Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-04 @ 4:40 PM
Study NCT ID:
NCT01265420
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2010-12-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004387', 'term': 'Dupuytren Contracture'}], 'ancestors': [{'id': 'D005350', 'term': 'Fibroma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003286', 'term': 'Contracture'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003012', 'term': 'Microbial Collagenase'}], 'ancestors': [{'id': 'D017364', 'term': 'Collagenases'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tdk@hand.md', 'phone': '317-875-9105', 'title': 'F. Thomas D. Kaplan', 'organization': 'Indiana Hand to Shoulder Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1 patient was seen at Day 10, but not at day 30. At Day 10, patient met the primary endpoint'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 after injection to Day 30', 'eventGroups': [{'id': 'EG000', 'title': 'Injectable Clostridial Collagenase', 'description': 'Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace', 'otherNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Paresthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Skin Tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Injectable Clostridial Collagenase', 'description': 'Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace'}], 'classes': [{'title': '>50% reduction in contracture', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '<50% reduction in contracture', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after last injection', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Injectable Clostridial Collagenase', 'description': 'Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One patient was seen at Day 10 but did not return for Day 30 evaluation', 'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Injectable Clostridial Collagenase', 'description': 'Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '78'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2010-12-21', 'resultsFirstSubmitDate': '2015-03-28', 'studyFirstSubmitQcDate': '2010-12-22', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-28', 'studyFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number Patients Obtaining Clinical Improvement (>50% Reduction in Contracture)', 'timeFrame': '30 days after last injection'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dupuytren', "Dupuytren's Disease"], 'conditions': ["Dupuytren's Contracture"]}, 'referencesModule': {'references': [{'pmid': '19726771', 'type': 'BACKGROUND', 'citation': "Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866."}]}, 'descriptionModule': {'briefSummary': "This study will evaluate the efficacy and safety of clostridial collagenase injections for treatment of Dupuytren's contracture of the thumb and first web space. The investigators hypothesis is that clostridial collagenase will have safety not significantly different to that demonstrated in Phase III clinical trials, and will be effective in significantly reducing the degree of thumb contracture."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult subjects (\\> 18 years) of either gender with an MP and/or IP joint contracture and a palpable cord of \\> 20 degrees of the thumb\n* First web space contracture with a palpable cord due to Dupuytren's contracture\n\nExclusion Criteria:\n\n* Prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture of the same thumb.\n* Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).\n* Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.\n* Any subject with known allergy to Xiaflex (Clostridial collagenase).\n* Pregnant or nursing female\n* Any subject who cannot conform to the study visit schedule"}, 'identificationModule': {'nctId': 'NCT01265420', 'briefTitle': "Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb", 'organization': {'class': 'OTHER', 'fullName': 'Indiana Hand to Shoulder Center'}, 'officialTitle': "The Efficacy and Safety of Xiaflex Injections for the Treatment of Thumb Cords in Dupuytren's Contractures", 'orgStudyIdInfo': {'id': 'IHtSC-Thumb 101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injectable clostridial collagenase', 'description': "Patients with thumb 1st web contracture secondary to Dupuytren's disease will be treated with 0.58mg of collagenase", 'interventionNames': ['Biological: Injectable clostridial collagenase']}], 'interventions': [{'name': 'Injectable clostridial collagenase', 'type': 'BIOLOGICAL', 'otherNames': ['Xiaflex'], 'description': "Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections", 'armGroupLabels': ['Injectable clostridial collagenase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46260', 'city': 'Indianaplis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hand to Shoulder Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana Hand to Shoulder Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'F. Thomas D. Kaplan, MD', 'investigatorAffiliation': 'Indiana Hand to Shoulder Center'}}}}