Status:
COMPLETED
Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
8-30 years
Phase:
PHASE2
Brief Summary
Anti-CD3 monoclonal antibody (a.k.a. hOKT3gamma1 \[Ala-Ala\],teplizumab, MGA031) is a humanized antibody that is commonly used to prevent organ rejection. The purpose of this study is determine whethe...
Detailed Description
Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks insulin-producing beta cells in the pancreas. Without these cells, the body cannot maintain proper blood glucose ...
Eligibility Criteria
Inclusion
- Diagnosis of type 1 diabetes (according to American Diabetes Association \[ADA\] criteria) within the 8 weeks prior to study entry
- Weigh at least 25 kg (55 lbs)
- Insulin autoantibodies assessed within 10 days of any insulin use OR anti-glutamic acid decarboxylase (GAD) autoantibodies OR anti-ICA512/IA-2 autoantibodies
- Subjects or guardian(s) willing to provide informed consent
Exclusion
- Prior participation in a clinical trial that could potentially affect diabetes condition or immunologic status
- Participation in another investigational clinical trial within the 6 weeks prior to study entry
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00129259
Start Date
September 1 2005
End Date
March 1 2011
Last Update
May 22 2017
Active Locations (7)
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1
The Diabetes Center at UCSF
San Francisco, California, United States, 94143
2
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80262
3
Yale University
New Haven, Connecticut, United States, 06520
4
Medical College of Georgia
Augusta, Georgia, United States, 30912