JPRN-jRCT2080223242已完成2 期
An Open Label, Multicenter, Extension Study to Evaluate the Long-term Safety of QGE031 240 mg s.c. Given Every 4 Weeks for 52 Weeks in Chronic Spontaneous Urticaria (CSU) Patients Who Completed Study CQGE031C2201
ovartis Pharma K.K.0 个研究点目标入组 36 人开始时间: 2016年6月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
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
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •*Patients eligible for inclusion in this study have to fulfill all of the following criteria:
- •a. Written informed consent must be obtained before any assessment is performed.
- •b. Patients who complete the treatment epoch in study CQGE031C2201 and complete at least Visit 203 (Week 32 of the follow-up epoch,>=16 weeks after last injection) and present with active disease as defined by UAS7 >=12.
- •c. Patients must not have any missing eDiary entries in the 7 days prior to Visit 301 (patients are allowed to repeat until this criterion is met).
- •d. Willing and able to complete a daily symptom eDiary for the duration of the study and adhere to the study visit schedules.
排除标准
- •*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
- •*Contraindications to or hypersensitivity to fexofenadine, loratadine, cetirizine, or epinephrine
- •*History of anaphylaxis
- •*History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
- •*History of hypersensitivity to any of the study drugs or its components of similar chemical classes
- •*Pregnant or nursing (lactating) women
- •Other protocol defined inclusion/exclusion may apply
研究者
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