Chronic Spontaneous Urticaria Clinical Trial
Official title:
A Real-world, Prospective, Multicenter Study of Safety and Effectiveness of Xolair® (Omalizumab) in the Treatment of Chronic Spontaneous Urticaria (CSU) in Chinese Adolescents Inadequately Controlled With H1 Antihistamines
This non-interventional, multi-center, prospective post-approval study aims to provide safety and effectiveness data of Xolair® in Chinese adolescents with Chronic Spontaneous Urticaria who remain symptomatic despite H1 antihistamine treatment. The study period is 16 weeks which contains a 12-week treatment period and 4-week safety follow-up.
The study period is 16 weeks which contains a 12-week treatment effect evaluation period and 4-week safety follow up. The primary objective is to evaluate the safety of Xolair® in a real-world setting in Chinese adolescent patients with Chronic Spontaneous Urticaria who remain symptomatic despite H1 antihistamine treatment over a 16-week study period. The secondary objectives are to evaluate the effectiveness (measured by ISS7, UAS7, UCT) of Xolair® and the quality of life (measured by CDLQI) of Chinese adolescent patients over a 12-week treatment period. Data will be collected in conjunction with routine care visits at the site, at Week 4, 8, 12 (recommended scheduled visits). Routine clinical assessments will be conducted, and safety information will be collected. Safety information includes AE/SAE collection, including but not limited to lab tests, vital signs, weight, physical examination etc. No extra study visits, examinations, laboratory tests or procedures other than activities performed in clinical practice will be mandated. ;
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