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Sponsors and Collaborators: |
Brigham and Women's Hospital GlaxoSmithKline |
Information provided by: | Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT00527566 |
The purpose of this study is to determine whether Mepolizumab (a monoclonal antibody against interleukin-5) is a safe and well-tolerated therapy that will allow for steroid tapering in patients with steroid-dependent Churg-Strauss Syndrome (CSS).
Condition | Intervention | Phase |
Churg Strauss Syndrome |
Biological: Mepolizumab |
Phase I Phase II |
ChemIDplus related topics: | Mepolizumab |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Mepolizumab As a Steroid Sparing Treatment Option in the Churg Strauss Syndrome |
Estimated Enrollment: | 10 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Single arm: Experimental
Subjects will receive open-label mepolizumab
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Biological: Mepolizumab
IV mepolizumab, 750 mg
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Specific Aims:
Demonstrate the efficacy of anti-IL5 therapy in improving the signs and symptoms of CSS by:
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael E Wechsler, MD. MMSc | 617-732-8202 | mwechsler@partners.org |
Contact: Sophia Kim, MD | 617-525-3218 | skim48@partners.org |
United States, Massachusetts | |||||
Brigham and Women's Hospital | Recruiting | ||||
Boston, Massachusetts, United States, 02115 | |||||
Principal Investigator: Michael Wechsler, MD |
Brigham and Women's Hospital |
GlaxoSmithKline |
Principal Investigator: | Michael Wechsler, MD | Brigham and Women's Hospital |
Responsible Party: | Brigham and Women's Hospital ( Michael E. Wechsler, MD ) |
Study ID Numbers: | 2007-P-000012/1;BWH |
First Received: | September 7, 2007 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00527566 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
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