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 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT01333293
Eligibility Criteria:
Inclusion criteria:
* Histological proven mastocytosis (cutaneous or systemic);
* Diagnosis made by one marrow unction and/or skin biopsy or other histological work up;
* Age: 18-70 years
Exclusion criteria
* Age \<18 years;
* Known hypersensitivity to omalizumab or any of its components;
* History of cancer in previous 5 years;
* Patients with serious infections;
* Patients with active tuberculosis or undergoing anti-TB therapy;
* Patients currently treated with systemic immunosuppressive agents;
* Female patients who are pregnant or breast feeding;Contraception must be performed by a save reliable and accept method such as oral or implanted contraceptives, intravaginal or male preservatives or permanent methods such as tubal ligation.
* Patients with known positivity for human immunodeficiency virus (HIV). HIV screening will be performed by an HIV 1/2 Antibody-detection test.
Note: Specific immunotherapy for insect sting allergy is no exclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01333293
Study Brief:
Protocol Section:
NCT01333293