Status:
TERMINATED
Treatment With hOKT3gamma1(Ala-Ala) in T1DM
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
7-30 years
Phase:
PHASE2
Brief Summary
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 t...
Detailed Description
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 co...
Eligibility Criteria
Inclusion
- diagnosed with T1DM within the past 6 weeks
- have a body weight ≥26 kg at the time of enrollment
- have detectable anti-GAD, anti-ICA512/IA-2, or insulin autoantibodies (if the participant has been on insulin ≤10 days).
Exclusion
- Pregnant or lactating females;
- Prior OKT3 treatment;
- Known hypersensitivity to murine products;
- Uncompensated heart failure or fluid overload, recent myocardial infarction;
- History of epilepsy, cancer, active infection, atopic disease, active Grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease, any concurrent autoimmune diseases, asthma;
- Any medical condition that in the opinion of the investigator will interfere with safe completion of the trial;
- Inability to give informed consent;
- Prior participation in a clinical trial that could potentially affect diabetes or immunologic status;
- Participation in a clinical trial within the last 6 weeks;
- HIV positive;
- Positive for Hepatitis B surface antigen or Anti-Hepatitis C antibody;
- Seropositivity for Toxoplasmosis (IgG);
- Lymphopenia (\<1000 lymphocytes/microliter);
- Thrombocytopenia (\<150,000/mm3 platelets);
- Anemia (Hgb \< 10g/dL);
- Vaccination with a live virus within the past 6 weeks;
- Positive PPD skin test;
- Any infectious mononucleosis-like illness within the 3 months prior to enrollment;
- Serologic evidence of acute infection with EBV or CMV based on tests listed and as defined by the protocol.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00806572
Start Date
May 1 2002
End Date
August 1 2007
Last Update
February 8 2017
Active Locations (3)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
Naomie Berrie Diabetes Center, Columbia University
New York, New York, United States, 10032
3
Benaroya Research Institute
Seattle, Washington, United States, 98101