CTIS2022-502501-15-00招募中1 期
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease - GB43374
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 1,561
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Ability to comply with the requirements of the study protocol, according to the investigator’s best judgment, Completion of the 52-week treatment period in either Study GB43311 or Study GB44332
排除标准
- •Any permanent discontinuation of study drug in parent study, Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study, Any new clinically significant pulmonary disease other than COPD since enrolling in the parent study, Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study since enrolling in the parent study, History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab, QT interval corrected through use of Fredericia’s formula (QTcF) > 450ms if patient is male of QTcF > 470ms if patient is female. For male or female patients with QRS > 120ms: QTcF > 480ms
研究者
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