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4D-310 in Adults With Fabry Disease and Cardiac Involvement

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 21, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Active, Not Recruiting to Recruiting Study sites: 3 to 4 · Primary completion date: Jan 2026 to Jun 2026 · Completion date: Jan 2030 to Jun 2030 · 3 morev4 Show 6 more changesShow less
    • Study sites: 3 to 4
    • Primary completion date: Jan 2026 to Jun 2026
    • Completion date: Jan 2030 to Jun 2030
    • Interventions: 4D-310 (Biological), 4D-310 (Biological), 4D-310 (Biological) to 4D-310 (Biological)
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints shortened, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary completion date: May 31, 2024 to Jan 2026 Completion date: May 31, 2028 to Jan 2030v3 Show 1 more changeShow less
    • Completion date: May 31, 2028 to Jan 2030
  3. Trial status: Recruiting to Active, Not Recruiting Site details revised at 3 of 3 sitesv2 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 and cardiac involvement
Trial Details
NCT Number NCT05629559
Lead Sponsor 4D Molecular Therapeutics
Conditions Fabry Disease
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov