Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT01661192
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
25 Years
Study:
NCT01661192
Study Brief:
Protocol Section:
NCT01661192