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The Safety and Efficacy Study of ISU302 in Patient With Type I Gaucher Disease

NCT01161914 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2016-08-23

No results posted yet for this study

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

  • Gaucher Disease

Interventions

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

Sponsors & Collaborators

  • ISU Abxis Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01161914 on ClinicalTrials.gov