Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-03 @ 9:44 PM
Study NCT ID:
NCT00168051
Status:
WITHDRAWN
Last Update Posted:
2018-09-25
First Post:
2005-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C427184', 'term': 'recombinant factor VIII SQ'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.'}], 'secondaryOutcomes': [{'measure': 'Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study.'}]}, 'conditionsModule': {'keywords': ['Hemophilia A'], 'conditions': ['Hemophilia A']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe hemophilia A\n* Previously treated patients with at least 150 exposure days to any Factor VIII product\n\nExclusion Criteria:\n\n* Hypersensitivity to any recombinant Factor VIII product\n* History of or current Factor VIII inhibitor\n* Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study'}, 'identificationModule': {'nctId': 'NCT00168051', 'briefTitle': 'Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-length Recombinant Factor VIII (FLrFVIII)', 'orgStudyIdInfo': {'id': '3082A-101711'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ReFacto', 'type': 'DRUG'}, {'name': 'Advante', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '75747', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '10249', 'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '48143', 'city': 'Münster', 'country': 'Germany', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '8001', 'city': 'Christchurch', 'country': 'New Zealand', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': 'M13 9WL', 'city': 'Manchester', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Germany, MedInfoDEU@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Italy, descresg@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Belgium, trials-BEL@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For Netherlands, trials-NL@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For New Zealand, medinfo@wyeth.com'}, {'name': 'Trial Manager', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'For UK, ukmedinfo@wyeth.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}