drugset / Trial / NCT00144781
A Dose-optimization Study of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I (MPS I) Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
The main purpose of this study is to evaluate differences in the pharmacodynamic response of 4 Aldurazyme® (laronidase) dose regimens in patients with Mucopolysaccharidosis I (MPS I).
Timeline
- Start
- 2004-12
- Primary completion
- 2006-01
- Completion
- 2006-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | laronidase | Protein / enzyme biologic | 0.58 mg/kg | — |
| Comparator | laronidase | Protein / enzyme biologic | 1.2 mg/kg | — |
| Comparator | laronidase | Protein / enzyme biologic | 1.8 mg/kg | — |