A Multi-Center, Open-Label Study Evaluating Safety and Clinical Outcomes in Hunter Syndrome Patients 5 Years of Age and Younger Receiving Idursulfase Enzyme Replacement Therapy
- Registry ID
- EUCTR2007-006044-22
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE4
- Sponsor
- Shire Human Genetic Therapies, Inc. (Shire HGT)
- Start date
- 2008-06-03
- Completion date
- 2011-07-08
- Last update
- 2026-08-16
Conditions
- Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome)
Summary
The primary objective of this study is to determine the safety of once weekly dosing of idursulfase 0.5 mg/kg administered by intravenous (IV) infusion for male Hunter syndrome patients ≤ 5 years-old.
Locations
View on source registry