Status:
TERMINATED
Inducing Remission in Type 1 Diabetes With Alefacept
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Juvenile Diabetes Research Foundation
Conditions:
New-onset Type 1 Diabetes Mellitus
Eligibility:
All Genders
12-35 years
Phase:
PHASE2
Brief Summary
The purpose of this trial is to test whether a drug called alefacept will slow or halt destruction of the beta cells in the pancreas. If the destruction of the beta cells is stopped, the patients migh...
Detailed Description
T1DM is an autoimmune disease that can emerge suddenly, causing dependence on insulin for life. This means that the immune system (the part of your body that helps fight infections) mistakenly attacks...
Eligibility Criteria
Inclusion
- Recent diagnosis (within 100 days of enrollment) of T1DM
- Positive for at least one diabetes autoantibody (Glutamate decarboxylase \[GAD-65GAD65\], IA2, ZnT8, ICA and Insulin, if obtained within 10 days of the onset of exogenous insulin therapy)
- Peak stimulated C-peptide level \> 0.2 pmol/mL following a mixed-meal tolerance test (MMTT)
- Willingness to provide written informed consent (either the subject or the subject's legally authorized representative).
Exclusion
- Severe reaction or anaphylaxis to human monoclonal antibodies
- History of malignancy or significant cardiovascular disease (including history of myocardial infarction, angina, use of anti-anginal medicines (e.g., nitroglycerin), or abnormal stress test)
- History of recent or ongoing uncontrolled bacterial, viral, fungal, or other opportunistic infections
- Evidence of infection with hepatitis B virus (HBV) as defined by hepatitis B surface antigen, HBsAg; hepatitis C virus (HCV) defined by anti-HCV antibodies; human immunodeficiency virus (HIV); or toxoplasmosis
- Positive tuberculin skin test (PPD)
- Clinically active infection with Epstein-Barr virus (EBV)-EBV viral load ≥ 10,000 copies per 10\^6 PBMCs; cytomegalovirus (CMV) -CMV viral load ≥10,000 copies per mL whole blood; or tuberculosis (TB)
- Diagnosis of liver disease or hepatic enzymes, as defined by ALT and/or AST ≥ 2 times the upper limit of normal
- Prior or current treatment that is known to cause a significant, ongoing change in the course of T1DM or immunologic status, including high-dose inhaled, extensive topical or systemic glucocorticoids
- 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., atypical antipsychotics, diphenylhydantoin, thiazide, or other potassium-depleting diuretics, β-adrenergic blockers, niacin)
- Any of the following hematologic abnormalities, confirmed by repeat tests at least 1 week apart:
- White blood count \<4000/μL or \>14,000/μL;
- CD4+ count below the lower limit of normal;
- Platelet count \<150,000 /μL; or
- Hemoglobin \<10 g/dL.
- Females who are pregnant, lactating, or planning on pregnancy during the 2-year study period
- History of bone marrow transplantation, or autoimmune disease associated with lymphopenia
- Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial
- Prior participation in a clinical trial that could potentially affect T1DM or immunologic status
- Receipt of a live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guérin, and smallpox) in the 6 weeks before enrollment
- Participation in an investigational clinical trial within the last six weeks.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00965458
Start Date
March 1 2011
End Date
April 1 2014
Last Update
July 6 2017
Active Locations (15)
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1
University of Arizona
Tucson, Arizona, United States, 85724
2
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
3
University of California - San Francisco
San Francisco, California, United States, 94143
4
Barbara Davis Center for Childhood Diabetes - University of Colorado
Aurora, Colorado, United States, 80045