Clinical Trial: 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
Study Status: Available
Recruit Status: Available
Study Type: Expanded Access: Available for Individual Patients
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-t
Brief Summary:
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for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application.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 Summary:
Sponsor: GlaxoSmithKline
Current Primary Outcome:
Original Primary Outcome: Incidence and severity of adverse events
Current Secondary Outcome:
Original Secondary Outcome:
- Change in end organ assessments; peripheral blood eosinophil levels; disease control; and HES medications.
- Assessment of mepolizumab dosing requirements as measured by time between doses.
Information By: GlaxoSmithKline
Dates:
Date Received: October 25, 2005
Date Started:
Date Completion:
Last Updated: May 1, 2017
Last Verified: May 2017
