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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00097370 |
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.
Condition | Intervention | Phase |
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Hypereosinophilia Hypereosinophilic Syndrome |
Drug: mepolizumab |
Phase III |
Study Type: | Interventional |
Study Design: | Open Label, Safety/Efficacy Study, Single Group Assignment, Treatment |
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 |
Estimated Enrollment: | 85 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Or 2). 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 three months after the last dose:Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for the female subjects; Implants of levonorgestrel;Injectable progestogen;Any intrauterine device (IUD) with a documented failure rate of less than 1% per year; Oral contraceptives (either combined or progestogen only)
Exclusion criteria:
Study Director: | GSK Clinical Trials, MB,BS; PhD; FRCP | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 100901 |
Study First Received: | November 22, 2004 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00097370 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anti-IL-5 Hypereosinophilia Hypereosinophilic Syndrome Mepolizumab Open-label |
Hematologic Diseases Hypereosinophilic Syndrome Idiopathic Hypereosinophilic Syndrome Leukocyte Disorders Eosinophilia |
Pathologic Processes Disease Hematologic Diseases Hypereosinophilic Syndrome |
Syndrome Leukocyte Disorders Eosinophilia |