The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients
الكلمات الدالة
نبذة مختصرة
وصف
The study will take place as double-blind placebo controlled study. After a first a run-period of 2 months for all participants randomization (1:1) in two group will take place:
Group A: With omalizumab treatment for 6 months; dosage and administration schedule according to body weight and total IgE level (1/2 of the patients). Group B: Placebo (1/2 of the patients). After 4 months of treatment in both groups patients are encouraged to stop all drugs given to reduce mast cell related effects, mainly antihistaminics . In case that disturbing symptoms are reoccurring patients are allowed to restart these drugs. The evaluation will take place after 5 months of treatment.
Finally, a follow up visit 1 and 4 months after the study will take place.
تواريخ
| آخر التحقق: | 12/31/2015 |
| تم الإرسال لأول مرة: | 07/19/2009 |
| تم إرسال التسجيل المقدر: | 04/07/2011 |
| أول نشر: | 04/10/2011 |
| تم إرسال آخر تحديث: | 01/14/2016 |
| آخر تحديث تم نشره: | 01/17/2016 |
| تاريخ بدء الدراسة الفعلي: | 08/31/2011 |
| تاريخ الإنجاز الأساسي المقدر: | 09/30/2015 |
| التاريخ المتوقع لانتهاء الدراسة: | 12/31/2015 |
حالة أو مرض
التدخل / العلاج
Drug: injections
مرحلة
مجموعات الذراع
| ذراع | التدخل / العلاج |
|---|---|
| Experimental: Omalizumab | |
| Placebo Comparator: Placebo |
معايير الأهلية
| الأعمار المؤهلة للدراسة | 18 Years إلى 18 Years |
| الأجناس المؤهلة للدراسة | All |
| يقبل المتطوعين الأصحاء | نعم |
| المعايير | 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. |
النتيجة
مقاييس النتائج الأولية
1. Reduction of mast-cell induced adverse events and symptoms as summarized and calculated from patient's main complaint score and AFIRM score. [10 months]
مقاييس النتائج الثانوية
1. Effect on the consumption or possibility to reduce mast-cell related drugs [10 months]
2. Effect on: - Lung function (FEV1), analysed by standard lung function measurements - blood pressure, - quantitative measurement of pressure-induced wheal and flare. [10 months]
3. Effect on in-vitro parameters (Tryptase levels, density of Fc-IgE-R expression on basophils, Platelet-Activation-Factor (PAF) and cysteinyl leukotriene LTC4) [10 months]
