Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 1:37 PM
Study NCT ID:
NCT01145859
Status:
COMPLETED
Last Update Posted:
2015-08-06
First Post:
2010-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-05', 'studyFirstSubmitDate': '2010-06-16', 'studyFirstSubmitQcDate': '2010-06-16', 'lastUpdatePostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics parameters (AUC and Cmax)', 'timeFrame': 'From Day 1 to Day 2'}, {'measure': 'Pharmacodynamics parameters (PT, aPTT and anti-factor Xa)', 'timeFrame': 'From Day 1 to Day 2'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of rivaroxaban in pediatric subjects', 'timeFrame': 'Day 1, day 2 plus 7 days follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Venous Thrombosis', 'Pediatrics'], 'conditions': ['Venous Thrombosis', 'Pediatrics']}, 'referencesModule': {'references': [{'pmid': '30534008', 'type': 'DERIVED', 'citation': 'Willmann S, Thelen K, Kubitza D, Lensing AWA, Frede M, Coboeken K, Stampfuss J, Burghaus R, Muck W, Lippert J. Pharmacokinetics of rivaroxaban in children using physiologically based and population pharmacokinetic modelling: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:32. doi: 10.1186/s12959-018-0185-1. eCollection 2018.'}, {'pmid': '30534007', 'type': 'DERIVED', 'citation': 'Kubitza D, Willmann S, Becka M, Thelen K, Young G, Brandao LR, Monagle P, Male C, Chan A, Kennet G, Martinelli I, Saracco P, Lensing AWA. Exploratory evaluation of pharmacodynamics, pharmacokinetics and safety of rivaroxaban in children and adolescents: an EINSTEIN-Jr phase I study. Thromb J. 2018 Dec 4;16:31. doi: 10.1186/s12959-018-0186-0. eCollection 2018.'}, {'pmid': '23912563', 'type': 'DERIVED', 'citation': 'Willmann S, Becker C, Burghaus R, Coboeken K, Edginton A, Lippert J, Siegmund HU, Thelen K, Muck W. Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban. Clin Pharmacokinet. 2014 Jan;53(1):89-102. doi: 10.1007/s40262-013-0090-5.'}]}, 'descriptionModule': {'briefSummary': 'The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric subjects \\> 6 months and \\< 18 years of age at the time of administration of study drug.\n* Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE\n\nExclusion Criteria:\n\n* Any major or clinically relevant bleeding during prior VTE treatment\n* Abnormal coagulation tests within 7 days prior to study drug administration\n* Severe renal impairment\n* Planned invasive procedures prior to or after 24 hours of study drug administration'}, 'identificationModule': {'nctId': 'NCT01145859', 'briefTitle': 'Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism', 'orgStudyIdInfo': {'id': '12892'}, 'secondaryIdInfos': [{'id': '2009-017313-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Rivaroxaban (Xarelto, BAY59-7939)']}], 'interventions': [{'name': 'Rivaroxaban (Xarelto, BAY59-7939)', 'type': 'DRUG', 'description': 'Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72202-3500', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90027-6089', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': 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