Open Label Study of GSK2402968 in Subjects With Duchenne Muscular Dystrophy
NCT ID: NCT01480245
Last Updated: 2017-03-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
233 participants
INTERVENTIONAL
2011-09-30
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Continuous Dosing
GSK2402968 6mg/kg/week
GSK2402968
6mg/kg/week
Intermittent Dosing
GSK2402968 6mg/kg/week
GSK2402968
6mg/kg/week
Natural History Observation
The objective of this arm will be to explore DMD disease progression in a naturalistic setting once discontinuing active treatment
No interventions assigned to this group
Interventions
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GSK2402968
6mg/kg/week
Eligibility Criteria
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Inclusion Criteria
* Continued use of glucocorticoids
* Willing and able to comply with all protocol requirements
* Able to give informed consent
* French subjects: Eligible for inclusion only if either affiliated to or a beneficiary of a social security category.
Exclusion Criteria
* Use of anticoagulants, antithrombotics or antiplatelet agents, previous treatment with investigational drugs,except GSK2402968, within 1 month of the first administration of study medication,
* Current or anticipated participation in any investigational clinical studies,
* History of significant medical disorder which may confound the interpretation of either efficacy or safety data e.g. current history of renal or liver disease/impairment, history of inflammatory disease.
5 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
GSK Investigational Site
Westmead, New South Wales, Australia
GSK Investigational Site
Parkville, Victoria, Australia
GSK Investigational Site
Ghent, , Belgium
GSK Investigational Site
Leuven, , Belgium
GSK Investigational Site
Curitiba, Paraná, Brazil
GSK Investigational Site
Rio de Janeiro, Rio de Janeiro, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, Brazil
GSK Investigational Site
Ribeirão Preto, São Paulo, Brazil
GSK Investigational Site
Santo André, São Paulo, Brazil
GSK Investigational Site
São Paulo, São Paulo, Brazil
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
London, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Temuco, Región de La Araucania, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, Chile
GSK Investigational Site
Santiago, , Chile
GSK Investigational Site
Brno, , Czechia
GSK Investigational Site
Prague, , Czechia
GSK Investigational Site
Koebenhavn Oe, , Denmark
GSK Investigational Site
Bordeaux, , France
GSK Investigational Site
Lille, , France
GSK Investigational Site
Marseille, , France
GSK Investigational Site
Montpellier, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Pau, , France
GSK Investigational Site
Toulouse, , France
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Göttingen, Lower Saxony, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, Germany
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany
GSK Investigational Site
Budapest, , Hungary
GSK Investigational Site
Jerusalem, , Israel
GSK Investigational Site
Ferrara, Emilia-Romagna, Italy
GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
Milan, Lombardy, Italy
GSK Investigational Site
Messina, Sicily, Italy
GSK Investigational Site
Hyōgo, , Japan
GSK Investigational Site
Kumamoto, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Leiden, , Netherlands
GSK Investigational Site
Nijmegen, , Netherlands
GSK Investigational Site
Oslo, , Norway
GSK Investigational Site
Warsaw, , Poland
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Esplugues de Llobregat. Barcelona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Kaohsiung City, , Taiwan
GSK Investigational Site
Ankara, , Turkey (Türkiye)
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Newcastle upon Tyne, , United Kingdom
Countries
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Other Identifiers
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114349
Identifier Type: -
Identifier Source: org_study_id
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