Status:
TERMINATED
A Research Trial of Aralast in New Onset Diabetes (RETAIN)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Juvenile Diabetes Research Foundation
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
8-35 years
Phase:
PHASE1
Brief Summary
The drug Alpha-1 Antitrypsin (AAT, Aralast NP) is being tested in this study as an anti-inflammatory drug (a medication that decreases inflammation, which is part of the body's normal ability to fight...
Detailed Description
Researchers are interested in conducting this study to assess whether Aralast NP (AAT, Alpha-1 Antitrypsin ) will help slow the progression of T1DM. Part I of this study has two parts:-1a and -1b: P...
Eligibility Criteria
Inclusion
- Diagnosed with T1DM within the past 100 days (of enrollment)
- Positive for at least one diabetes-related autoantibody (Anti-GAD; Anti-insulin, if obtained within 10 days of the onset of insulin therapy; IA-2 antibody and/or ICA, or ZnT8.)
- Peak stimulated C-peptide level \> 0.2 pmol/mL following a mixed meal tolerance test (MMTT)
Exclusion
- Severe active disease (chronic active hepatitis; cardiac, pulmonary disease, hepatic, renal or immunodeficiency)
- History of any bleeding or clotting factor deficiencies, or stroke
- History of vascular disease or significant vascular abnormalities
- Positive serology of exposure to (hepatitis B virus) HBV, HCV (hepatitis C virus), HIV (human immunodeficiency virus) or toxoplasmosis
- Clinically active infection with EBV (Epstein-Barr virus), CMV (cytomegalovirus), or tuberculosis(TB)
- Prior or current use of oral, inhaled or intranasal glucocorticoids, or any medication known to cause a significant, ongoing change in the course of T1DM or immunologic status
- Prior treatment with Alpha 1-Antitrypsin (Aralast NP, AAT) or hypersensitivity to alpha 1-antitrypsin or human plasma-derived products
- Current or prior (within the last 30 days) use of metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, DPP-IV inhibitors or amylin
- Current use of any medication known to influence glucose tolerance (e.g., beta-blockers, angiotensin-converting enzyme inhibitors, interferons, quinidine anti-malarial drugs, lithium, niacin)
- Females who are pregnant or lactating, or are unwilling to defer pregnancy during study participation
- IgA (immunoglobulin A) deficiency
- Uncontrolled hypertension
- Current life-threatening malignancy
- Any condition that in the investigator's opinion may compromise study participation or may confound the interpretation of the study results.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01183468
Start Date
October 1 2010
End Date
July 1 2013
Last Update
June 13 2018
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
RADY Children's Hospital (University of California, San Diego)
San Diego, California, United States, 92093
2
Barbara Davis Center (University of Colorado)
Aurora, Colorado, United States, 80045
3
Yale University
New Haven, Connecticut, United States, 06520
4
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30309