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Agalsidase Beta Long-Term Treatment Outcome for Fabry Disease Patients With IVS4 Mutation in Taiwan

StatusActive, Not Recruiting
PhaseNot specified
SponsorSanofi
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 57 days later Sep 10, 2026 → Nov 6, 2026
See other at-risk trials from Sanofi

Record History

  1. Primary and study completion pushed from Sep 10, 2026 to Nov 6, 2026 Eligibility criteria expanded, about 28 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 28 words
  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 100 to confirmed 78 · Primary and study completion dates: Sep 4, 2026 to Sep 10, 2026v5 Show 2 more changesShow less
    • Enrollment target: estimated 100 to confirmed 78
    • Primary and study completion dates: Sep 4, 2026 to Sep 10, 2026
  4. Re-verified, no change to tracked fieldsv4
  5. Study sites: 1 to 5v3
  6. Re-verified, no change to tracked fieldsv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sanofi
284 trials monitored
See 12 trials at risk
This is a national, multicenter, observational, cohort study designed to assess clinical outcomes upon agalsidase beta treatment, to characterize the clinical manifestations, and to collect the natural history on male and female Fabry disease adult patients who carry the GLA IVS4. This study aims to retrospectively and prospectively investigate the disease natural history, clinical manifestations, and the treatment outcomes upon agalsidase beta in Fabry disease (FD) patients carrying the GLA IVS4 mutation from medical records, physician assessments, and patient-reported outcomes.
Trial Details
NCT Number NCT06052800
Lead Sponsor Sanofi
Conditions Fabry Disease
Enrollment 78 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov