Long Term Treatment Effect of the Safety, Tolerability and Efficacy of AAT in Type 1 Diabetes (AAT Extension)
Type 1 Diabetes, Beta Cell Preservation
About this trial
This is an interventional prevention trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, newly diagnosed, Beta cell preservation
Eligibility Criteria
Inclusion Criteria:
- Subject (or parent/guardian) willing and able to sign an informed consent
- Ability to comply with all study requirements.
- A patient that participated in Study 008 and received all doses of study medication, per protocol.
- Evidence of clinically significant residual beta-cell function demonstrated by MMTT peak stimulated C-peptide concentrations ≥ 0.20 nmol/L (Arm 1 only).
- Age 10-25 (inclusive) years
- If a female is of childbearing potential, the subject is not pregnant or lactating, and will use oral hormonal contraception or other equally effective contraceptive methods throughout the study.
Exclusion Criteria:
- IgA (immunoglobulin A ) deficient subjects.
- Individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis, to plasma products.
- History of life threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products.
- The subject is receiving immunosuppressive or immunomodulating agents or cytotoxic therapy or any medication that in the opinion of the Investigator might interfere with the study.
- Clinically significant intercurrent illnesses, including (but not limited to): cardiac, hepatic, renal, neurological, hematological, neoplastic, immunological, skeletal or other) that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study. Patients with well-controlled, chronic diseases could be possibly included after consultation with the treating physician.
Sites / Locations
- Schneider Children's Medical Center
- Assaf Haroffeh Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
AAT( Alpha 1 Antitrypsin)
Follow up group
Subjects who maintained peak stimulated C-peptide secretion ≥ 0.2nmol/L will continue treatment with AAT according to the dosage group they were allocated to at the previous study(40mg/kg or 60mg/kg or 80mg/kg), intravenously, once a week for 6 consecutive weeks, at 24-week intervals for a duration of ~54 weeks.
Subjects who have not maintained peak stimulated C-peptide secretion ≥ 0.2nmol/L or subjects with peak stimulated C -peptide secretion ≥ 0.2nmol/L who are reluctant to receive additional study drug, will be followed up only with no administration of investigational product