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Compassionate Use of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES)
This study is currently recruiting participants.
Verified by GlaxoSmithKline, January 2009
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00244686
  Purpose

It is thought that from the efficacy and safety information to date, it is possible that subjects with severe or life-threatening HES, and limited treatment options (unresponsive or intolerant to available HES medication), may benefit from mepolizumab treatment. Such subjects will not be able to access mepolizumab through the aforementioned clinical trials due to the severity of their disease. Waiting for regulatory approval would delay access. It is this population of subjects in whom there is a clear unmet medical need, and in whom the benefit to risk ratio is thought appropriate, who will be considered for compassionate use of mepolizumab. This view is echoed by the physicians caring for subjects with HES.

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.


Condition Intervention Phase
Hypereosinophilic Syndrome
Drug: mepolizumab
Phase III

Drug Information available for: Mepolizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Compassionate Use Open-Label Study of Anti IL-5 (Mepolizumab) Treatment in Subjects With Hypereosinophilic Syndrome

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Incidence and severity of adverse events

Secondary Outcome Measures:
  • Change in end organ assessments; peripheral blood eosinophil levels; disease control; and HES medications. Assessment of mepolizumab dosing requirements as measured by time between doses.

Estimated Enrollment: 50
Study Start Date: September 2005
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • ≥ 12 years of age
  • Meets the diagnostic criteria for Hyper Eosinophilic Syndrome as defined by:

    1. 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).
    2. Subjects with eosinophilia of >1500/ul for less than 6 months who meet the other criteria for HES accompanied by clear evidence of eosinophil tissue infiltration and with exclusion for secondary causes of eosinophilia as above.

      3.Has ongoing HES, as judged by documented treatment failure defined as life-threatening or severely disabling signs of HES in association with documented eosinophil count ≥ 1000µl on > 1 occasion with documented failure to respond to at least one agent in each category of available therapies; a) systemic corticosteroid, b) cytotoxic agent, c) alpha interferon, and d) Imatinib for FIP1L1-PDGRF-alpha fusion gene positive cases, at the appropriate duration and dose.

      OR, MEETS THE FOLLOWING CRITERIA

  • Has previously received mepolizumab through compassionate access, investigator initiated clinical trial or who previously received the Schering-Plough anti IL-5 (SCH55700) compound and who has shown evidence of clinical.

Exclusion Criteria:

  1. 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 in order to maximize the efficacy and safety data collected through the clinical trial.
  2. Female subjects 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 prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; Implants of levonorgestrel; Injectable progestogen; any intrauterine device (IUD) with a documented failure rate of less than 1% per year; oral contraceptives (either combined or progestogen only); Double-barrier methods including diaphragm or condom with a spermicide.
  3. Pregnant or lactating females (but see concept of compassionate use in life-threatening disease below)
  4. Subjects with eosinophilic leukaemia or pre-leukemia in whom anti-IL-5 is not expected to be effective and in whom exacerbation may occur on cessation of anti-IL-5.
  5. Subjects with severe/life-threatening underlying disease unrelated to HES (i.e. organ failure, life expectancy less than 3 months), however, see concept of compassionate use in life-threatening disease below).
  6. Subjects with known lymphoma, hematological malignancy advanced and/or metastatic tumors, subjects receiving chemotherapy, radiotherapy and IL-2 due to potential risk of driving tumor growth with use or withdrawal of mepolizumab.
  7. Subjects with history of serious adverse event or allergic reaction to anti-IL5 or other antibody therapy.
  8. Subjects with current drug or alcohol abuse where uncertain compliance with medication causes safety risk.
  9. Subjects currently receiving chemotherapy, radiotherapy or other investigational interventions.
  10. 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, will not be eligible for this compassionate use program which is restricted to HES.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244686

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

  Show 93 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: MHE104317
Study First Received: October 25, 2005
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00244686  
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Compassionate Use
Mepolizumab
Hypereosinophilic Syndrome
HES
Mepo

Study placed in the following topic categories:
Idiopathic hypereosinophilic syndrome
Hematologic Diseases
Hypereosinophilic Syndrome
Leukocyte Disorders
Hypereosinophilic syndrome
Eosinophilia

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009