deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00196716

A Study of the Safety and Efficacy of Fabrazyme in Patients With Fabry Disease

A Multicenter, Open-label Study of Low Dose Maintenance Treatment of Fabrazyme (Recombinant Human Alpha-Galactosidase A (R-h Alpha-GAL)) Replacement Therapy in Patients With Fabry Disease

Sponsor: Genzyme, a Sanofi Company

Conditions Fabry Disease
Interventions Fabrazyme (agalsidase beta)
Updated 8 times since 2017 Last updated: Mar 17, 2015 Started: Jun 30, 2003 Primary completion: Apr 30, 2006 Completion: Mar 31, 2007
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Fabry Disease and is currently completed. Genzyme, a Sanofi Company leads this study, which shows 8 recorded versions since 2003 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Dec 2022 · 23 months · monthly snapshotCompleted~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshotCompleted~Jan 2023 – ~Jul 2024 · 18 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 11 months · monthly snapshotCompleted

Change History

8 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Jan 2023 — Jul 2024 [monthly]

    Completed PHASE2

  5. Dec 2022 — Jan 2023 [monthly]

    Completed PHASE2

▶ Show 3 earlier versions

  1. Jan 2021 — Dec 2022 [monthly]

    Completed PHASE2

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  3. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE2

    First recorded

Jun 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Genzyme, a Sanofi Company
Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations