Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT02831660
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2016-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CU Programme of Idarucizumab for Japanese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594745', 'term': 'idarucizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Because of the trial design and backgrounds, only 1 patient was entered in the trial. Because of the limited number of patients, it was difficult to draw general conclusion regarding safety or tolerability of idarucizumab'}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 5 days after last drug administration, up to 6 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Idarucizumab 5 g', 'description': 'The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.', 'otherNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Drug-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Idarucizumab 5 g', 'description': 'The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from first drug administration until 5 days after last drug administration, up to 6 days.', 'description': 'Percentage of subjects with drug-related adverse events is presented', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Idarucizumab 5 g', 'description': 'The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Idarucizumab 5 g', 'description': 'The total dose of 5 g (two 2.5 g vials) was administered intravenously. A single vial contained 2.5 g of idarucizumab (in buffered solution for injection). Patients received a 2.5 g vial of study medication and a second 2.5 g vial within the next 15 minutes. In rare instances, an additional 5 g dose was to be justified.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS) comprised all patients who had been received at least 1 dose of the study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-19', 'studyFirstSubmitDate': '2016-07-11', 'resultsFirstSubmitDate': '2017-08-18', 'studyFirstSubmitQcDate': '2016-07-11', 'lastUpdatePostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-19', 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Drug-related Adverse Events', 'timeFrame': 'from first drug administration until 5 days after last drug administration, up to 6 days.', 'description': 'Percentage of subjects with drug-related adverse events is presented'}]}, 'conditionsModule': {'conditions': ['Hemorrhage']}, 'descriptionModule': {'briefSummary': 'The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrolled or life-threatening bleeding or when emergency surgery or urgent procedures are required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Currently taking dabigatran etexilate.\n* Age \\>= 20 years at entry.\n* Written Informed consent\n* Group A:\n\n \\-- Uncontrolled or life-threatening judged by the physician to require a reversal agent.\n* Group B:\n\n * A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.\n\nExclusion criteria:\n\n* Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).\n* Group A:\n\n * Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care.\n * Patients with no clinical signs of bleeding.\n* Group B:\n\n * surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.'}, 'identificationModule': {'nctId': 'NCT02831660', 'briefTitle': 'CU Programme of Idarucizumab for Japanese Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Compassionate Use Program of Idarucizumab for Reversal of the Anticoagulant Effects of Dabigatran in Japanese Patients Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures', 'orgStudyIdInfo': {'id': '1321.14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'idarucizumab', 'interventionNames': ['Drug: idarucizumab']}], 'interventions': [{'name': 'idarucizumab', 'type': 'DRUG', 'armGroupLabels': ['idarucizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '816-0864', 'city': 'Fukuoka, Kasuga', 'country': 'Japan', 'facility': 'Fukuoka Tokushukai Medical Center'}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}