Status:
TERMINATED
TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
12-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate th...
Eligibility Criteria
Inclusion
- Adults 12 to 45 years old who are in good general health
- Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control
- Measurable C-peptide levels
Exclusion
- Females must not be pregnant or lactating and willing to practice contraception
- No prior malignancy, other than non-melanoma skin cancer
- Body Mass Index (BMI) \> 32 at screening
Key Trial Info
Start Date :
July 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00451321
Start Date
July 31 2006
End Date
December 1 2011
Last Update
November 13 2017
Active Locations (17)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294
2
GSK Investigational Site
Walnut Creek, California, United States, 94598
3
GSK Investigational Site
Aurora, Colorado, United States, 80045
4
GSK Investigational Site
Washington D.C., District of Columbia, United States, 20037