Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-26 @ 2:49 PM
Study NCT ID:
NCT00927992
Status:
COMPLETED
Last Update Posted:
2013-01-30
First Post:
2009-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Liver Transplantation in Haemophilia Patients in Spain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}, {'id': 'D002836', 'term': 'Hemophilia B'}], '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': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': "No outcomes were specified in the study protocol. Designation of outcomes as primary and secondary was based on study team's input as study neither specifies nor prioritizes the outcomes."}}, 'adverseEventsModule': {'description': 'There were no adverse events collected in this retrospective study.', 'eventGroups': [{'id': 'EG000', 'title': 'Hemophiliac Participants With Liver Transplant', 'description': 'Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemophiliac Participants With Liver Transplant', 'description': 'Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.'}], 'classes': [{'title': 'Cyclosporine', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Tacrolimus', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Mycophenolate Mofetil', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Everolimus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post liver transplantation up to Month 3', 'description': 'Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all the participants who met the eligibility criteria.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Acute Rejection of Liver Transplant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemophiliac Participants With Liver Transplant', 'description': 'Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post liver transplantation up to Month 3', 'description': 'Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all the participants who met the eligibility criteria.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemophiliac Participants With Liver Transplant', 'description': 'Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post liver transplantation up to Month 3', 'description': 'Number of participants who had liver transplantation after cirrhosis due to hepatitis C virus (HCV) infection and experienced recurrence of HCV infection post liver transplantation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all the participants who met the eligibility criteria.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Survived After Liver Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemophiliac Participants With Liver Transplant', 'description': 'Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Post liver transplantation up to Month 3', 'description': 'Number of participants who survived after liver transplantation was reported. The death reported was a result of acute-related transplantation complications and end-stage liver disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all the participants who met the eligibility criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemophiliac Participants With Liver Transplant', 'description': 'Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.'}], 'classes': [{'title': 'Bolus', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Continuous infusion', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 5 post liver transplantation', 'description': 'Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all the participants who met the eligibility criteria.'}, {'type': 'SECONDARY', 'title': 'Dose of Exogenous Clotting Factors Used During Liver Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemophiliac Participants With Liver Transplant', 'description': 'Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.88', 'spread': '30.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Day 5 post liver transplantation', 'description': 'Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.', 'unitOfMeasure': 'International Unit/kilogram (IU/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable population included all the participants who met the eligibility criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hemophiliac Participants With Liver Transplant', 'description': 'Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.'}], 'timeFrame': 'Post liver transplantation up to Month 3', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not analyzed as only hemophiliac participants were enrolled in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hemophiliac Participants With Liver Transplant', 'description': 'Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hemophiliac Participants With Liver Transplant', 'description': 'Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.45', 'spread': '15.38', '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': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of participants with Type A and B Hemophilia', 'classes': [{'title': 'Type A', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Type B', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-20', 'studyFirstSubmitDate': '2009-06-24', 'resultsFirstSubmitDate': '2012-12-20', 'studyFirstSubmitQcDate': '2009-06-24', 'lastUpdatePostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-20', 'studyFirstPostDateStruct': {'date': '2009-06-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Requiring Immunosuppressive Therapy After Liver Transplantation', 'timeFrame': 'Post liver transplantation up to Month 3', 'description': 'Cyclosporine, corticosteroids, tacrolimus, mycophenolate mofetil, everolimus were considered as immunosuppressive therapy after liver transplantation.'}, {'measure': 'Number of Participants With Acute Rejection of Liver Transplant', 'timeFrame': 'Post liver transplantation up to Month 3', 'description': 'Any acute rejection of the liver transplant was clinically suspected and biopsy proven by central pathologist.'}, {'measure': 'Number of Participants With Hepatitis C Viral Infection Recurrence After Liver Transplantation', 'timeFrame': 'Post liver transplantation up to Month 3', 'description': 'Number of participants who had liver transplantation after cirrhosis due to hepatitis C virus (HCV) infection and experienced recurrence of HCV infection post liver transplantation.'}, {'measure': 'Number of Participants Who Survived After Liver Transplantation', 'timeFrame': 'Post liver transplantation up to Month 3', 'description': 'Number of participants who survived after liver transplantation was reported. The death reported was a result of acute-related transplantation complications and end-stage liver disease.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Requiring Exogenous Clotting Factor Infusion During Liver Transplantation', 'timeFrame': 'Up to Day 5 post liver transplantation', 'description': 'Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.'}, {'measure': 'Dose of Exogenous Clotting Factors Used During Liver Transplantation', 'timeFrame': 'Up to Day 5 post liver transplantation', 'description': 'Exogenous clotting factors administered post liver transplant included Prothromplex; platelets, fibrinogen and fresh frozen plasma (FFP) combination; FFP and platelets combination. Clotting factors were administered either as bolus or as continuous infusion.'}, {'measure': 'Number of Participants With and Without Hemophilia Requiring Immunosuppressive Therapy, Had Acute Rejection, Hepatitis C Viral Infection Recurrence and Who Survived After Liver Transplantation', 'timeFrame': 'Post liver transplantation up to Month 3'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemophilia', 'Hemophilia B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3082B1-4436&StudyName=Study%20Evaluating%20Liver%20Transplantation%20in%20Haemophilia%20Patients%20in%20Spain%20%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will analyze survival and outcome of patients with severe haemophilia who undergo liver transplantation in Spain', 'detailedDescription': 'Probability Sample'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with haemophilia who underwent liver transplantation and who have been followed-up at any site in Spain.\n\nExclusion Criteria:\n\n* Patients without informed consent form.'}, 'identificationModule': {'nctId': 'NCT00927992', 'briefTitle': 'Study Evaluating Liver Transplantation in Haemophilia Patients in Spain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'Liver Transplantation in Haemophilia Patients in Spain', 'orgStudyIdInfo': {'id': 'B1831011'}, 'secondaryIdInfos': [{'id': '3082B1-4436', 'type': 'OTHER', 'domain': 'Wyeth'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with haemophilia who undergo liver transplantation', 'description': 'Patients with haemophilia who underwent liver transplantation and who have been followed up at any site in Spain.', 'interventionNames': ['Other: Epidemiological Non interventional']}], 'interventions': [{'name': 'Epidemiological Non interventional', 'type': 'OTHER', 'description': 'Epidemiological Non interventional', 'armGroupLabels': ['Patients with haemophilia who undergo liver transplantation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}