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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00244686|
Expanded Access Status : Available
First Posted : October 27, 2005
Last Update Posted : January 13, 2020
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for mepolizumab for the indication of hypereosinophilic syndrome (HES) was filed in 2008, but later the file was withdrawn due to outstanding questions from regulator's raised from the application.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.
|Condition or disease||Intervention/treatment|
|Hypereosinophilic Syndrome||Drug: Mepolizumab|
|Study Type :||Expanded Access|
|Expanded Access Type :||Treatment IND/Protocol|
|See clinical trials of the intervention/treatment in this expanded access record.|
|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. 112562: Expanded Access to Mepolizumab for Patients With Hypereosinophilic Syndrome|
- Drug: Mepolizumab
open label investigational product
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|
|Contact: EU GSK Clinical Trials Call Center||+44 (0) 20 89904466||GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|