A Multicentre, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting ?2 Agonist (BORA)

AstraZeneca AB0 个研究点目标入组 2,550 人开始时间: 2015年2月25日最近更新: 2018年7月23日

适应症

试验速览

暂无简介。

•1. Informed consent (and/or assent as applicable locally) for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent(s)/guardian(s)) and according to international guidelines and/or applicable European Union guidelines.
•2. Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
•3. Women of childbearing potential (WOCBP) must agree to use a highly effective form of birth control throughout the study duration and for 16 weeks after the last dose of Invesigational Product (IP)
•4. For WOCBP only: Have a negative urine pregnancy test prior to administration of IP at Visit 1.
•5. All male patients who are sexually active must agree to use a method of contraception from the first dose of IP until 16 weeks after their last dose. The method of contraception must be consistent with local regulations, but at a minimum is to use a condom during sexual intercourse.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 158
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2315
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 77

•1.Any disorder including but not limited to pulmonary, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairment that is not stable in the opinion of the Investigator and could:
•-Affect the safety of the patient throughout the study
•-Influence the findings of the studies or their interpretations
•-Impede the patient?s ability to complete the entire duration of study
•2.A helminth parasitic infection diagnosed during a predecessor study that has either not been treated, has been incompletely treated or has failed to respond to standard of care therapy
•3.Any clinically significant change in physical examination, vital signs, electrocardiogram (ECG), haematology, clinical chemistry, or urinalysis during a predecessor study which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or interfere with the patient?s ability to complete the entire duration of the study
•4.Current malignancy or malignancy that developed during a predecessor study (subjects that had basal cell carcinoma, localized squamous cell carcinoma of the skin which was resected for cure, or in situ carcinoma of the cervix that has been treated/cured will not be excluded).

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