Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-04-14 @ 6:41 PM
Study NCT ID:
NCT01848002
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
2013-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-25', 'studyFirstSubmitDate': '2013-05-02', 'studyFirstSubmitQcDate': '2013-05-02', 'lastUpdatePostDateStruct': {'date': '2013-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'Days 0-33'}], 'secondaryOutcomes': [{'measure': 'Incidence of clinically significant changes from baseline in physical examination or laboratory measurements', 'timeFrame': 'From days -1 through day 33'}, {'measure': 'Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay)', 'timeFrame': 'From days -1 through day 33'}, {'measure': 'Incidence of yeast antibodies', 'timeFrame': 'From days -1 through day 33'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Bleeding Disorder', 'Congenital FXIII Deficiency', 'Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': 'This trial was conducted in Europe. The aim of this trial was to investigate safety and pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal platelet count and clotting parameters\n* Adequate renal and hepatic function\n* Negative serum pregnancy test within 21 days prior to enrollment and negative urine pregnancy test on admission to the clinical research unit (if subject female and of child-bearing potential)\n* Agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits (if subject a sexually active male or female of childbearing potential)\n* Negative drug and negative alcohol screens\n\nExclusion Criteria:\n\n* Known antibodies or hypersensitivity to FXIII\n* Known bleeding or hematologic disorder\n* Known allergy to yeast\n* Receipt of blood products within 30 days of screening\n* Donation of blood within 30 days prior to enrollment\n* Surgical procedure of any type within 30 days prior to enrollment\n* History of autoimmune disorders involving autoantibodies, e.g., systemic lupus erythematosus\n* Treatment with any experimental agent within 30 days of study enrollment'}, 'identificationModule': {'nctId': 'NCT01848002', 'briefTitle': 'Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Double-Blind, Multi-dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'F13-1662'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rFXIII', 'interventionNames': ['Drug: catridecacog']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'catridecacog', 'type': 'DRUG', 'description': 'For 5 consecutive days, one daily dose of rFXIII was administered intravenously (IV) to eight subjects in each dose group (10 or 25 U/kg).', 'armGroupLabels': ['rFXIII']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'For 5 consecutive days, one daily dose of placebo was administered intravenously (IV) to two subjects in each dose group (10 or 25 U/kg).', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SL1 2 AD', 'city': 'Berkshire', 'country': 'United Kingdom'}], 'overallOfficials': [{'name': 'Global Clinical Registry (GCR, 1452)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}