The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients
关键词
抽象
描述
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.
日期
| 最后验证: | 12/31/2015 |
| 首次提交: | 07/19/2009 |
| 提交的预估入学人数: | 04/07/2011 |
| 首次发布: | 04/10/2011 |
| 上次提交的更新: | 01/14/2016 |
| 最近更新发布: | 01/17/2016 |
| 实际学习开始日期: | 08/31/2011 |
| 预计主要完成日期: | 09/30/2015 |
| 预计完成日期: | 12/31/2015 |
状况或疾病
干预/治疗
Drug: injections
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Omalizumab | |
| Placebo Comparator: Placebo |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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. |
结果
主要结果指标
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]
次要成果指标
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]
