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This Record Contains Information About the Mepolizumab Compassionate Use (CU) Product Activities: 104317: CU and Long-Term Access Study of Mepolizumab in HES. 201956:A Long-term Access Programme for Subjects With Severe Asthma 112562: Expanded Access for Patients With Hypereosinophilic

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ClinicalTrials.gov Identifier: NCT00244686
Expanded Access Status : Available
First Posted : October 27, 2005
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date October 25, 2005
First Posted Date October 27, 2005
Last Update Posted Date January 13, 2020
 
Descriptive Information
Brief Title This Record Contains Information About the Mepolizumab Compassionate Use (CU) Product Activities: 104317: CU and Long-Term Access Study of Mepolizumab in HES. 201956:A Long-term Access Programme for Subjects With Severe Asthma 112562: Expanded Access for Patients With Hypereosinophilic
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for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application.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.

112562: To provide a mechanism for expanded access to mepolizumab therapy for eligible patients with HES. Whenever possible, use of an investigational medicinal product by a patient as part of a clinical trial is preferable. However, when patient enrollment in a clinical trial is not possible (such as when the patient is not eligible for ongoing clinical trials or the patient is not able to attend investigational sites), appropriate patients may receive mepolizumab through expanded access. This expanded access protocol was designed to allow access to mepolizumab for HES patients with seriously debilitating or life-threatening disease that are not able to enroll in clinical trials, including those patients that have already participated in a mepolizumab clinical trial.

Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Treatment IND/Protocol
Intervention Drug: Mepolizumab
open label investigational product
Publications * Kuang FL, Fay MP, Ware J, Wetzler L, Holland-Thomas N, Brown T, Ortega H, Steinfeld J, Khoury P, Klion AD. Long-Term Clinical Outcomes of High-Dose Mepolizumab Treatment for Hypereosinophilic Syndrome. J Allergy Clin Immunol Pract. 2018 Sep - Oct;6(5):1518-1527.e5. doi: 10.1016/j.jaip.2018.04.033. Epub 2018 May 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Expanded Access Status Available
Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center +44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com
Listed Location Countries Not Provided
Removed Location Countries Australia,   Belgium,   Canada,   France,   Germany,   Italy,   Netherlands,   Norway,   Portugal,   Spain,   Switzerland,   Thailand,   United Kingdom,   United States
 
Administrative Information
NCT Number NCT00244686
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date January 2020