Status:
COMPLETED
Anti-CD3 mAb Treatment of Recent Onset Type 1 Diabetes
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
8-30 years
Phase:
PHASE2
Brief Summary
This is a randomized placebo controlled study to test whether a single 14 course of treatment with the anti-CD3 monoclonal antibody, hOKT3gamma1(Ala-Ala),Teplizumab will prevent the loss of insulin se...
Detailed Description
The study design is a double blind placebo controlled trial that will enroll subjects between the ages of 8 - 30 who have had the diagnosis of Type 1 diabetes made 4 - 12 months prior to enrollment. A...
Eligibility Criteria
Inclusion
- age 8 - 30,
- duration of diabetes 4 - 12 months,
- weight greater than 27.5 kg,
- stimulated C-peptide \>= 0.2 pmol/ml
Exclusion
- asthma,
- history of hepatitis C, hepatitis B, HIV
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00378508
Start Date
September 1 2006
End Date
August 1 2013
Last Update
August 13 2021
Active Locations (4)
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1
University of California at San Francisco
San Francisco, California, United States, 94143
2
Barbara Davis Diabetes Center
Aurora, Colorado, United States, 80045
3
Yale University
New Haven, Connecticut, United States, 06520
4
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States, 10194