Hypereosinophilic Syndrome MedDRA version: 20.0 Level: PT Classification code 10048643 Term: Hypereosinophilic syndrome System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Sponsors
GlaxoSmithKline Resaearch and Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. = 12 years of age 2. Has life threatening HES disease as defined by: The treating physician’s documented view that likelihood of death is high unless the course of the disease is interrupted 3. Meets the diagnostic criteria for Hyper Eosinophilic Syndrome as defined by: Eosinophilia >1500/ul for at least 6 months with evidence of symptoms and signs of organ system involvement or dysfunction that can be directly related to eosinophilia (with no evidence of parasitic, allergic or other recognised causes of eosinophilia such as connective tissues disease, malignancy). or Eosinophilia of >1500/ul for less than 6 months and meet the other criteria for HES accompanied by clear evidence of eosinophil tissue infiltration and with exclusion for secondary causes of eosinophilia as above. 4. Has life-threatening HES disease, as defined in #2 above, with documented failure (lack of efficacy or a contra-indication) to at least 3 standard therapies (corticosteroids, cytotoxic agents, immunomodulatory therapy, and Imatinib mesylate) at the appropriate duration and dose. or 5. Has received clinical benefit as assessed by the treating investigator during participation in the MHE100901 study. Evidence of clinical benefit during study MHE100901 will be documented at entry to the compassionate use program. These patients do not have to meet Inclusion criteria #2-4. Entry to the compassionate use programme must be evidenced by both of the following: • Documented improvement in symptoms and/or signs of HES following treatment with mepolizumab in studies MHE100185/MHE100901. • A positive benefit/risk ratio as determined by the treating physician. The clinical benefit due to mepolizumab over the period of treatment in studies MHE100185/MHE100901 must outweigh any safety or tolerability risk over that period. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects without HES but with other conditions associated with eosinophilic pathological process such as Churg-Strauss, Wegener’s Granulomatosis, atopic disorders, hypersensitivity reactions to parasitic infections, eosinophilic gastroenteropathies, will not be eligible for this compassionate use program which is restricted to life threatening HES. 2. Female subjects of childbearing potential who are not using an effective method of contraception: Consistent and correct use of one of the following acceptable methods of birth control for one month prior to the start of the investigation product and three months after the last dose: Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; abstinence, implants of levonorgestrel; injectable progestogen; any intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year; estrogenic vaginal ring, percutaneous contraceptive patches, oral contraceptives (either combined or progestogen only); double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository). 3. Pregnant or lactating females unless meets Inclusion Criteria. 1-3 4. Subjects with severe/life-threatening underlying disease unrelated to HES where life expectancy is estimated to be less than 3 months. 5. Subjects with known lymphoma, eosinophilic leukaemia or pre-leukemia, hematological malignancy advanced and/or metastatic tumors, subjects receiving chemotherapy or radiotherapy or IL-2 due to potential risk of driving tumor growth with use or withdrawal of mepolizumab. 6. Subjects with history of serious adverse event or allergic reaction to anti-IL5 or other antibody therapy or known or suspected hypersensitivity to any component of the investigational product (mepolizumab). 7. Subjects with current drug or alcohol abuse where uncertain compliance with medication causes safety risk. 8. Subjects currently receiving any other investigational product or other investigational interventions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the safety and effectiveness of long term exposure to mepolizumab in subjects with life-threatening HES and in subjects who received clinical benefit while participating in Study MHE100901.;Main Objective: To provide access to therapy to subjects with life threatening HES who have documented failure with standard treatments and for subjects who received clinical benefit while participating in Study MHE100901. In addition, limited data will be collected to assess the safety and effectiveness of treatment with Mepolizumab in these subjects; Secondary Objective: To assess the adverse event profile associated with mepolizumab therapy in this population of subjects with severe HES. To characterize the overall efficacy response of subjects treated with mepolizumab through this compassionate use program. To characterize individual dosing requirements for control of disease (level and frequency). | — |
Countries
Belgium, France, Germany, Norway, Poland, Spain, United Kingdom
Outcome results
None listed