Trials / Completed
CompletedNCT01650779
A Study Evaluating Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta
Evaluation of Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta (The INFORM Study)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This is an exploratory study to evaluate changes in glycosphingolipid levels and other (exploratory) Fabry disease parameters in male Fabry disease participants who were previously treated with agalsidase alfa (Replagal®) 0.2 milligram per kilogram (mg/kg) every two weeks (q2w) and who are being switched to agalsidase beta (Fabrazyme®) 1.0 mg/kg q2w.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Agalsidase beta | Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6. |
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
- First posted
- 2012-07-26
- Last updated
- 2014-07-10
- Results posted
- 2014-07-10
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01650779. Inclusion in this directory is not an endorsement.