Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-28 @ 9:17 PM
Study NCT ID:
NCT01031992
Status:
COMPLETED
Last Update Posted:
2009-12-15
First Post:
2009-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013683', 'term': 'Telangiectasia, Hereditary Hemorrhagic'}, {'id': 'D004844', 'term': 'Epistaxis'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013684', 'term': 'Telangiectasis'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2002-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-12', 'studyFirstSubmitDate': '2009-12-11', 'studyFirstSubmitQcDate': '2009-12-12', 'lastUpdatePostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of hemoglobin level within the phases.', 'timeFrame': 'Beginning and end of each 3 months period.'}], 'secondaryOutcomes': [{'measure': 'Mean epistaxis score (daily duration multiplied by mean subjective daily intensity)', 'timeFrame': 'Measured once a day during each 3 months period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hereditary hemorrhagic telangiectasia', 'Rendu-Osler-Weber syndrome', 'Epistaxis', 'Nosebleeds', 'Anemia', 'Tranexamic acid', 'Antifibrinolytics'], 'conditions': ['Hereditary Hemorrhagic Telangiectasia']}, 'referencesModule': {'references': [{'pmid': '25005464', 'type': 'DERIVED', 'citation': 'Geisthoff UW, Seyfert UT, Kubler M, Bieg B, Plinkert PK, Konig J. Treatment of epistaxis in hereditary hemorrhagic telangiectasia with tranexamic acid - a double-blind placebo-controlled cross-over phase IIIB study. Thromb Res. 2014 Sep;134(3):565-71. doi: 10.1016/j.thromres.2014.06.012. Epub 2014 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'Hereditary hemorrhagic telangiectasia (HHT, Rendu-Osler-Weber Syndrome) is associated with frequent nosebleeds in the majority of cases. Several reports in the literature support the use of antifibrinolytics like Tranexamic acid to reduce nosebleeds. The objectives of the study are to test if Tranexamic acid taken orally can\n\n1. improve anemia (lead to an increased hemoglobin level)\n2. reduce nosebleeds.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hereditary hemorrhagic telangiectasia with nosebleeds and desire to be treated.\n\nExclusion Criteria:\n\n* pregnant,\n* minor,\n* had an increased risk of thrombotic events (history or signs of cerebrovascular events, cardiac arrhythmias, biochemically increased coagulation parameters),\n* renal insufficiency,\n* a history of massive hematuria or defects of color vision.'}, 'identificationModule': {'nctId': 'NCT01031992', 'acronym': 'TAHHT', 'briefTitle': 'Tranexamic Acid and Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Saarland'}, 'officialTitle': 'Efficacy of Tranexamic Acid Taken Orally in Patients With Hereditary Hemorrhagic Telangiectasia', 'orgStudyIdInfo': {'id': 'TAHHT'}, 'secondaryIdInfos': [{'id': '141CHC9008-001', 'type': 'OTHER', 'domain': 'BfArM (German Federal Institute for Drugs and Medical Products)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I', 'description': 'First verum (3 times 1 g Tranexamic acid daily) for three months, than placebo for 3 months.', 'interventionNames': ['Drug: Tranexamic acid first, than placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group II', 'description': 'First placebo for 3 months, than verum for 3 months (3 times 1 g Tranexamic acid daily).', 'interventionNames': ['Drug: First placebo, than Tranexamic acid.']}], 'interventions': [{'name': 'Tranexamic acid first, than placebo', 'type': 'DRUG', 'description': 'For 3 months Tranexamic acid 3 times daily 1 g taken orally, followed by placebo for 3 months.', 'armGroupLabels': ['Group I']}, {'name': 'First placebo, than Tranexamic acid.', 'type': 'DRUG', 'description': 'First placebo for 3 months, than tranexamic acid 3 times daily 1 g for 3 months.', 'armGroupLabels': ['Group II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66421', 'city': 'Homburg', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Universitätskliniken des Saarlandes, HNO-Abteilung', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'overallOfficials': [{'name': 'Urban W Geisthoff, Priv.-Doz. Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Faculty of the University of the Saarland and Hospitals of the City of Cologne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pharmacia GmbH, Erlangen, Germany', 'class': 'UNKNOWN'}, {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Universitätskliniken des Saarlandes'}}}}