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A Multi-centre, Open-label Extension, Safety Study to Describe the Long-term Clinical Experience of Mepolizumab in Participants With Hypereosinophilic Syndrome (HES) From Study 200622
This is an open-label extension study to Study 200622.In this study subjects from Study 200622 will be continued on 4-weekly dosing with open-label mepolizumab 300 milligram (mg) subcutaneously (SC) for an additional 20 Weeks after completing the 32 Week study assessments post-randomization, while they continue with their background HES therapy per standard of care (SoC). Subjects from study 200622 will participate in this extension study if they had completed the 32-Week treatment period in study 200622 or if they were withdrawn from the study pre-maturely, but were continued in the study per protocol until 32 Weeks from randomization. Data from this study (205203) and 200622 will be combined to provide up to 52-Week exposure data to further characterize the long-term safety profile of mepolizumab and provide additional data on the clinical benefit in HES subjects beyond 32 Weeks. The duration of the study participation will be 20 Weeks for subjects who continue with mepolizumab treatment via MHE104317/MHE112562 after this open-label extension study; and 28 Weeks for subjects who do not continue with MHE104317/MHE112562.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
GSK Investigational Site
La Jolla, California, United States
GSK Investigational Site
New Haven, Connecticut, United States
GSK Investigational Site
Rochester, Minnesota, United States
GSK Investigational Site
Cincinnati, Ohio, United States
GSK Investigational Site
Mayfield Heights, Ohio, United States
GSK Investigational Site
Murray, Utah, United States
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
GSK Investigational Site
La Plata, Buenos Aires, Argentina
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina
GSK Investigational Site
Brussels, Belgium
Start Date
November 13, 2017
Primary Completion Date
December 30, 2019
Completion Date
December 30, 2019
Last Updated
June 23, 2020
102
ACTUAL participants
Mepolizumab
DRUG
Lead Sponsor
GlaxoSmithKline
NCT04018118
NCT03801434
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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