Treatment With hOKT3gamma1(Ala-Ala) in T1DM
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|ClinicalTrials.gov Identifier: NCT00806572|
Recruitment Status : Terminated (Adverse events related to drug lot)
First Posted : December 11, 2008
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: hOKT3gamma1(Ala-Ala)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Multiple Dose Treatment of Type 1 Diabetes Mellitus With hOKT3gamma1(Ala-Ala)|
|Study Start Date :||May 2002|
|Primary Completion Date :||July 2004|
|Study Completion Date :||August 2007|
3 cycles, six months apart, each consisting of 12 daily infusions with 455-1818ug/m2 hOKT3g1(Ala-Ala)
Other Name: teplizumab
|No Intervention: Control|
- 4-hour C-peptide AUC [ Time Frame: 24 months ]
- Insulin usage [ Time Frame: throughout study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806572
|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|