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临床试验/PER-015-15
PER-015-15已完成未知

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 β2 AGONIST (BORA)

ASTRAZENECA PERU S.A.,0 个研究点目标入组 54 人开始时间: 2015年9月8日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
入组人数
54
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

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
12 至 90（—）

入选标准

  • •Informed consent (and/or assent as applicable locally) Patients that enter this study as an adolescent (at Visit 1) will be re-consented using the appropriate ICF at the study visit following their 18th birthday, prior to any study procedures being performed.
  • •Female and male patients who completed the double-blind treatment period in a predecessor study on benralizumab or matching placebo.
  • •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 IP.
  • •For WOCBP only: Have a negative urine pregnancy test prior to administration of
  • •IP at Visit 1.
  • •All male patients who are sexually active must agree to use a double barrier method of contraception (condom with spermicide) from the first dose of IP until 16 weeks after their last dose.

排除标准

  • •Any disorder including but not limited to pulmonary, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, 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
  • •A helminth parasitic infection
  • •Any clinically significant change in physical examination, vital signs, ECG, hematology, 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
  • •Current malignancy or malignancy that developed during a predecessor study
  • •Receipt of live attenuated vaccines within 30 days prior to initiation of treatment
  • •Receipt of immunoglobulin or blood products within 30 days prior to Visit 1
  • •Planned major surgical procedures during the conduct of the study
  • •Previous participation in the present study
  • •Concurrent enrolment in another clinical trial
  • •AstraZeneca staff
  • •Employees of the study centre or any other individuals involved with the conduct of the study or immediate family members of such individuals

研究者

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