Trials / Completed
CompletedNCT01710813
Alglucosidase Alfa Pompe Safety Sub-Registry
A Prospective Safety Sub-Registry to Assess Anaphylaxis and Severe Allergic Reactions, and Severe Cutaneous and Systemic Immune Complex Mediated Reactions With Alglucosidase Alfa Treatment
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 110 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To collect uniform and meaningful data on patients with Pompe disease who experience anaphylaxis, severe allergic reactions, and/or signals of severe cutaneous and/or systemic immune complex-mediated reactions following treatment with alglucosidase alfa.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | alglucosidase alfa | Alglucosidase alfa IV infusion of 20 mg/kg; qow |
Timeline
- Start date
- 2015-03-20
- Primary completion
- 2021-04-20
- Completion
- 2021-04-20
- First posted
- 2012-10-19
- Last updated
- 2021-07-13
Locations
18 sites across 6 countries: United States, Belgium, Czechia, Germany, Italy, Taiwan
Source: ClinicalTrials.gov record NCT01710813. Inclusion in this directory is not an endorsement.