Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-02-19 @ 5:45 PM
Study NCT ID:
NCT01579903
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
2012-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Greece', 'Poland']}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-07', 'studyFirstSubmitDate': '2012-04-16', 'studyFirstSubmitQcDate': '2012-04-16', 'lastUpdatePostDateStruct': {'date': '2013-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (primary PK parameters include: Cmax, AUClast, and AUCinf)', 'timeFrame': 'Periods 1 and 2, Day 1 through 4'}], 'secondaryOutcomes': [{'measure': 'Single dose pharmacokinetics of moroctocog alfa (AF-CC) using noncompartmental analysis (secondary PK parameters include: tmax, λz, t1/2, CL, Vss, and FVIII Recovery)', 'timeFrame': 'Periods 1 and 2, Day 1 through Day 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemophilia A', 'moroctocog alfa (AF-CC)', 'ReFacto AF', 'dual-chamber syringe', 'bioavailability'], 'conditions': ['Hemophilia A']}, 'referencesModule': {'references': [{'pmid': '27140804', 'type': 'DERIVED', 'citation': 'Shafer F, Charnigo RJ, Plotka A, Baumann J, Liang Y, Korth-Bradley J. Assessment of relative bioavailability of two presentations of moroctocog alfa (AF-CC) in subjects with moderately severe or severe hemophilia A. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):237-41. doi: 10.1002/cpdd.168. Epub 2014 Oct 27.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1831077&StudyName=Relative%20Bioavailability%20Of%20Two%20Formulations%20Of%20Moroctocog%20Alfa%20%28AF-CC%29', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation.', 'detailedDescription': 'This study is being conducted in order to satisfy a post-approval EMA commitment to compare the pharmacokinetics of the 2 dose presentations used in this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients at least 18 years old with severe or moderately severe hemophilia A (facto VIII concentration less than or equal to 2%).\n* Negative test for facto VIII inhibitor.\n* If applicable, HIV or hepatitis treatment is stable at the time of enrollment.\n* Ability to abstain from use of FVIII products for 72 hours at a time.\n\nExclusion Criteria:\n\n* History of any positive test result for factor VIII inhibitor.\n* Presence of any bleeding disorder in addition to Hemophilia A.\n* Body weight less than 50 kg.\n* History of alcoholism.\n* Treatment with investigational drug or device within 30 days prior to the Screening visit.'}, 'identificationModule': {'nctId': 'NCT01579903', 'briefTitle': 'Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open-Label, Randomized, Two-period Crossover Study To Compare Relative Bioavailability of Two Formulations of Moroctocog Alfa (Af-cc) In Subjects With Moderately Severe Or Severe Hemophilia A (FVIII:C </=2%)', 'orgStudyIdInfo': {'id': 'B1831077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1', 'description': 'Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2.', 'interventionNames': ['Drug: moroctocog alfa (AF-CC)']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2', 'description': 'Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2.', 'interventionNames': ['Drug: moroctocog alfa (AF-CC)']}], 'interventions': [{'name': 'moroctocog alfa (AF-CC)', 'type': 'DRUG', 'description': 'Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent); Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes', 'armGroupLabels': ['Sequence 1']}, {'name': 'moroctocog alfa (AF-CC)', 'type': 'DRUG', 'description': 'Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes; Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent)', 'armGroupLabels': ['Sequence 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1612', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}