Dupilumab Compassionate Use Study

Sally E. Wenzel MD0 个研究点开始时间: 2017年1月13日最近更新: 2018年3月7日

适应症

试验速览

阶段: 不适用
状态: Approved For Marketing
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

This is a single patient expanded access, compassionate and non-emergency use study that provides patients with severe asthma, who do not qualify for ongoing clinical trials with dupilumab, access to this investigational treatment.

详细描述

This study is being undertaken to determine whether dupilumab has efficacy in extremely severe asthma, and to allow a very severe asthma patient, who has been tried on nearly every immunosuppressive drug, early access to a potentially effective therapy.

The patient will continue in the study indefinitely. Safety will be evaluated and serious adverse events will be reported.

研究设计

研究类型: Expanded Access

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Sever systemic corticosteroid dependent asthma for more than 5 years

排除标准

•Disease other than asthma
•Circulation eosinophils more than 1500/ul
•Current smoker or more than 10 pack years
•This is a single-patient study. The University of Pittsburgh site is not enrolling new patients.

研究者

发起方

Sally E. Wenzel MD

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Sally E. Wenzel MD

Professor of Medicine

University of Pittsburgh

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