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 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT00260702
Eligibility Criteria:
-INCLUSION CRITERIA:
1. All Subjects must be at least 6 years of age and no older than 76 years of age (as per original safety studies).
2. All subjects must meet the established diagnostic criteria for HIES as determined by the NIH scoring system, with a score greater than 40, or have a mutation in the STAT3 gene.
3. Baseline values within the following laboratory ranges:
* White blood cell count greater than or equal to 3,300 cells/microliter.
* Absolute neutrophil count greater than or equal to 1,000 cells/microliter.
* Hemoglobin greater than or equal to 10 g/dL.
* Platelet count greater than or equal to 100,000 platelets/micoliter.
4. Women of childbearing potential only: negative urine pregnancy test. Both men and women and their partners must agree to practice abstinence or effective contraception from initiation of the protocol and for 2 months following the last dose of the study drug (effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap, or sponge, or hormonal contraception).
5. Weight (Kg) times serum IgE (IU/mL) less than 3,000,000, then as above greater than 63,000, less than 3,000,000.
6. Patients in tier II must be 16 years or older.
7. Preference will be given to patients with dermatitis.
8. Subjects (guardians for younger patients) must be able to give informed consent (or assent as appropriate).
9. Subjects must already be signed to other NIH studies on HIES.
10. Subjects must be willing to maintain their current regimens for skin care, prophylactic antibiotics (if applicable), and any asthma related oral or inhaled medications. Albuterol rescue medications may be used as needed.
11. Patients participating in protocols at the National Institutes of Health are expected to have a primary physician outside of the NIH.
EXCLUSION CRITERIA:
1. Pregnant or nursing women.
2. HIV positive diagnosis.
3. Use of any other investigational agent within 30 days of the study.
4. Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study.
5. Previous anaphylaxis to the study medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
76 Years
Study:
NCT00260702
Study Brief:
Protocol Section:
NCT00260702