Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-01-11 @ 4:45 PM
Study NCT ID:
NCT03193502
Status:
UNKNOWN
Last Update Posted:
2017-10-13
First Post:
2017-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic PVT Compensated Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-12', 'studyFirstSubmitDate': '2017-06-17', 'studyFirstSubmitQcDate': '2017-06-17', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with recanalized portal vein', 'timeFrame': '6 months', 'description': 'recanalization of portal vein'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Portal Vein Thrombosis']}, 'descriptionModule': {'briefSummary': '-Rivaroxaban is factor Xa inhibitor', 'detailedDescription': 'PVT is a common complication of liver cirrhosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute PVT\n\nExclusion Criteria:\n\n* Malignant PVT\n* Bleeding disorders'}, 'identificationModule': {'nctId': 'NCT03193502', 'briefTitle': 'Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic PVT Compensated Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis', 'orgStudyIdInfo': {'id': 'Amr Hanafy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Portal Vein thrombosis', 'description': 'rivaroxaban', 'interventionNames': ['Drug: rivaroxaban']}], 'interventions': [{'name': 'rivaroxaban', 'type': 'DRUG', 'otherNames': ['xarelto'], 'description': 'rivaroxaban', 'armGroupLabels': ['Portal Vein thrombosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Sherief Abd-Elsalam', 'role': 'CONTACT', 'email': 'Sherif_tropical@yahoo.com', 'phone': '00201095159522'}], 'facility': 'Tropical medicine dept.-Tanta university hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Sherief Abd-Elsalam, consultant', 'role': 'CONTACT', 'email': 'Sheriefabdelsalam@yahoo.com', 'phone': '00201095159522'}], 'overallOfficials': [{'name': 'Amr Hanafy, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hepatology unit - Zagazig University'}, {'name': 'Mohamed Basha, Consultant', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Radiology Dept - Zagazig University'}, {'name': 'Sherief Abd-elsalam, consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'Hepatology - Gastroenterology - Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sherief Abd-Elsalam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}