Treatment With hOKT3gamma1(Ala-Ala) in T1DM
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Multiple Dose Treatment of Type 1 Diabetes Mellitus With hOKT3gamma1(Ala-Ala) |
- 4-hour C-peptide AUC [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Insulin usage [ Time Frame: throughout study ] [ Designated as safety issue: No ]
| 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 |
|---|---|
| Experimental: Treatment |
Drug: hOKT3gamma1(Ala-Ala)
3 cycles, six months apart, each consisting of 12 daily infusions with 455-1818ug/m2 hOKT3g1(Ala-Ala)
Other Name: teplizumab
|
| No Intervention: Control |
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 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.
Eligibility| Ages Eligible for Study: | 7 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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 studies listed; below in 5.1.1 and 5.1.4.3 (f).
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00806572 History of Changes |
| Other Study ID Numbers: | DAIT ITN007AI, NDB01 |
| Study First Received: | December 9, 2008 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Diabetes, juvenile diabetes, teplizumab |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013