JPRN-jRCT2080222712未知3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Omalizumab in Patients With Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite H1 Antihistamine Therapy
ovartis Pharma K.K.0 个研究点目标入组 108 人开始时间: 2015年1月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 12age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •* Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time of randomization
- •* Chronic spontaneous urticaria diagnosis for 6 months
排除标准
- •* Weight less than 20 kg
- •* Clearly defined underlying etiology for chronic urticaria other than chronic spontaneous urticaria
- •* Evidence of parasitic infection
- •* Any other skin diseases than chronic spontaneous urticaria with chronic itching
- •* Previous treatment with omalizumab
- •* Contraindications to diphenhydramine
- •* History of anaphylactic shock
- •* History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
- •* History of hypersensitivity to omalizumab or to drugs of similar chemical classes
- •* Pregnant or nursing (lactating) women
- •Other protocol defined inclusion/exclusion may apply
研究者
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