Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244686
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2020-11-25
First Post:
2005-10-25
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 201956A Long-term Access Programme for Subjects With Severe Asthma 112562 Expanded Access for Patients With Hypereosinophilic
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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for mepolizumab for the indication of hypereosinophilic syndrome HES was filed in 2008 but later the file was withdrawn due to outstanding questions from regulators raised from the application On the basis of sponsors evaluation participants with life-threatening HES who have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 subjects 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
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 subjects 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-000838-39 | EUDRACT_NUMBER | None | None |