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:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT00774358
Eligibility Criteria:
Inclusion Criteria:
* Age: Subjects age greater than 24 months
* Weight: Subjects greater than 12.5 kilograms
* Disease status: WAS classified as Grade 1-4
* Informed Consent: Written informed consent of the subject (if an adult) or parental permission, and assent of the child subject provided justification is made for the inclusion of children in the study
Exclusion Criteria:
* Prior or planned hematopoetic transplant
* WAS classified as currently Grade 5 (Malignancy or autoimmune disease including the following: Crohn's disease, scleroderma, thyroiditis, inflammatory arthritis, diabetes mellitus, oculo-bulbar myasthenia gravis, crescentic IgA glomerulonephritis, cholecystitis, cerebral vasculitis, Stevens-Johnson syndrome and bullous pemphigoid . Not included here are: Hepatitis C virus induced vasculitis, alopecia areata and systemic lupus erythematosus.)
* Known previous reaction to IL-2
* Subjects taking immunosuppressive medications that might alter study results
* Subjects taking nephrotoxic, cytotoxic, cardiotoxic, or hepatotoxic medications (including medications for hypertension)
* Subjects currently taking systemic corticosteroids (not included here: topical and inhaled corticosteroids)
* Subjects taking Interferon alpha
* Use of any other investigational agent in the last 30 days
* Women of childbearing potential not using contraception method(s), as well as women who are breastfeeding
* Subjects with abnormal cardiac, hepatic and CNS function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
24 Months
Study:
NCT00774358
Study Brief:
Protocol Section:
NCT00774358