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NCT02067923 · ClinicalTrials.gov registry record
AbATE Follow-Up Study
A clinical trial, sponsored by Yale University.
- Completed
- Registry status
- 44
- Enrollment target
NCT02067923: Completed study, sponsored by Yale University.
NCT02067923 is a clinical trial that has completed, run by Yale University. The registered enrollment target is 44 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02067923 has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- 44 participants
- Enrollment target
Study Summary
This study proposes to conduct a non-interventional, multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal antibody is a humanized antibody that is commonly used to prevent organ rejection. It was give in order to determine whether anti-CD3 mAb treatment can halt the progression of newly diagnosed type 1 diabetes. The overall hypothesis of this study is there will be less change in c-peptide levels of the previously treated group versus the control group.
Primary Outcome
Labs will be obtained to assess beta cell function via c-peptide levels and glucose at 11 time points during the mixed meal tolerance test. Blood samples will be obtained prior to the start of the mixed meal tolerance test to assess auto-antibody status and HbA1c. Approximately 60 cc's of blood will also be obtained for PBMC's and future studies as related to the immunology and genetics of T1DM. A 4 hour urine sample during the MMTT will be collected for C-peptide and Creatinine measurement. We
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2014-02 |
| Est. Completion | 2016-11-17 |
What the finished NCT02067923 record still lists
NCT02067923 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 44 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02067923 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02067923 about?
NCT02067923 is a clinical study titled "AbATE Follow-Up Study". This study proposes to conduct a non-interventional, multi-center trial that will look at C-peptide results from one or two Mixed Meal Tolerance Tests (MMTT) in participants who received anti-CD3 treatment or placebo on the Abate ITN027AI trial. Anti-CD3 monoclonal antibody is a humanized antibody t...
What is the current status of trial NCT02067923?
This trial is currently completed. The enrollment target is 44 participants. The study started on 2014-02. Estimated completion is 2016-11-17.
Who is sponsoring clinical trial NCT02067923?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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