An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older with Severe Eosinophilic Asthma

Teva Branded Pharmaceutical Products R&D, Inc.0 个研究点目标入组 360 人2017年2月21日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Teva Branded Pharmaceutical Products R&D, Inc.
入组人数: 360
状态: 进行中（未招募）
最后更新: 8年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2017年2月21日

结束日期

待定

最后更新

8年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Teva Branded Pharmaceutical Products R&D, Inc.

入排标准

入选标准

•Patients may only be included in the study if they meet all of the following criteria:
•a. Written informed consent is obtained. A patient 12 through \<18 years of age must provide assent, and their parent(s) or legal guardian(s) must provide consent.
•b. Male or female patient 12 years or older with eosinophilic asthma who was previously randomized and completed the treatment period in either of the double\-blind, placebocontrolled studies (Study 30025 or 30027\) for sc reslizumab and who by the assessment of the Principal Investigator can safely participate in this study.
•Adolescents from Study 30025 must also complete the early follow\-up visit before being eligible for this study.
•c. Unless surgically sterile or postmenopausal, female patients must have a negative urine pregnancy test at baseline. Definitions of sterile and postmenopausal are given in Protocol Appendix E.
•d. Females of childbearing potential (not surgically sterile or postmenopausal) must have an exclusively same\-sex partner or use a medically acceptable method of contraception and must agree to continue the use of this method for the duration of the study and for 5 months after discontinuation of the study drug. Acceptable methods of contraception include intrauterine device, steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, bilateral tubal occlusion, and partner vasectomy.
•e. The patient must be willing and able to comply with study restrictions and willing to return to the investigational center for the follow\-up procedures and assessments as specified in this protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 25
•F.1\.2 Adults (18\-64 years) yes

排除标准

•Patients will be excluded from participating in this study if they meet any of the following criteria:
•a. Patient has received any intravenous or sc reslizumab administration in any previous clinical trial other than Studies 30025 and 30027\.
•b. Patient withdrew early (discontinued from treatment) from either of the placebocontrolled reslizumab studies, Studies 30025 and 30027, for any reason.
•c. The patient has any clinically significant, uncontrolled medical condition (treated or untreated) that would interfere with the study schedule or procedures and interpretation of efficacy results or would compromise the patient’s safety.
•d. The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis eosinophilic granulomatosis with polyangiitis \[also known as Churg\-Strauss syndrome], or allergic bronchopulmonary
•aspergillosis).
•e. The patient has a known/diagnosed hypereosinophilic syndrome.
•f. The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non\-melanoma skin cancers.
•g. The patient is a pregnant or lactating woman or intends to become pregnant during the study or within 5 months after the last dose of study drug. Administration of IMP will be discontinued for any female patient who becomes pregnant during the study.
•h. The patient required treatment for an asthma exacerbation within 4 weeks of screening or during the screening. (Note: This is required only in patients who did not rollover seamlessly from Study 30025 or 30027, ie, had a gap between placebo\-controlled study