Phase
Condition
Asthma
Treatment
N/AClinical Study ID
Ages > 6 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject participated in GSK-sponsored asthma clinical study with mepolizumab asspecified in Study 200862 and 200363
Subject has either: completed the treatment period in the mepolizumab asthma clinicalstudy to which they were originally enrolled or if the subject was withdrawn fromstudy treatment prematurely during the mepolizumab asthma clinical study to whichthey were originally enrolled but the subject has completed the study assessments atthe study visit that would have been the end of the respective treatment period.
The treating physician requesting mepolizumab under this Long-term Access Programmeconsiders the benefits of treatment with mepolizumab outweigh the risks for theindividual subject.
To be eligible for mepolizumab treatment under this Long-term Access Programme,females of childbearing potential (FCBP) must commit to consistent and correct use ofan acceptable method of birth control, beginning with consent, for the duration ofthe treatment with mepolizumab and for 4 months after the last mepolizumabadministration.
The subject consents to receiving treatment with mepolizumab under this Long-termAccess Programme. In the case of a paediatric subject being eligible aparent(s)/guardian will give written informed consent prior to the child'sparticipation in the study. If applicable, the subject must be able and willing togive assent to take part in the study according to the local requirement.
Exclusion
Exclusion Criteria:
A current malignancy or history of cancer in remission for less than 12 months (Subjects who had localized carcinoma (i.e., basal or squamous cell) of the skinwhich was resected for cure will not be excluded).
Subject has other clinically significant medical conditions uncontrolled withstandard-of-care therapy not associated with asthma, e.g., unstable liver disease,uncontrolled cardiovascular disease, ongoing active infectious disease requiringsystemic treatment.
Subject is pregnant or breastfeeding. Subjects should not be considered for continuedtreatment if they plan to become pregnant during the course of treatment withmepolizumab.
Subject has a known allergy or intolerance to a monoclonal antibody or biologictherapy including mepolizumab.
Subject had an adverse event (serious or non-serious) considered related to studytreatment whilst participating in a clinical study with mepolizumab which resulted inpermanent withdrawal of study treatment.
Subject is receiving treatment with another biological therapy such as a monoclonalantibody therapy or intravenous (IV) immunoglobulin (Ig) therapy.
Subjects who have received treatment with an investigational drug within the past 30days or 5 terminal phase half-lives of the drug whichever is longer, prior toinitiation of mepolizumab treatment under this Long-term Access Programme (this alsoincludes investigational formulations of marketed products).
Subject is currently participating in any other interventional clinical study.
Study Design
Connect with a study center
GSK Investigational Site
La Plata, Buenos Aires 1900
ArgentinaActive - Recruiting
GSK Investigational Site
Mar del Plata, Buenos Aires 7600
ArgentinaActive - Recruiting
GSK Investigational Site
San Rafael, Mendoza 5600
ArgentinaActive - Recruiting
GSK Investigational Site
Rosario, Santa Fe S2000JKR
ArgentinaActive - Recruiting
GSK Investigational Site
Buenos Aires, C1425BEN
ArgentinaActive - Recruiting
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, C1121ABE
ArgentinaActive - Recruiting
GSK Investigational Site
Brussels, 1000
BelgiumCompleted
GSK Investigational Site
Erpent, 5101
BelgiumCompleted
GSK Investigational Site
Gent, 9000
BelgiumCompleted
GSK Investigational Site
Leuven, 3000
BelgiumCompleted
GSK Investigational Site
Liège, 4000
BelgiumCompleted
GSK Investigational Site
Pleven, 5800
BulgariaActive - Recruiting
GSK Investigational Site
Sofia, 1431
BulgariaCompleted
GSK Investigational Site
Calgary, Alberta T2N 4Z6
CanadaCompleted
GSK Investigational Site
Vancouver, British Columbia V5Z 1M9
CanadaCompleted
GSK Investigational Site
Windsor, Ontario N8X 5A6
CanadaCompleted
GSK Investigational Site
Montreal, Quebec H4J 1C5
CanadaCompleted
GSK Investigational Site
Sainte-Foy, Quebec G1V 4G5
CanadaCompleted
GSK Investigational Site
St-Charles-Borromée, Quebec J6E 2B4
CanadaCompleted
GSK Investigational Site
Hlucin, 748 01
Czech RepublicActive - Recruiting
GSK Investigational Site
Hradec Kralove, 500 05
Czech RepublicActive - Recruiting
GSK Investigational Site
Kralupy nad Vltavou, 278 01
Czech RepublicActive - Recruiting
GSK Investigational Site
Olomouc, 775 20
Czech RepublicActive - Recruiting
GSK Investigational Site
Plzen, 305 99
Czech RepublicActive - Recruiting
GSK Investigational Site
Tallinn, 13419
EstoniaActive - Recruiting
GSK Investigational Site
Tartu, 51014
EstoniaCompleted
GSK Investigational Site
Brest Cedex, 29609
FranceActive - Recruiting
GSK Investigational Site
Dijon Cedex, 21033
FranceActive - Recruiting
GSK Investigational Site
Lille cedex, 59037
FranceActive - Recruiting
GSK Investigational Site
Lyon cedex 04, 69317
FranceActive - Recruiting
GSK Investigational Site
Marseille Cedex 20, 13915
FranceActive - Recruiting
GSK Investigational Site
Montpellier cedex 5, 34295
FranceActive - Recruiting
GSK Investigational Site
Nantes cedex 1, 44093
FranceActive - Recruiting
GSK Investigational Site
Paris Cedex 18, 75877
FranceActive - Recruiting
GSK Investigational Site
Pessac cedex, 33604
FranceActive - Recruiting
GSK Investigational Site
Reims Cedex, 51092
FranceActive - Recruiting
GSK Investigational Site
Bamberg, Bayern 96049
GermanyCompleted
GSK Investigational Site
Koblenz, Rheinland-Pfalz 56068
GermanyCompleted
GSK Investigational Site
Leipzig, Sachsen 04357
GermanyCompleted
GSK Investigational Site
Schleswig, Schleswig-Holstein 24837
GermanyCompleted
GSK Investigational Site
Berlin, 12203
GermanyCompleted
GSK Investigational Site
Hamburg, 22299
GermanyTerminated
GSK Investigational Site
Athens, 106 76
GreeceActive - Recruiting
GSK Investigational Site
Haidari / Athens, 124 62
GreeceActive - Recruiting
GSK Investigational Site
Thessaloniki, 56403
GreeceActive - Recruiting
GSK Investigational Site
Parma, Emilia-Romagna 43125
ItalyActive - Recruiting
GSK Investigational Site
Bari, Puglia 70124
ItalyActive - Recruiting
GSK Investigational Site
Foggia, Puglia 71100
ItalyActive - Recruiting
GSK Investigational Site
Firenze, Toscana 50134
ItalyActive - Recruiting
GSK Investigational Site
Amsterdam, 1105 AZ
NetherlandsCompleted
GSK Investigational Site
Breda, 4818 CK
NetherlandsCompleted
GSK Investigational Site
Leeuwarden, 8934 AD
NetherlandsCompleted
GSK Investigational Site
Leiden, 2333 ZA
NetherlandsCompleted
GSK Investigational Site
Rotterdam, 3045 PM
NetherlandsCompleted
GSK Investigational Site
Bergen, 5021
NorwayActive - Recruiting
GSK Investigational Site
Lima 27, Lima Lima 27
PeruActive - Recruiting
GSK Investigational Site
San Martin de Porres, Lima Lima 31
PeruActive - Recruiting
GSK Investigational Site
San Miguel, Lima Lima 32
PeruActive - Recruiting
GSK Investigational Site
Lima, Lima 1
PeruActive - Recruiting
GSK Investigational Site
Ekaterinburg, 620 109
Russian FederationActive - Recruiting
GSK Investigational Site
Irkutsk, 664043
Russian FederationActive - Recruiting
GSK Investigational Site
Moscow, 115409
Russian FederationActive - Recruiting
GSK Investigational Site
Novosibirsk, 630102
Russian FederationActive - Recruiting
GSK Investigational Site
Saint Petesburg, 195030
Russian FederationCompleted
GSK Investigational Site
St'Petersburg, 197706
Russian FederationActive - Recruiting
GSK Investigational Site
St. Petersburg, 198216
Russian FederationActive - Recruiting
GSK Investigational Site
Stavropol, 355017
Russian FederationActive - Recruiting
GSK Investigational Site
Voronezh, 394066
Russian FederationActive - Recruiting
GSK Investigational Site
Sala, 927 01
SlovakiaActive - Recruiting
GSK Investigational Site
Spisska Nova Ves, 052 01
SlovakiaActive - Recruiting
GSK Investigational Site
Vrable, 952 01
SlovakiaCompleted
GSK Investigational Site
Alcorcón (Madrid), 28922
SpainCompleted
GSK Investigational Site
Madrid, 28041
SpainCompleted
GSK Investigational Site
Pozuelo de Alarcón/Madrid, 28223
SpainCompleted
GSK Investigational Site
Santander, 39008
SpainCompleted
GSK Investigational Site
Santiago de Compostela. La Coruña., 15706
SpainCompleted
GSK Investigational Site
Valencia, 46026
SpainCompleted
GSK Investigational Site
Dnipropetrovsk, 49051
UkraineActive - Recruiting
GSK Investigational Site
Kharkiv, 61124
UkraineActive - Recruiting
GSK Investigational Site
Kyiv, 03680
UkraineActive - Recruiting
GSK Investigational Site
Vinnytsia, 21029
UkraineActive - Recruiting
GSK Investigational Site
Bradford, BD96RJ
United KingdomActive - Recruiting
GSK Investigational Site
Oxford, OX37LE
United KingdomActive - Recruiting
GSK Investigational Site
Plymouth, PL6 8DH
United KingdomActive - Recruiting
GSK Investigational Site
Swansea, SA2 8PP
United KingdomActive - Recruiting
GSK Investigational Site
Rolling Hills Estates, California 90274
United StatesCompleted
GSK Investigational Site
Baltimore, Maryland 21236
United StatesCompleted
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