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An Open-label, Single Arm, Repeat Dose, Multi-centre Study to Evaluate the Use of a Safety Syringe for the Subcutaneous Administration of Mepolizumab in Subjects With Severe Eosinophilic Asthma (Study 205667)

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DataCite Commons2025-02-10 更新2026-05-07 收录
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https://search.vivli.org/doiLanding/studies/00004295/isLanding
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资源简介:
This study is aimed to assess the correct real-world use of a safety syringe for the repeat self-administration of mepolizumab SC. This Phase III study will be an open-label, single-arm, repeat-dose, multi-centre study of mepolizumab liquid drug product in a safety syringe (100 milligrams [mg]) administered subcutaneously (SC) every 4 weeks (3 doses) in subjects with severe eosinophilic asthma. Subjects will receive 100 mg mepolizumab SC as a single injection that is self-administered in the thigh, abdomen or administered in the upper arm (caregiver only). Each subject will participate in the study for up to 18 weeks including pre-screening visit, a screening visit and a 12-week treatment period which concludes with end of study assessments (Visit 5) 4 weeks after the last dose of mepolizumab. Approximately 55 Subjects will be enrolled in the study.
提供机构:
Vivli
创建时间:
2019-08-02
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