Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
NCT ID: NCT01239758
Last Updated: 2013-02-01
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
PHASE2
11 participants
INTERVENTIONAL
2010-10-31
2011-05-31
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
PARALLEL
TREATMENT
NONE
Study Groups
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ACE-031 (Extension of cohort 1 from core study, A031-03)
ACE-031 (Extension of cohort 1 from core study, A031-03)
ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 24 weeks.
ACE-031 (Extension of cohort 2 from core study, A031-03)
ACE-031 (Extension of cohort 2 from core study, A031-03)
Up to 1.0 mg/kg subcutaneously once every 2 weeks for 24 weeks.
ACE-031 (Extension of cohort 3 from core study, A031-03)
ACE-031 (Extension of cohort 3 from core study, A031-03)
Up to 2.5 mg/kg subcutaneously once every 4 weeks for 24 weeks.
Interventions
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ACE-031 (Extension of cohort 1 from core study, A031-03)
ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 24 weeks.
ACE-031 (Extension of cohort 2 from core study, A031-03)
Up to 1.0 mg/kg subcutaneously once every 2 weeks for 24 weeks.
ACE-031 (Extension of cohort 3 from core study, A031-03)
Up to 2.5 mg/kg subcutaneously once every 4 weeks for 24 weeks.
Eligibility Criteria
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Inclusion Criteria
* Continuation of corticosteroid therapy at the same absolute dose and schedule as on Study A031-03
Exclusion Criteria
* Plans to have surgery during the course of the study
4 Years
MALE
No
Sponsors
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Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA
INDUSTRY
Responsible Party
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Locations
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Acceleron Investigative Site
Calgary, Alberta, Canada
Acceleron Investigative Site
Hamilton, Ontario, Canada
Acceleron Investigative Site
London, Ontario, Canada
Acceleron Investigative Site
Ottawa, Ontario, Canada
Countries
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Other Identifiers
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A031-06
Identifier Type: -
Identifier Source: org_study_id
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