This Record Contains Information About the Mepolizumab Compassionate Use Product Activities: 104317: An Open-Label Compassionate Use and Long-Term Access Study of Mepolizumab in HES. 201956: A Long-term Access Programme for Subjects With Severe Asthma
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|ClinicalTrials.gov Identifier: NCT00244686|
Recruitment Status : Available
First Posted : October 27, 2005
Last Update Posted : September 5, 2017
104317: 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for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application.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.
201956: This is a Long-term Access Programme (LAP) which aims to support provision of mepolizumab, until it is commercially available, to eligible subjects with severe asthma who participated in a GSK-sponsored mepolizumab clinical study in severe asthma. Eligible subjects will initiate mepolizumab within a 6-month period following the individual subject's last scheduled visit in their preceding clinical study. For each subject benefit versus risk will be assessed throughout the study to support continued treatment with mepolizumab.
|Condition or disease||Intervention/treatment|
|Hypereosinophilic Syndrome||Drug: Mepolizumab|
|Study Type :||
|Official Title:||104317: An Open-Label Compassionate Use Access and Long-Term Access Study of Anti IL-5 (Mepolizumab) Treatment in Subjects With Hypereosinophilic Syndrome. 201956: A Long-term Access Programme for Subjects With Severe Asthma Who Participated in a GSK-sponsored Mepolizumab Clinical Study.|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244686
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
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|Study Director:||GSK Clinical Trials||GlaxoSmithKline|