Treatment With hOKT3gamma1(Ala-Ala) in T1DM
Stopped early · Phase 2
Conditions studied: Diabetes Mellitus, Type 1
In brief
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.
Key facts
- Study ID
- NCT00806572
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 10
- Starts
- 2002-05-01
- Expected to finish
- 2007-08-01
- Last updated by the study team
- 2017-02-08
Who can join
Age: 7 and older, up to 30. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- University of California San Francisco — San Francisco, California, United States
- Naomie Berrie Diabetes Center, Columbia University — New York, New York, United States
- Benaroya Research Institute — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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