Anti-IL-5 Open-Label Study for Hypereosinophilic Syndrome
The Cincinnati Center for Eosinophilic Disorders at Cincinnati Children's Hospital Medical Center is currently conducting a compassionate use open-label study of Anti-IL-5 (mepolizumab) treatment in subjects with hypereosinophilic syndrome.
GSK will sponsor this compassionate use trial of mepolizumab to treat subjects with HES who have significant clinical disease due to HES, are unresponsive to medication used to treat HES and those who have demonstrated clinical benefit with previous anti IL-5 treatment. The overall objective of this compassionate use supply program is to assess the safety and effectiveness of treatment with Mepolizumab in subjects with severe HES and subjects who previously benefited from anti-IL5 therapy.
Eligibility
Inclusion criteria:
- > 12 years of age
- Meets the diagnostic criteria for Hypereosinophilic Syndrome (HES)
- Has ongoing HES, as judged by documented treatment failure defined as life-threatening or severely disabling signs of HES
Or, Meets the Following Criteria:
- Has previously received mepolizumab through compassionate access or who previously received the Schering-Plough anti IL-5 (SCH55700) compound and who has shown evidence of clinical.
Exclusion criteria:
- Those who have withdrawn from the MHE100185 Phase III study due to treatment failure and who are eligible to receive open label mepolizumab through the MHE100901 extension study
- Female subjects not using an effective method of contraception
- Pregnant or lactating females
- Subjects with history of serious adverse event or allergic reaction to anti-IL5 or other antibody therapy
- Subjects with current drug or alcohol abuse where uncertain compliance with medication causes safety risk
- Subjects with other conditions associated with eosinophilic pathological process such as Churg-Strauss, Wegener's Granulomatosis, atopic disorders, hypersensitivity reactions to parasitic infections, eosinophilic gastroenteropathies
If you are a patient who may be interested in enrolling in this research study or you have further questions, please contact us:
Marc E. Rothenberg, MD, PhD
Bridget Buckmeier
bridget.buckmeier@cchmc.org
513-636-5540
