Compassionate Use Study of Mepolizumab in Hypereosinophilic Syndrome
Research type
Research Study
Full title
A Compassionate Use Open-Label Study of Anti IL-5 (Mepolizumab) Treatment in Subjects with Hypereosinophilic Syndrome.
IRAS ID
42505
Contact name
Jane Apperley
Contact email
Sponsor organisation
GlaxoSmithKline UK Ltd
Eudract number
2007-000838-39
Clinicaltrials.gov Identifier
Research summary
This is a compassionate use study of mepolizumab to provide access to treatment in subjects determined to have life threatening Hypereosinophilic syndrome (HES). HES is a rare (estimated 5000-8000 cases world-wide) blood disorder with sustained overproduction of eosinophils (a type of white blood cell) resulting in progressive organ damage. The signs and symptoms vary depending on the organ involved but HES causes severe impact on quality of life and in some cases becomes life-threatening. Current treatment attempts to delay organ damage but its efficacy is not always adequate and side-effects are significant. Mepolizumab has been provided to 24 subjects with HES and based on initial assessments, was well tolerated, associated with a marked reduction in the hypereosinophilia, improvement in signs and symptoms of HES and quality of life, as well as enabling reduction of steroid use in most subjects. Eligible patients for this study will be over 12 years of age and have life-threatening HES disease with documented failure to at least 3 standard therapies. Because this is a compassionate use program, the projected number of subjects can not be determined. This is a global study. Subjects will receive an initial supply of three monthly infusions. Additional supplies will be shipped following confirmation by the physician that the subject is receiving clinical benefit from mepolizumab and the benefit/risk is positive. Blood samples will be taken prior to each infusion, as per standard of care and 3 months after the last infusion of mepolizumab. AEs and SAEs will be assessed at every visit and all subjects will be assessed for possible rebound effect up to 3 months after the last infusion of mepolizumab. The Compassionate Use Supply Program will continue while mepolizumab is under clinical development for any indication.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
10/H1307/91
Date of REC Opinion
27 Jul 2010
REC opinion
Further Information Favourable Opinion