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
|First Submitted Date||October 25, 2005|
|First Posted Date||October 27, 2005|
|Last Update Posted Date||September 5, 2017|
|Brief Title||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|
|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.|
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for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application.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.
|Detailed Description||Not Provided|
|Study Type||Expanded Access|
|Expanded Access Type||Individual Patients|
open label investigational product
|Publications *||Not Provided|
|Expanded Access Status||Available|
104317 Inclusion criteria:
Eosinophilia >1500cells/ul for at least 6 months with evidence of symptoms and signs of organ system involvement or dysfunction that can be directly related to eosinophilia (with no evidence of parasitic, allergic or other recognized causes of eosinophilia such as connective tissues disease, malignancy) or Eosinophilia of >1500cells/ul for less than 6 months who meet the other criteria for HES accompanied by clear evidence of eosinophil tissue infiltration and with exclusion for secondary causes of eosinophilia as above.
104317 Exclusion Criteria:
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 16 weeks after the last dose.
201956 Inclusion criteria:
201956 Exclusion criteria:
|Ages||Child, Adult, Senior|
|Listed Location Countries||Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Switzerland, Thailand, United Kingdom, United States|
|Removed Location Countries|
|Other Study ID Numbers||MHE104317|
|Verification Date||September 2017|