Open-Label Extension Of Intravenous Mepolizumab In Patients With Hypereosinophilic Syndrome
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypereosinophilic Syndrome; Hypereosinophilia
Intervention: mepolizumab (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trial, MB,BS; PhD; FRCP, Study Director, Affiliation: GlaxoSmithKline
Summary
This is an open label study of mepolizumab 750 mg intravenous in those subjects who
participated in study 100185 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.
Clinical Details
Official title: An Open-Label Extension Study to Study MHE100185, to Evaluate Long-Term Safety, Efficacy and Optimal Dosing Frequency of 750 mg Intravenous Mepolizumab in Subjects With Hypereosinophilic Syndromes
Study design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Frequency of all Adverse Events
Secondary outcome: Describe maintenance of durable effect on prednisone dose levelDescribe durable effect in reducing blood eosinophil count Optimal dosing frequency of mepolizumab Quality of life measures
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
Participation in study 100185
Exclusion criteria:
Significantly abnormal laboratory values
Abnormal cardiac function - angina, MI (myocardial infarction).
Pregnancy or nursing.
Locations and Contacts
GSK Clinical Trials Call Center, Edmonton, Alberta T6G 1Z2, Canada
GSK Clinical Trials Call Center, San Diego, California 92103, United States
GSK Clinical Trials Call Center, Denver, Colorado 80206, United States
GSK Clinical Trials Call Center, Winnipeg, Manitoba R3C 0N2, Canada
GSK Clinical Trials Call Center, Bethesda, Maryland 20892, United States
GSK Clinical Trials Call Center, Boston, Massachusetts 02215, United States
GSK Clinical Trials Call Center, Rochester, Minnesota 55905, United States
GSK Clinical Trials Call Center, Halifax, Nova Scotia B3H 1V7, Canada
GSK Clinical Trials Call Center, Cincinnati, Ohio 45229, United States
GSK Clinical Trials Call Center, Toronto, Ontario M5T 3A9, Canada
GSK Clinical Trials Call Center, Hamilton, Ontario L8N 3Z5, Canada
GSK Clinical Trials Call Center, Montreal, Quebec H3A 1A1, Canada
GSK Clinical Trials Call Center, Nashville, Tennessee 37203, United States
GSK Clinical Trials Call Center, Salt Lake City, Utah 84132, United States
GSK Clinical Trials Call Center, Richmond, Virginia 23298, United States
GSK Clinical Trials Call Center, Madison, Wisconsin 53792, United States
Additional Information
Starting date: September 2004
Last updated: September 27, 2006
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