Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT00396318
Status:
COMPLETED
Last Update Posted:
2011-04-27
First Post:
2006-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077785', 'term': 'Tenecteplase'}], 'ancestors': [{'id': 'D010959', 'term': 'Tissue Plasminogen Activator'}, {'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D010960', 'term': 'Plasminogen Activators'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Genentech, Inc.'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.', 'description': 'Modified intent to treat (MITT) population.\n\nNote: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.', 'eventGroups': [{'id': 'EG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.', 'otherNumAtRisk': 246, 'otherNumAffected': 26, 'seriousNumAtRisk': 246, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Eye Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Eye disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Catheter Related Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Drug Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Graft Versus Host Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Otitis Media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Rash Pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Streptococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Muscle Spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Increased Upper Airway Secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'seriousEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 2}], 'organSystem': 'General disorders'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Immune system disorders'}, {'term': 'Catheter Related Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Device Malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 246, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients Who Had Cumulative Restoration Rates of Central Venous Catheter (CVC) Function Following a Single Administration of Tenecteplase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '66.3', 'upperLimit': '77.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '120 minutes after first dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (MITT) population'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '35.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes after first dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (MITT) population'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '47.0', 'upperLimit': '59.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after first dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (MITT) population'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000', 'lowerLimit': '71.1', 'upperLimit': '81.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes after second dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (MITT) population'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '78.5', 'groupId': 'OG000', 'lowerLimit': '73.3', 'upperLimit': '83.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after second dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (MITT) population'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '86.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '120 minutes after second dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (MITT) population'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.'}], 'classes': [{'title': 'Through first tenecteplase instillation', 'categories': [{'measurements': [{'value': '72.0', 'groupId': 'OG000', 'lowerLimit': '66.3', 'upperLimit': '77.6'}]}]}, {'title': 'Through second tenecteplase instillation', 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '86.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 120 minutes post-treatment (Dose 1 or Dose 2)', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent to treat (MITT) population'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Who Had Cumulative Restoration Rates Restoration Rates of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '74.5', 'upperLimit': '87.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 days post-treatment', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of patients (from MITT population) with restored CVC function during the treatment period'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.'}], 'periods': [{'title': 'At Least One Dose of Tenecteplase (MITT)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Subject withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}, {'title': '48- to 96-Hour Follow-Up Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '246'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}, {'title': '7-Day Post-Treatment Contact', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '240'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Five patients were randomized but not treated, therefore the modified intent to treat (MITT) analysis population was 246.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '246', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tenecteplase', 'description': '2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '26.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 2 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': '≥ 2 to < 17 years', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}]}]}, {'title': '≥ 17 to < 65 years', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '155', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 251}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'dispFirstSubmitDate': '2009-06-10', 'lastUpdateSubmitDate': '2011-03-29', 'studyFirstSubmitDate': '2006-11-02', 'dispFirstSubmitQcDate': '2009-08-07', 'resultsFirstSubmitDate': '2010-09-19', 'studyFirstSubmitQcDate': '2006-11-02', 'dispFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-29', 'studyFirstPostDateStruct': {'date': '2006-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Who Had Cumulative Restoration Rates of Central Venous Catheter (CVC) Function Following a Single Administration of Tenecteplase', 'timeFrame': '120 minutes after first dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase', 'timeFrame': '15 minutes after first dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.'}, {'measure': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase', 'timeFrame': '30 minutes after first dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.'}, {'measure': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase', 'timeFrame': '15 minutes after second dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.'}, {'measure': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase', 'timeFrame': '30 minutes after second dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.'}, {'measure': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase', 'timeFrame': '120 minutes after second dose', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.'}, {'measure': 'Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase', 'timeFrame': 'Up to 120 minutes post-treatment (Dose 1 or Dose 2)', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.'}, {'measure': 'Percentage of Patients Who Had Cumulative Restoration Rates Restoration Rates of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase', 'timeFrame': 'Up to 7 days post-treatment', 'description': 'Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing \\< 10 kg.'}]}, 'conditionsModule': {'keywords': ['TNKase', 'CVA', 'CVAD', 'Central venous access catheter'], 'conditions': ['Dysfunctional Central Venous Access Catheters']}, 'descriptionModule': {'briefSummary': 'This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the United States and Canada. 251 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were enrolled in the study and treated with one or two doses of tenecteplase.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically stable, in the opinion of the investigator\n* CVC occlusion\n* Able to have fluids infused at the volume necessary to instill study drug into the CVC\n\nExclusion Criteria:\n\n* Able to have 3 mL of blood (patients weighing ≥ 10 kg) or 1 mL of blood (patients weighing \\< 10 kg) withdrawn from the selected CVC following patient repositioning\n* Selected study CVC inserted \\< 2 days prior to treatment\n* Selected study CVC implanted specifically for hemodialysis (HD) or internally coated with any therapeutic agent\n* Use of a power injector on the selected study CVC during study drug treatment\n* Evidence of mechanical, non-thrombotic occlusion of the selected study CVC (e.g., kink in the catheter or suture constricting the catheter)\n* Previously treated in this study or any tenecteplase catheter clearance trial\n* Use of any investigational drug or therapy within 28 days prior to treatment\n* Use of a fibrinolytic agent (e.g., alteplase, tenecteplase, reteplase, or urokinase) within 24 hours prior to treatment\n* Known to be pregnant or breastfeeding at screening\n* Known bacteremia or known or suspected infection in the CVC catheter\n* Known history of intracranial hemorrhage (within the previous 3 years), intracranial aneurysm, or arteriovenous malformation\n* Use of heparin (unfractionated or low molecular weight) or any other anticoagulants within 24 hours prior to treatment, except heparin used for prophylaxis or intermittent or low-dose, continuous infusion of heparin to maintain catheter or vessel patency\n* Subjects treated with warfarin only: international normalized ratio (INR) ≥ 3.0 within 7 days prior to Visit 1, or a target INR range that allows for an INR ≥ 3.0\n* Initiation of or increase in dose of Plavix® (clopidogrel bisulfate) within 7 days prior to treatment\n* At high risk for bleeding events or embolic complications (i.e., recent pulmonary embolus, deep vein thrombosis, endarterectomy, or clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constitutes a significant hazard\n* Known hypersensitivity to tenecteplase or any component of the formulation'}, 'identificationModule': {'nctId': 'NCT00396318', 'acronym': 'TROPICS 2', 'briefTitle': 'A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'A Phase III, Open-Label, Single-Arm Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters', 'orgStudyIdInfo': {'id': 'N3699g'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tenecteplase', 'interventionNames': ['Drug: tenecteplase']}], 'interventions': [{'name': 'tenecteplase', 'type': 'DRUG', 'description': '2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.\n\nPatients weighing ≥ 30 kg received 2-mL instillations of tenecteplase (i.e., 2 mg of tenecteplase). Patients weighing \\< 30 kg received instillations of tenecteplase equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).', 'armGroupLabels': ['Tenecteplase']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Barbara Gillespie, M.D., FASN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Quintiles, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Trials Posting Group', 'oldOrganization': 'Genentech, Inc.'}}}}