In patients with systemic and/or cutaneous mastocytosis, is omalizumab (Xolair) in addition to standard care more effective in the management of symptoms than standard care alone? A randomized, placebo-controlled, double blind, parallel design study

ovartis Pharmaceuticals0 个研究点目标入组 30 人开始时间: 2013年10月1日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•1. Over 18 years of age;
•2. A diagnosis of Indolent Systemic Mastocytosis, OR
•Smouldering Systemic Mastocytosis, OR
•Aggressive Systemic Mastocytosis, OR
•Cutaneous Mastocytosis as per WHO current guidelines, with satisfaction of Valent 2007 criteria for Mastocytosis in the Skin (Valent P, Akin C, Escribano L et. al. Standards and Standardization in Mastocytosis: Consensus Statements on Diagnosis, Treatment Recommendations and Response Criteria. Eur J Clin Invest 2007, 37 (6); 435 – 453.);
•3. Breakthrough symptoms of disease despite maximal tolerated conventional therapy.

•1. Pregnancy (a beta-HCG and pregnancy counseling will be performed for all female patients of child-bearing age).
•2. Terminal illness
•3. Associated haematological clonal non-mast cell lineage disease or mast cell leukaemia
•4. Beta blocker use
•5. Unable to give consent
•6. Known sensitivity to study drug(s) or class of study drug(s)
•7. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
•8. Use of any other investigational agent in the last 30 days

发起方

ovartis Pharmaceuticals