Compassionate Use of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00244686
First received: October 25, 2005
Last updated: October 9, 2014
Last verified: August 2014

October 25, 2005
October 9, 2014
August 2005
December 2016   (final data collection date for primary outcome measure)
Incidence and severity of adverse events [ Time Frame: length of study ] [ Designated as safety issue: No ]
Incidence and severity of adverse events
Complete list of historical versions of study NCT00244686 on ClinicalTrials.gov Archive Site
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. [ Time Frame: length of study ] [ Designated as safety issue: No ]
  • 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.
Not Provided
Not Provided
 
Compassionate Use of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES)
A Compassionate Use Open-Label Study of Anti IL-5 (Mepolizumab) Treatment in Subjects With Hypereosinophilic Syndrome

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 provided access to treatment in subjects determined by their treating physicians to have life threatening HES and in who there is documented failure to at least 3 standard therapies used to treat HES.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypereosinophilic Syndrome
Drug: mepolizumab
open label investigational product
Other Name: mepolizumab
No Intervention: mepolizumab
Intervention: Drug: mepolizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
December 2016
December 2016   (final data collection date for primary outcome measure)

Inclusion criteria:

  • ≥ 12 years of age
  • Has life-threatening HES as defined by ther treating physician's documented view that likelihood of death is high unless the course of the disease is interrupted.
  • 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 recognized causes of eosinophilia such as connective tissues disease, malignancy) or 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.

  • Has life-threatening HES disease, as defined 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.

Exclusion Criteria:

  • Subjects without HES but with other conditions associated with eosinophilic pathological process such as Churg-Strauss, Wegner'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.
  • Female subjects of child -bearing 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).

  • Pregnant or lactating females unless meets Inclusion criteria
  • Subjects with severe/life-threatening underlying disease unrelated to HES unrelated to HES where life expectancy is estimated to be less than 3 months.
  • Subjects with known lymphoma, eosinophilic leukaemia or pre-leukemia, 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.
  • 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).
  • Subjects with current drug or alcohol abuse where uncertain compliance with medication causes safety risk.
  • subject currently receiving any other investigational product or other investigational intervention.
Both
12 Years and older
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
United States,   United Kingdom,   Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Norway,   Spain,   Switzerland
 
NCT00244686
MHE104317
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP