The purpose of this study is to determine if the drug Alpha-1 Antitrypsin (AAT, Aralast NP)
will preserve beta-cell function and help slow the progression of type 1 diabetes.
Drug: Alpha 1-Antitrypsin (AAT, Aralast NP)
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Full eligibility criteria for NCT01319331
Ages eligible for Study
6 Years to 45 Years
Genders eligible for Study
Accepts Healthy Volunteers
Diagnosis of Type 1 Diabetes Mellitus based on ADA Criteria for fewer than 5 years but more than 100 days
6-45 years of age, inclusive. To assess safety, we will initially enroll 8 patients over the age of 16. Following the last infusion of the 8th patient, we will assess adverse events. As long as there are no stopping criteria met for these 8 patients we will decrease the age criteria down to 6 years old.
C-peptide increase during screening mixed meal tolerance test with a minimal stimulated value of ≥ 0.2 pmol/mL.
Positive for antibodies to insulin (if insulin autoantibody positive only, determination must be within two weeks of insulin initiation), GAD-65, IA-2 or ZnT8
Agree to intensive management of diabetes with an HgbA1c goal of < 7.0%
If female, (a) surgically sterile or (b) postmenopausal or (c) if of reproductive potential, willing to use medically acceptable birth control (e.g. female hormonal contraception, barrier methods or sterilization. ) until 3 months after completion of any treatment period
If male and of reproductive potential, willing to use medically acceptable birth control until 3 months after completion of any treatment period, unless the female partner is postmenopausal or surgically sterile
Serum creatinine ≤ 1.5 x upper limit of normal
AST < 2 times the upper limit of normal
Hematology:WBC > 3000 x 109/L; platelets > 100 x 109/L; hemoglobin > 10.0 g/dL.
Unable or unwilling to comply with the requirements of the study protocol
Body Mass Index (BMI) > 30 kg/m2
Unstable blood sugar control defined as one or more episodes of severe hypoglycemia
(defined as hypoglycemia that required the assistance of another person) within the last 30 days
Previous immunotherapy for T1D
Administration of an experimental agent for T1D at any time or use of an experimental device for T1D within 30 days of screening, unless approved by the study PI
History of any organ transplant, including islet cell transplant
Active autoimmune or immune deficiency disorder (e.g. sarcoidosis, rheumatoid arthritis)
Serum bilirubin > ULN, except those subjects whose abnormal values were attributed to any stable, benign condition (such as Gilbert's Syndrome) may be included
TSH outside the normal range at screening, except those subjects on stable doses of thyroid hormone replacement therapy may be included
Known HIV positivity, active hepatitis B or active hepatitis C infection
Anticipated pregnancy during active dosing or within 3 months after completion of active dosing phase
History of a malignant neoplasm within the previous 5 years (except in situ cervical cancer and curable non-melanoma skin malignancy)
Any social condition or medical condition that would, in the opinion of the investigator, prevent complete participation in the study or that would pose a significant hazard to the subjects' participation
History of active substance abuse within 12 months of screening
A psychiatric or medical disorder that would prevent giving informed consent
Individuals with a history of IgA deficiency
Individuals with a history of hypersensitivity to AAT
All locations for NCT01319331
United States (1)
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
View full eligibility
Tris trial is registered with FDA with number: NCT01319331. The sponsor of the trial is University of Colorado, Denver and it is looking for 12 volunteers for the current phase.
Official trial title: The Effects of Open Label Alpha-1 Antitrypsin on the Progression of Type 1 Diabetes in Subjects With Detectable C-peptide
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