
    • Site details revised at 8 of 8 sites
  3. Study sites: 6 to 8 Eligibility criteria shortened, about 69 words · Study arms: 5 to 4 · Study description expanded, about 2 words · 1 morev13 Show 4 more changesShow less
    • Eligibility criteria shortened, about 69 words
    • Study arms: 5 to 4
    • Study description expanded, about 2 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 5 to 6v12
  5. Eligibility criteria expanded, about 7 words Secondary endpoints: 3 to 2v11 Show 1 more changeShow less
    • Secondary endpoints: 3 to 2

    See this version in full on ClinicalTrials.gov ↗

Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 6 to 5 Eligibility criteria revisedv10 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: Feb 2027 to Feb 2024 Eligibility criteria expanded, about 31 words · Secondary endpoints: 5 to 3 · Site contacts updated at 1 of 6 sites · 2 morev9 Show 5 more changesShow less
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: 5 to 3
    • Site contacts updated at 1 of 6 sites
    • Study description shortened, about 1 word
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 5 to 6v8
  4. Re-verified, no change to tracked fieldsv7
  5. Study sites: 4 to 5v6
  6. Start date changed from estimate of Sep 23, 2020 to Sep 1, 2020v5
  7. Site details revised at 1 of 4 sitesv4
  8. Trial status: Not Yet Recruiting to Recruiting Start date: Sep 15, 2020 to Sep 23, 2020 · Site details revised at 4 of 4 sitesv3 Show 2 more changesShow less
    • Start date: Sep 15, 2020 to Sep 23, 2020
    • Site details revised at 4 of 4 sites
  9. Start date: Aug 15, 2020 to Sep 15, 2020 Study sites: 0 to 4v2 Show 1 more changeShow less
    • Study sites: 0 to 4
  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 prospective multicenter, open-label, dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of 4D-310 following a single IV administration. The study population is comprised of adult males and females with Fabry Disease.
Trial Details
NCT Number NCT04519749
Lead Sponsor 4D Molecular Therapeutics
Conditions Fabry Disease
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov