Trials / Completed
CompletedNCT01645189
Safety and Efficacy of Hunterase
To Evaluate the Safety and Efficacy of Hunterase(Idursulfase-beta) in Hunter Syndrome Patients < 6 Years of Age Receiving Idursulfase Enzyme Replacement Therapy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Green Cross Corporation · Industry
- Sex
- Male
- Age
- 5 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to determine the safety and efficacy of once weekly dosing of idursulfase-beta 0.5mg/kg administered by intravenous(IV) infusion for Hunter syndrome patients \< 6 years old.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Hunterase | once weekly, 0.5mg/kg IV infusion |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2013-09-01
- Completion
- 2013-09-01
- First posted
- 2012-07-20
- Last updated
- 2014-07-08
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01645189. Inclusion in this directory is not an endorsement.