An Open-Label Compassionate Use and Long-Term Access Study of Mepolizumab in HES
Expanded access is currently available for this treatment.
Verified March 2017 by GlaxoSmithKline
Information provided by (Responsible Party):
First received: October 25, 2005
Last updated: March 15, 2017
Last verified: March 2017
The market authorisation application for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application. On the basis of sponsor's evaluation, participants with life-threatening HES who have documented failure (lack of efficacy or a contra-indication) to at least 3 standard HES therapies (compassionate use) and participants who have participated in a previous GSK sponsored study in HES (long-term access) can be consider for mepolizumab treatment where the country regulation permits. In this study, participants will receive mepolizumab in an open-labelled manner, and limited data will be collected to evaluate the long-term safety and efficacy of mepolizumab.
What is Expanded Access?
||An Open-Label Compassionate Use Access and Long-Term Access Study of Anti IL-5 (Mepolizumab) Treatment in Subjects With Hypereosinophilic Syndrome
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2020 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||12 Years and older (Child, Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- ≥ 12 years of age
- Has life-threatening HES as defined by the 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 >1500cells/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 >1500cells/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.
- Compassionate use: 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
- Long-term access: Entry of subjects who participated in a previous GSK HES study to this study must be supported by the following: Subjects who received mepolizumab (if study treatment is known) in a previous GSK HES study: Documented improvement in symptoms and/or signs of HES following treatment with mepolizumab or Subjects who received mepolizumab or placebo in a previous GSK HES study: The treating physician must confirm a positive benefit/risk ratio, and the anticipated clinical benefit from mepolizumab must outweigh any potential safety or tolerability risk in this study or Subjects who participated in Study 200622 should complete the protocol required assessments for the duration of 32 weeks after randomization. Subsequently, subjects should complete the 20-week assessments in Study 205203, open-label extension (OLE) to Study 200622, prior to being considered for this protocol (MHE104317). In addition, subjects should not have had an adverse event (serious or non-serious) considered related to study treatment while participating in Study 200622 or Study 205203 which resulted in permanent withdrawal of study treatment.
- 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 16 weeks after the last dose.
- Pregnant or lactating females
- 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 a history of or current malignancy: Subjects with a history of or current lymphoma or Subjects with current malignancy or previous history of cancer in remission for less than 12 months prior to the first dose. Subjects that had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded.
- Subjects with history of serious allergic reaction (hypersensitivity/anaphylaxis) to anti-IL5 or other antibody therapy or known or suspected hypersensitivity to any component of mepolizumab, leading to treatment discontinuation
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00244686
||GSK Clinical Trials
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 25, 2005
||March 15, 2017
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 30, 2017