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Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome - Article


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Kleine-Levin syndrome

 




Clinical Trial: Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome

This study is currently recruiting patients.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline

Purpose

This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticosteroid reduction, and decrease of signs and symptoms of Hypereosinophilic Syndrome.

Condition Treatment or Intervention Phase
Hypereosinophilic Syndrome
Hypereosinophilia
 Drug: mepolizumab
Phase III

MedlinePlus related topics:  Blood and Blood Disorders

Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

  • Participation in study 100185
  • Not pregnant or nursing

Exclusion criteria:

  • Significantly abnormal laboratory values
  • Abnormal cardiac function - angina, myocardial infarction
  • Pregnancy

Location and Contact Information


California
      San Diego,  California,  92103,  United States; Not yet recruiting
Study Coordinator  619-294-6241 

Colorado
      Denver,  Colorado,  80206,  United States; Not yet recruiting
Study Coordinator  303-398-1786 

Maryland
      Bethesda,  Maryland,  20892,  United States; Recruiting
Study Coordinator  301-402-0265 

Massachusetts
      Boston,  Massachusetts,  02215,  United States; Not yet recruiting
Study Coordinator  617-667-3307 

Minnesota
      Rochester,  Minnesota,  55905,  United States; Not yet recruiting
Study Coordinator  507-284-5689 

Ohio
      Cincinnati,  Ohio,  45229,  United States; Not yet recruiting
Study Coordinator  513-636-1317 

Tennessee
      Nashville,  Tennessee,  37203,  United States; Not yet recruiting
Study Coordinator  615-936-5723 

Utah
      Salt Lake City,  Utah,  84132,  United States; Not yet recruiting
Study Coordinator  801-581-6465 

Virginia
      Richmond,  Virginia,  23298,  United States; Not yet recruiting
Study Coordinator  202-257-9066 

Wisconsin
      Madison,  Wisconsin,  53792,  United States; Not yet recruiting
Study Coordinator  608-262-2804 

Canada, Alberta
      Edmonton,  Alberta,  T6G 1Z2,  Canada; Not yet recruiting
Study Coordinator  1-780-432-8791 

Canada, Manitoba
      Winnipeg,  Manitoba,  R3C 0N2,  Canada; Not yet recruiting
Study Coordinator  1-204-957-3390 

Canada, Nova Scotia
      Halifax,  Nova Scotia,  B3H 1V7,  Canada; Not yet recruiting
Study Coordinator  1-902-473-1399 

Canada, Ontario
      Hamilton,  Ontario,  L8N 3Z5,  Canada; Not yet recruiting
Study Coordinator  1-905-525-9140  Ext. 22939 

      Toronto,  Ontario,  M5T 3A9,  Canada; Recruiting
Study Coordinator  1-416-963-9338  Ext. 338 

Canada, Quebec
      Montreal,  Quebec,  H3A 1A1,  Canada; Not yet recruiting
Study Coordinator  1-514-842-1231  Ext. 34648 

More Information

Study ID Numbers:  100901
Record last reviewed:  November 2004
Last Updated:  November 29, 2004
Record first received:  November 22, 2004
ClinicalTrials.gov Identifier:  NCT00097370
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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November 25, 2009



Page Updated: September 6, 2005
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