Evaluate the Safety and Exploratory Efficacy of GC1119
NCT01653444 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2016-06-24
Summary
The purpose of this study is to evaluate the safety and exploratory efficacy of GC1119 (recombinant human α-galactosidase A) for enzyme replacement therapy in Fabry disease patients.
Conditions
Interventions
- DRUG
-
GC1119
biweekly, IV infusion
Sponsors & Collaborators
-
Green Cross Corporation
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-11-30
- Primary Completion
- 2014-05-31
- Completion
- 2015-10-31
Countries
- South Korea
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