None listed
Conditions
Interventions
All adult patients previously assigned to an active treatment arm in the predecessor study will receive 1 of 2 active dosing regimens of benralizumab and will continue to receive benralizumab
30 mg
placebo (dummy) injections will be administered at the 4-week interim treatment visits in order to maintain the blind).
Sponsors
ASTRAZENECA PERU S.A.,
Eligibility
Age
12 Years to 90 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Czech Republic, France, Germany, Italy, Japan, Korea South, Mexico, Philippines, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Turkey, Ukraine, United Kindgdom, United States, Vietnam
Contacts
Public ContactUrsula Rodriguez-Frias
ASTRAZENECA PERU S.A.
Outcome results
None listed