Trials / Completed
CompletedNCT00140621
A Safety and Efficacy Study of Fabrazyme® Replacement Therapy in Patients With Cardiac Fabry Disease
A Multicenter Open-label Study of the Safety and Efficacy of α-galactosidase A (R-h α-GAL) Replacement Therapy in Patients With Cardiac Fabry Disease
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 20 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and safety of agalsidase beta (Fabrazyme \[recombinant form\]) administered by intravenous drip infusion in participants with cardiac Fabry disease. Participants participated for 4 weeks or less in the baseline period and 156 weeks for the treatment period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Agalsidase beta |
Timeline
- Start date
- 2005-07-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2005-09-01
- Last updated
- 2015-05-12
- Results posted
- 2015-04-15
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT00140621. Inclusion in this directory is not an endorsement.