Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT00038935
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2002-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'D005169', 'term': 'Factor VIII'}], 'ancestors': [{'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-18', 'studyFirstSubmitDate': '2002-06-05', 'studyFirstSubmitQcDate': '2002-06-06', 'lastUpdatePostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-02', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Hemophilia'], 'conditions': ['Hemophilia A']}, 'referencesModule': {'references': [{'pmid': '29575770', 'type': 'DERIVED', 'citation': 'Korth-Bradley J, Rupon J, Plotka A, Charnigo R, Rendo P. Assessment of Relative Bioavailability of Moroctocog Alfa and Moroctocog Alfa (AF-CC) in Subjects With Severe Hemophilia A. Clin Transl Sci. 2018 May;11(3):283-288. doi: 10.1111/cts.12544. Epub 2018 Mar 25.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the relative bioavailability of ReFacto AF as compared to ReFacto, when each is administered as 2-minute bolus infusions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe hemophilia A (FVIII:C \\< 1% at local laboratory)\n* Previously treated patients (PTP) with at least 250 exposure days to any factor VIII product\n* Age greater than or equal to 12 years\\\\\n\nExclusion Criteria:\n\n* The presence of any bleeding disorder in addition to hemophilia A\n* Concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (IVIG), routine systemic corticosteroid use)\n* History of detectable factor VIII inhibitor'}, 'identificationModule': {'nctId': 'NCT00038935', 'briefTitle': 'Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'A Single Dose, Randomized, Double-Blind, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of B-Domain Deleted Recombinant Human Factor VIII (BDDrFVIII) Manufactured by the Current Process (ReFacto) and by an Albumin Free Manufacturing Process (ReFacto AF)', 'orgStudyIdInfo': {'id': '3082B1-305'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ReFacto AF', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wyeth is now a wholly owned subsidiary of Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}}}}