An Open-Label Extension Study to evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients with Eosinophilic Asthma who completed a prior Cephalon-sponsored Study in Eosinophilic Asthma

Teva Branded Pharmaceutical Products R&D, Inc.0 个研究点目标入组 1,000 人开始时间: 2011年5月3日最近更新: 2015年8月17日

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•Patients are included in the study if all of the following criteria are met:
•(a) The patient is male or female, 12 through 75 years of age, with a previous diagnosis of asthma. Patients 12 through 17 years of age are excluded from participating in India and Argentina; patients 66 through 75 years of age are excluded from participating in India.
•(b) Written informed consent is obtained. Patients 12 through 17 years old, where participating, need to provide assent in accordance with local standards.
•(c) Patient must have completed treatment in a previous double-blind asthma exacerbation study or received at least 2 doses of study drug treatment in a pulmonary function study.
•(d) The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 74
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 750
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•Patients are excluded from participating in this study if 1 or more of the following criteria are met:
•(a) The patient has a clinically meaningful comorbidity that would interfere with the study schedule or procedures, or compromise the patient’s safety.
•(b) The patient has another confounding underlying lung disorder (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, or lung cancer).
•(c) The patient is a current smoker.
•(d) The patient is expected to be poorly compliant with study drug administration, study procedures, or visits.
•(e) The patient has any aggravating factors that are inadequately controlled (eg, gastroesophageal reflux disease [GERD]).
•(f) Female patients of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after the end of treatment visit. Acceptable methods of contraception include barier method with spermicide, abstinence, intrauterine device (IUD), or steroidal contraceptive (oral, transdermal, implanted, and injected).
•(g) The patient has a current infection or disease that may preclude assessment of asthma.

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