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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00806572 |
This is a phase II study to examine the clinical and immunological effects of humanized FcR non-binding anti-CD3 mAb in participants with Type 1 diabetes mellitus (T1DM), and to develop this therapy to prevent the immune destruction leading to β cell loss.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 1 |
Drug: hOKT3gamma1(Ala-Ala) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Phase II Multiple Dose Treatment of Type 1 Diabetes Mellitus With hOKT3gamma1(Ala-Ala) |
Enrollment: | 10 |
Study Start Date: | May 2002 |
Study Completion Date: | August 2007 |
Primary Completion Date: | July 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Treatment: Experimental |
Drug: hOKT3gamma1(Ala-Ala)
3 cycles, six months apart, each consisting of 12 daily infusions with 455-1818ug/m2 hOKT3g1(Ala-Ala)
|
Control: No Intervention |
This is a 2-arm, open-label phase II trial involving 0 or 3 cycles of treatment 6 months apart with hOKT3γ1 (Ala-Ala), over the first year of disease in participants with new onset T1DM. Each cycle consists of 12 daily doses of hOKT3γ1 (Ala-Ala).
Participants will be randomized in a ratio of 2:1 to either the experimental arm or the control arm and will be stratified by study site.
To be eligible, participants must be: male or female between 7-30 years of age, diagnosed with T1DM within the past 6 weeks, have a body weight ≥26 kg at the time of enrollment and have detectable anti-GAD, anti-ICA512/IA-2, or insulin autoantibodies (if the participant has been on insulin ≤10 days). Participants randomized to the experimental group will start the first cycle of hOKT3γ1 (Ala-Ala) within 4-8 weeks of T1DM diagnosis. Each participant randomized to the experimental group will receive 3 cycles of drug treatment, separated by 6 months each. Each cycle consists of 12 days of drug treatment. Both groups will undergo the Mixed Meal Stimulated C-Peptide Test and receive blood draws for mechanistic studies on the same schedule.
Ages Eligible for Study: | 7 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94143 | |
United States, New York | |
Naomie Berrie Diabetes Center, Columbia University | |
New York, New York, United States, 10032 | |
United States, Washington | |
Benaroya Research Institute | |
Seattle, Washington, United States, 98101 |
Principal Investigator: | Kevan C Herold, MD | Yale University |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | ITN007AI, NDB01 |
Study First Received: | December 9, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00806572 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
Diabetes, juvenile diabetes, teplizumab |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |