Trials / Withdrawn
WithdrawnNCT01161914
The Safety and Efficacy Study of ISU302 in Patient With Type I Gaucher Disease
A Multi-national Randomized Double Blinded Phase III Study to Evaluate the Safety and Efficacy of ISU302(Imiglucerase for Injection) or Cerezyme in Patient With Type I Gaucher Disease
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- ISU Abxis Co., Ltd. · Industry
- Sex
- All
- Age
- 2 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare and evaluate the efficacy and safety of ISU302, an investigational product, and Cerezyme®, comparator, for Type 1 Gaucher Disease patients
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cerezyme® | administered by IV infusion for a dose of 60 U/kg |
| DRUG | ISU302 | administered by IV infusion for a dose of 60 U/kg |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2011-08-01
- First posted
- 2010-07-14
- Last updated
- 2016-08-23
Source: ClinicalTrials.gov record NCT01161914. Inclusion in this directory is not an endorsement.