Status:
COMPLETED
Omalizumab to Treat Hyper-IgE (Job's) Syndrome
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Hyper-IgE Syndrome
Job's Syndrome
Eligibility:
All Genders
6-76 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and effectiveness of a laboratory-made antibody called omalizumab in patients with Job's syndrome, or hyper-IgE syndrome (HIES). Patients with HIES have very high l...
Detailed Description
The hyper-IgE syndromes (HIES) are disorder characterized by markedly elevated serum IgE levels, eosinophilia, dermatitis, and recurrent skin and lung infections. The autosomal dominant form of HIES, ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- All Subjects must be at least 6 years of age and no older than 76 years of age (as per original safety studies).
- 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.
- 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.
- 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).
- Weight (Kg) times serum IgE (IU/mL) less than 3,000,000, then as above greater than 63,000, less than 3,000,000.
- Patients in tier II must be 16 years or older.
- Preference will be given to patients with dermatitis.
- Subjects (guardians for younger patients) must be able to give informed consent (or assent as appropriate).
- Subjects must already be signed to other NIH studies on HIES.
- 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.
- Patients participating in protocols at the National Institutes of Health are expected to have a primary physician outside of the NIH.
- EXCLUSION CRITERIA:
- Pregnant or nursing women.
- HIV positive diagnosis.
- Use of any other investigational agent within 30 days of the study.
- Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study.
- Previous anaphylaxis to the study medication.
Exclusion
Key Trial Info
Start Date :
November 24 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00260702
Start Date
November 24 2005
End Date
March 19 2010
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892