NCT00482508已完成3 期
A One Year Open-label Extension Study to Assess Long Term Safety and Tolerability of Omalizumab Treatment in Poorly Controlled Moderate to Severe Allergic Asthma Patients Who Participated in the 52-week CIGE24IA04E1 Study
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 95
- 主要终点
- Safety assessed by adverse events, serious adverse events, vital signs and laboratory safety data. A blood sample will be collected at each scheduled visit prior to administration of study medication and analyzed for free and total IgE levels and total
研究概览
简要总结
This study will assess the safety and tolerability of long-term treatment with omalizumab plus current asthma therapy in patients who participated in and successfully completed the treatment period of study CIGE025IA04E1. Patients who participated in CIGE025IA04E1 were perceived by both the patient and the investigator to have benefited from receiving treatment with omalizumab plus current asthma therapy according to best medical practice
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed core study and extension study CIGE24IA05E1 up to and including visit 15, without experiencing any significant drug-related adverse events
- •Patients who have given written informed consent
排除标准
- •Patients who had not received study medication for greater than 84 days since visit 15 of study CIGE24IA05E1
- •Pregnant females or nursing mothers
- •Patients with know hypersensitivity to any ingredients of Omalizumab or related drugs
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Safety assessed by adverse events, serious adverse events, vital signs and laboratory safety data. A blood sample will be collected at each scheduled visit prior to administration of study medication and analyzed for free and total IgE levels and total
次要结局
未报告次要终点
研究者
相似试验
已完成
3 期
Safety and Tolerability of Omalizumab in Adults and Adolescents With Severe Allergic AsthmaAsthmaNCT00482248Novartis132
已完成
3 期
Long-term Safety, Tolerability and Efficacy of Omalizumab in Japanese ChildrenAllergic AsthmaNCT01328886Novartis Pharmaceuticals38
已完成
3 期
An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal PolypsNasal PolypsChronic RhinosinusitisNCT03478930Hoffmann-La Roche249
终止
3 期
Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic AsthmaEosinophilic AsthmaNCT01290887Teva Branded Pharmaceutical Products R&D, Inc.1,052
已完成
3 期
Long-Term Safety Evaluation of Dupilumab in Patients With Asthma (LIBERTY ASTHMA TRAVERSE)AsthmaNCT02134028Sanofi2,282