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Trial record 1 of 1 for:    GSK Anti-IL5 MHE 104317 Mepolizumab
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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for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application.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

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site Completed
Birmingham, Alabama, United States, 35249
United States, Alaska
GSK Investigational Site Completed
Anchorage, Alaska, United States, 99508
United States, California
GSK Investigational Site Completed
Anaheim, California, United States, 92807
GSK Investigational Site Completed
San Diego, California, United States, 92111
GSK Investigational Site Recruiting
Stanford, California, United States, 94305-5821
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Colorado
GSK Investigational Site Recruiting
Denver, Colorado, United States, 80206
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Connecticut
GSK Investigational Site Recruiting
New Haven, Connecticut, United States, 06520
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Florida
GSK Investigational Site Completed
Jacksonville, Florida, United States, 32207
GSK Investigational Site Completed
Port St. Lucie, Florida, United States, 34952
GSK Investigational Site Recruiting
Weston, Florida, United States, 33331
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Georgia
GSK Investigational Site Recruiting
Atlanta, Georgia, United States, 30322-1047
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Iowa
GSK Investigational Site Recruiting
Ames, Iowa, United States, 50010
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Waterloo, Iowa, United States, 50702
United States, Maryland
GSK Investigational Site Recruiting
Bethesda, Maryland, United States, 20892
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Massachusetts
GSK Investigational Site Recruiting
Boston, Massachusetts, United States, 02115
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Boston, Massachusetts, United States, 02215
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Michigan
GSK Investigational Site Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Southfield, Michigan, United States, 48075
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Minnesota
GSK Investigational Site Recruiting
Rochester, Minnesota, United States, 55905
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Rochester, Minnesota, United States, 55905
United States, Missouri
GSK Investigational Site Recruiting
Chesterfield, Missouri, United States, 63017
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Montana
GSK Investigational Site Completed
Missoula, Montana, United States, 59807
United States, New Jersey
GSK Investigational Site Completed
Englewood, New Jersey, United States, 07631
United States, New York
GSK Investigational Site Recruiting
New York, New York, United States, 10029
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
New York, New York, United States, 10032
GSK Investigational Site Completed
Rochester, New York, United States, 14642
GSK Investigational Site Terminated
Rochester, New York, United States, 14642
United States, North Carolina
GSK Investigational Site Recruiting
Chapel Hill, North Carolina, United States, 27599-7110
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, North Dakota
GSK Investigational Site Completed
Fargo, North Dakota, United States, 58122
United States, Ohio
GSK Investigational Site Completed
Cincinnati, Ohio, United States, 45229
GSK Investigational Site Recruiting
Cleveland, Ohio, United States, 44195
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Columbus, Ohio, United States, 43219
GSK Investigational Site Completed
Mayfield Heights, Ohio, United States, 44124
United States, Oklahoma
GSK Investigational Site Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Weatherford, Oklahoma, United States, 73096
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Oregon
GSK Investigational Site Terminated
Portland, Oregon, United States, 97227
United States, Pennsylvania
GSK Investigational Site Recruiting
Danville, Pennsylvania, United States, 17822
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Philadelphia, Pennsylvania, United States, 19104
GSK Investigational Site Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Pittsburg, Pennsylvania, United States, PA 15213
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, South Carolina
GSK Investigational Site Completed
Charleston, South Carolina, United States, 29425
GSK Investigational Site Completed
Columbia, South Carolina, United States, 29203
GSK Investigational Site Recruiting
Greenville, South Carolina, United States, 29615
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Tennessee
GSK Investigational Site Completed
Lebanon, Tennessee, United States, 37087
United States, Texas
GSK Investigational Site Completed
Austin, Texas, United States, 78705
GSK Investigational Site Recruiting
Houston, Texas, United States, 77030
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Utah
GSK Investigational Site Recruiting
Salt Lake City, Utah, United States, 84132
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Vermont
GSK Investigational Site Completed
Burlington, Vermont, United States, 05401
United States, Virginia
GSK Investigational Site Completed
Harrisonburg, Virginia, United States, 22801
GSK Investigational Site Recruiting
Richmond, Virginia, United States, 23298
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
United States, Washington
GSK Investigational Site Recruiting
Seattle, Washington, United States, 98109-4725
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Seattle, Washington, United States, 98115
United States, Wisconsin
GSK Investigational Site Completed
La Crosse, Wisconsin, United States, 54601
GSK Investigational Site Recruiting
Madison, Wisconsin, United States, 53792
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Onalaska, Wisconsin, United States, 54650
Australia, Australian Capital Territory
GSK Investigational Site Recruiting
Garran, Australian Capital Territory, Australia, 2605
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Australia, New South Wales
GSK Investigational Site Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Sydney, New South Wales, Australia, 4001
Australia, Victoria
GSK Investigational Site Recruiting
Melbourne, Victoria, Australia, 3004
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Australia, Western Australia
GSK Investigational Site Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
West Perth, Western Australia, Australia, 6005
Belgium
GSK Investigational Site Terminated
Brugge, Belgium, 8000
GSK Investigational Site Completed
Bruxelles, Belgium, 1070
GSK Investigational Site Recruiting
Bruxelles, Belgium, 1070
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Edegem, Belgium, 2650
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Leuven, Belgium, 3000
GSK Investigational Site Recruiting
Leuven, Belgium, 3000
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Canada, British Columbia
GSK Investigational Site Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Vancouver, British Columbia, Canada, V6H 3V4
Canada, Manitoba
GSK Investigational Site Recruiting
Winnipeg, Manitoba, Canada, R3C 0N2
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Canada, Ontario
GSK Investigational Site Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
France
GSK Investigational Site Recruiting
Aurillac Cedex, France, 15002
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Bastia Cedex, France, 20604
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Bordeaux, France, 33075
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Dijon, France, 21079
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Lille Cedex, France, 59037
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Marseille cedex 20, France, 13915
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Montpellier, France, 34295
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Nice, France, 06202
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Paris, France, 75018
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Pierre Benite, France, 69495
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Saint-Etienne, France, 42055
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Strasbourg, France, 67098
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Suresnes, France, 92150
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Toulouse Cedex 9, France, 31059
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Germany
GSK Investigational Site Recruiting
Kirchentellinsfurt, Baden-Wuerttemberg, Germany, 72138
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Muenchen, Bayern, Germany, 80802
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Regensburg, Bayern, Germany, 93053
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Duesseldorf, Nordrhein-Westfalen, Germany, 40225
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Essen, Nordrhein-Westfalen, Germany, 45122
GSK Investigational Site Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Berlin, Germany, 12200
GSK Investigational Site Recruiting
Berlin, Germany, 13353
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Terminated
Bremen, Germany, 28177
Italy
GSK Investigational Site Completed
Bologna, Emilia-Romagna, Italy, 40138
Netherlands
GSK Investigational Site Completed
Amsterdam, Netherlands, 1091 AC
GSK Investigational Site Completed
Groningen, Netherlands, 9713 GZ
Norway
GSK Investigational Site Recruiting
Tromsø, Norway, 9038
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Spain
GSK Investigational Site Terminated
Madrid, Spain, 28046
Switzerland
GSK Investigational Site Terminated
Bern, Switzerland, 3010
GSK Investigational Site Terminated
Zurich, Switzerland, 8027
GSK Investigational Site Terminated
Zürich, Switzerland, 8091
United Kingdom
GSK Investigational Site Terminated
Sunderland, Tyne & Wear, United Kingdom, SR4 7TP
GSK Investigational Site Terminated
Abergavenny, Manmouthshire, United Kingdom, NP7 7EG
GSK Investigational Site Completed
Aylesbury, United Kingdom, HP21 8AL
GSK Investigational Site Recruiting
Cardiff, United Kingdom, CF14 4XW
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Recruiting
London, United Kingdom, W12 0HS
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
GSK Investigational Site Completed
Newcastle Upon Tyne, United Kingdom, NE1 4LP
GSK Investigational Site Completed
Sheffield, United Kingdom, S10 2JF
GSK Investigational Site Terminated
Sheffield, United Kingdom, S10 2TH
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 17, 2017