Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01239758
Status:
TERMINATED
Last Update Posted:
2013-02-01
First Post:
2010-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'This study was terminated based on preliminary safety data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2013-01-24', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-30', 'studyFirstSubmitDate': '2010-11-01', 'dispFirstSubmitQcDate': '2013-01-30', 'studyFirstSubmitQcDate': '2010-11-10', 'dispFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with adverse events.', 'timeFrame': 'From treatment initiation to End-of-Study Visit, approximately 24 weeks later.'}, {'measure': 'Change in laboratory parameters and vital signs.', 'timeFrame': 'Baseline to End-of-Study Visit, approximately 24 weeks later.'}], 'secondaryOutcomes': [{'measure': 'Percent change in total lean body mass by DXA scan.', 'timeFrame': 'Baseline to End-of-Study Visit, approximately 24 weeks later.'}, {'measure': 'Percent change in total body and lumbar spine bone mineral density by DXA scan.', 'timeFrame': 'Baseline to End-of-Study Visit, approximately 24 weeks later.'}, {'measure': 'Percent change in muscle strength score by hand-held myometry.', 'timeFrame': 'Baseline to End-of-Study Visit, approximately 24 weeks later.'}, {'measure': 'Change in distance traveled in 6 minutes (standardized 6-Minute-Walk Test).', 'timeFrame': 'Baseline to End-of-Study Visit, approximately 24 weeks later.'}, {'measure': 'Change in time to travel 10 meters (standardized 10-Meter-Walk/Run test).', 'timeFrame': 'Baseline to End-of-Study Visit, approximately 24 weeks later.'}, {'measure': 'Change in pulmonary function tests.', 'timeFrame': 'Baseline to End-of-Study Visit, approximately 24 weeks later.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Duchenne Muscular Dystrophy']}, 'descriptionModule': {'briefSummary': 'To evaluate the long-term safety and tolerability of ACE-031 administration in subjects with Duchenne muscular dystrophy (DMD) who participated in Study A031-03. \\[Note: This study was terminated based on preliminary safety data. Pending further analysis of safety data and discussion with health authorities, a new ACE-031 trial will be planned.\\]'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of participation in Study A031-03 and Investigator approval\n* Continuation of corticosteroid therapy at the same absolute dose and schedule as on Study A031-03\n\nExclusion Criteria:\n\n* Participation in any other therapeutic clinical trial\n* Plans to have surgery during the course of the study'}, 'identificationModule': {'nctId': 'NCT01239758', 'briefTitle': 'Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA'}, 'officialTitle': 'An Open-Label Extension Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of ACE-031 (ActRIIB-IgG1) in Subjects With Duchenne Muscular Dystrophy', 'orgStudyIdInfo': {'id': 'A031-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACE-031 (Extension of cohort 1 from core study, A031-03)', 'interventionNames': ['Biological: ACE-031 (Extension of cohort 1 from core study, A031-03)']}, {'type': 'EXPERIMENTAL', 'label': 'ACE-031 (Extension of cohort 2 from core study, A031-03)', 'interventionNames': ['Biological: ACE-031 (Extension of cohort 2 from core study, A031-03)']}, {'type': 'EXPERIMENTAL', 'label': 'ACE-031 (Extension of cohort 3 from core study, A031-03)', 'interventionNames': ['Biological: ACE-031 (Extension of cohort 3 from core study, A031-03)']}], 'interventions': [{'name': 'ACE-031 (Extension of cohort 1 from core study, A031-03)', 'type': 'BIOLOGICAL', 'description': 'ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 24 weeks.', 'armGroupLabels': ['ACE-031 (Extension of cohort 1 from core study, A031-03)']}, {'name': 'ACE-031 (Extension of cohort 2 from core study, A031-03)', 'type': 'BIOLOGICAL', 'description': 'Up to 1.0 mg/kg subcutaneously once every 2 weeks for 24 weeks.', 'armGroupLabels': ['ACE-031 (Extension of cohort 2 from core study, A031-03)']}, {'name': 'ACE-031 (Extension of cohort 3 from core study, A031-03)', 'type': 'BIOLOGICAL', 'description': 'Up to 2.5 mg/kg subcutaneously once every 4 weeks for 24 weeks.', 'armGroupLabels': ['ACE-031 (Extension of cohort 3 from core study, A031-03)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Acceleron Investigative Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Acceleron Investigative Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Acceleron Investigative Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Acceleron Investigative Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}