Ignite Creation Date:
2024-05-06 @ 2:32 AM
Last Modification Date:
2024-10-26 @ 11:20 AM
Study NCT ID:
NCT02067923
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2014-02-18
Brief Title:
AbATE Follow-Up Study
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
ITN0127AI Autoimmunity-blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes AbATE Follow-Up Study
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
We propose 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 The first few subjects went on the trial late in 2005 and the last subjects were enrolled in 2009The mixed meal tolerance tests will coincide with approximately 4 years and 6 years post ITN027AI study completion for each participant Those participants who completed the ITN027AI study in 2007 and 2008 will only have a single MMTT
We plan to enroll approximately 77 subjects at 5 sites who were previously active with ITN027AI Both the drug treated and the control group participants will be invited to participate Along with Yale University these sites include the University of California-San Francisco University of Colorado-Barbara Davis Benaroya Research Institute and Pacific Northwest Research Institute -University of Washington The investigators of each of these sites will be asked to contact their patients who were originally on the ITN027AI study
Subjects will be contacted via email or phone to see if they would be interested in participating on this Abate follow-up study Eligible participants will come to the Yale University Church St Research Unit or other participating ITN study site for either 1 or 2 mixed meal tolerance tests to determine their current c-peptide status The available sites for participants to go to include Yale University University of California-San Francisco University of Colorado-Barbara Davis Center Benaroya Research Institute and Pacific Northwest-University of Washington
This first visit will consist of the following an explanation of the study an assessment of inclusionexclusion criteria and documentation of informed consent If the subject meets the inclusionexclusion criteria a complete medical history will be obtained physical examination including vital signs urine pregnancy test if a female of childbearing potential and an assessment of concomitant medications The subject will then have a Mixed Meal Tolerance Tests MMTT with a possible 2nd MMTT with C-Peptide and glucose measurements a year later based on how long it has been since they were on the ITN027AI StudyThe subject will also have a 4 hour urine collection for C-peptide and creatinine during this MMTT If a repeat MMTT is done a year later then another 4 hour urine sample during the MMTT will be collected for C-peptide and Creatinine measurement
We plan to enroll approximately 77 subjects at 5 sites who were previously active with ITN027AI Both the drug treated and the control group participants will be invited to participate Along with Yale University these sites include the University of California-San Francisco University of Colorado-Barbara Davis Benaroya Research Institute and Pacific Northwest Research Institute -University of Washington The investigators of each of these sites will be asked to contact their patients who were originally on the ITN027AI study
Subjects will be contacted via email or phone to see if they would be interested in participating on this Abate follow-up study Eligible participants will come to the Yale University Church St Research Unit or other participating ITN study site for either 1 or 2 mixed meal tolerance tests to determine their current c-peptide status The available sites for participants to go to include Yale University University of California-San Francisco University of Colorado-Barbara Davis Center Benaroya Research Institute and Pacific Northwest-University of Washington
This first visit will consist of the following an explanation of the study an assessment of inclusionexclusion criteria and documentation of informed consent If the subject meets the inclusionexclusion criteria a complete medical history will be obtained physical examination including vital signs urine pregnancy test if a female of childbearing potential and an assessment of concomitant medications The subject will then have a Mixed Meal Tolerance Tests MMTT with a possible 2nd MMTT with C-Peptide and glucose measurements a year later based on how long it has been since they were on the ITN027AI StudyThe subject will also have a 4 hour urine collection for C-peptide and creatinine during this MMTT If a repeat MMTT is done a year later then another 4 hour urine sample during the MMTT will be collected for C-peptide and Creatinine measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None