View Clinical Trial (Medical Research Study)
The Effects of Open Label Alpha-1 Antitrypsin on the Progression of Type 1 Diabetes in Subjects With Detectable C-peptide
| City: |
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Aurora |
| State: |
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Colorado |
| Zip Code: |
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80045 |
| Conditions: |
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Diabetes - Type 1 Diabetes |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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| NCT ID: |
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NCT01319331 |
| Primary Contact: |
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Lisa Meyers
Phone: 303-724-6893
Email: lisa.meyers@ucdenver.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Aurora, Colorado 80045
United States
Dominic DiDomenico
Phone: 303-724-5687
Email: dominic.didomenico@ucdenver.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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