Trials / Completed
CompletedNCT00146770
Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients
A Multicenter, Multinational, Open-Label Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme® (laronidase) patients with MPS I disease. Patients who were previously enrolled in the Phase 3 Double-Blind Study will be enrolled in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Aldurazyme | Placebo for 26 weeks then 0.58 mg/kg Aldurazyme every week for 182 weeks |
| BIOLOGICAL | Aldurazyme | 0.58 mg/kg Aldurazyme every week for 208 weeks |
| BIOLOGICAL | placebo | Placebo for 26 weeks |
Timeline
- Start date
- 2001-05-01
- Primary completion
- 2005-03-01
- Completion
- 2005-03-01
- First posted
- 2005-09-07
- Last updated
- 2015-04-03
- Results posted
- 2009-06-16
Locations
25 sites across 7 countries: United States, Brazil, Canada, Germany, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT00146770. Inclusion in this directory is not an endorsement.