Status:
COMPLETED
Safety and Pharmacokinetics (PK) of hOKT3g1 (Ala-Ala) in Type 1 Diabetes Mellitus (T1DM)
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Insulin-Dependent
Eligibility:
All Genders
8-30 years
Phase:
PHASE1
Brief Summary
To assess the tolerability and safety of hOKT3g1 (Ala-Ala) after a 12-day dosing regimen administered via intravenous infusion. To assess the pharmacokinetics of hOKT3g1 (Ala-Ala).
Eligibility Criteria
Inclusion
- To be eligible
- participants will have Type 1 diabetes, diagnosed within the previous 12 months and established by standard American Diabetes Association criteria.
- All participants will have autoantibodies: either anti-GAD65, anti-ICA512, or if treated with insulin for less than 7 days, anti-insulin.
- The age range will be between 8 and 30 years; and
- a minimum weight of 34 kg.
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00073255
Start Date
June 1 2003
End Date
December 1 2005
Last Update
January 15 2010
Active Locations (1)
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1
Columbia University
New York, New York, United States, 10032