Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT00161720
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Study to Capture Dosing and Treatment Outcome Data in Participants With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020151', 'term': 'Protein C Deficiency'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D019851', 'term': 'Thrombophilia'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011486', 'term': 'Protein C'}], 'ancestors': [{'id': 'D004792', 'term': 'Enzyme Precursors'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D019774', 'term': 'Blood Coagulation Factor Inhibitors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2005-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants who Received a Dose of Protein C in Retrospective Study', 'timeFrame': 'Throughout the study period (up to 6 months)', 'description': 'Number of participants who received a dose of Protein C in retrospective study will be reported.'}, {'measure': 'Number of Participants with Prophylactic Treatment Outcome', 'timeFrame': 'Throughout the study period (up to 6 months)', 'description': 'Participants experience any episodes of purpura fulminans (PF), coumarin induced skin necrosis (CISN), or thromboembolic event during prophylactic treatment will be assessed.'}, {'measure': 'Number of Participants with Acute Episode Treatment Outcome', 'timeFrame': 'Throughout the study period (up to 6 months)', 'description': 'Acute episode treatment outcome includes type of episode (PF, CISN, Thromboembolic); Was treatment effective or not effective; Was patient successfully transitioned to anticoagulation following the resolution of the episode will be assessed.'}, {'measure': 'Number of Participants with Adverse Experiences (AEs) Related to Protein C Concentrate Treatment', 'timeFrame': 'Throughout the study period (up to 6 months)', 'description': 'An AE is defined as any untoward medical occurrence in a participant administered study product that does not necessarily have a casual relationship with the treatment. AEs considered possibly or probably related to Protein C Concentrate treatment will be recorded on case report forms (CRFs).'}]}, 'conditionsModule': {'keywords': ['Severe Congenital Protein C Deficiency'], 'conditions': ['Protein C Deficiency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/5f6b5fc84db2bf003ab460be', 'label': 'To obtain more information on the study, click here/on this link.'}]}, 'descriptionModule': {'briefSummary': 'This is a data collection study with the purpose of capturing dosing and treatment outcome data in participants with severe congenital protein C deficiency who were treated with protein C concentrate under an Emergency Use Investigational New Drug Application (IND).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant treated with protein C concentrate under a Baxter Healthcare Corporation Emergency Use IND.\n* Participant with diagnosis of severe congenital protein C deficiency.\n* Participant or parent/legally authorized representative has provided written informed consent.'}, 'identificationModule': {'nctId': 'NCT00161720', 'briefTitle': 'Retrospective Study to Capture Dosing and Treatment Outcome Data in Participants With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Retrospective Study to Capture Dosing and Treatment Outcome Data in Subjects With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND', 'orgStudyIdInfo': {'id': '400501'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All participants', 'description': 'Participants with severe congenital protein C deficiency who were treated under an emergency use IND.', 'interventionNames': ['Drug: Protein C Concentrate (Human) Vapor Heated']}], 'interventions': [{'name': 'Protein C Concentrate (Human) Vapor Heated', 'type': 'DRUG', 'description': 'Protein C Concentrate (Human) Vapor Heated', 'armGroupLabels': ['All participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Children´s Hospital of Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Children´s Hospital Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80973', 'city': 'Fort Carson', 'state': 'Colorado', 'country': 'United States', 'facility': 'Evans Army Hospital', 'geoPoint': {'lat': 38.73749, 'lon': -104.78886}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Children´s Hospital Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Rainbow Babies & Children´s Hospital', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '45404', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Children´s Medical Center - Dayton', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Cook Children´s Medical Center', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '80218', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Children´s Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxalta now part of Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}