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An Open-Label Compassionate Use and Long-Term Access Study of Mepolizumab in HES

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00244686
First received: October 25, 2005
Last updated: February 2, 2017
Last verified: February 2017
  Purpose
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for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application.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.

Condition Intervention Phase
Hypereosinophilic Syndrome
Drug: Mepolizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-Label Compassionate Use Access and Long-Term Access Study of Anti IL-5 (Mepolizumab) Treatment in Subjects With Hypereosinophilic Syndrome

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 15 years ]
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and Any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persisting disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment, is associated with drug-induced liver injury will be categorized as SAE.


Secondary Outcome Measures:
  • Blood eosinophil level [ Time Frame: Up to 15 years ]
    Blood eosinophil count measured prior to each administration of mepolizumab. Data based since 2015 only following a revised case report form.

  • Reports of disease control [ Time Frame: Up to 15 years ]
    The level of eosinophilia control is assessed by the investigator on a 3-point categorical scale (improvement, stable, worsening) at every 3rd administration. The level of disease control is assessed similarly.

  • Dose level and time between doses [ Time Frame: Up to 15 years ]
    Determined from investigational product dosing record.


Estimated Enrollment: 300
Study Start Date: August 2005
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participants with Hypereosinophilic Syndrome
Participants will receive mepolizumab therapy with 300mg subcutaneously (SC) every 4 weeks (q4w) for at least 3 administrations. If a subjects disease control worsen then the dose may be increased after at least 3 administrations in a stepwise manner, i.e., 500mg intravenous (IV) q4w for at least 3 administrations, followed by maximum 700mg IV q4w
Drug: Mepolizumab
open label investigational product

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • ≥ 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.

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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00244686

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 115 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00244686     History of Changes
Other Study ID Numbers: MHE104317 
Study First Received: October 25, 2005
Last Updated: February 2, 2017

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

Additional relevant MeSH terms:
Syndrome
Hypereosinophilic Syndrome
Disease
Pathologic Processes
Eosinophilia
Leukocyte Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on February 23, 2017