Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-25 @ 6:30 PM
Study NCT ID:
NCT02106520
Status:
TERMINATED
Last Update Posted:
2015-11-20
First Post:
2014-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Bevacizumab Nasal Spray as a Treatment for 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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': "DSMB's decision following the first step analysis", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-19', 'studyFirstSubmitDate': '2014-04-01', 'studyFirstSubmitQcDate': '2014-04-03', 'lastUpdatePostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean duration of epistaxis', 'timeFrame': '3 months after treatment', 'description': 'To evaluate 3 months after the end of the treatment the efficacy on the duration of the nosebleeds with 3 different doses (25, 50 and 75 mg) of bevacizumab administered as a nasal spray in a repeated manner (3 administrations).'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': 'before and 6 months after treatment', 'description': 'Adverse events observed along a repeated administration of bevacizumab (nasal spray administration) : evaluation by epistaxis monitoring along the study and by a clinical exam before each treatment and 6 months after the end of the treatment.'}, {'measure': 'mean monthly epistaxis duration', 'timeFrame': '6 months after the end of the treatment', 'description': 'To evaluate the efficacy at 6 months after the end of the treatment on the duration of the nosebleeds for the dose retained versus placebo'}, {'measure': 'frequency and duration of epistaxis', 'timeFrame': '3 months and 6 months after the end of the treatment', 'description': 'Evolution of the frequency and the mean monthly duration of epistaxis at 3 and 6 months for the dose retained'}, {'measure': 'Quality of life', 'timeFrame': '3 months and 6 months aftert the end of the treatment', 'description': 'Evolution of the quality of life score (SF-36) between the inclusion, 3 months and 6 months after the end of the treatment'}, {'measure': 'Number of red blood cells transfusion', 'timeFrame': '3 months and 6 months after the end of the treatment', 'description': 'Evolution of the number of red blood cells transfusion between the inclusion and 3 and 6 months after the end of the treatment.'}, {'measure': 'Change in hemoglobinemia and serum ferritin', 'timeFrame': '1 month, 3 months and 6 months', 'description': 'Evolution of hemoglobinemia and serum ferritin at inclusion,3 and 6 months after the end of the treatment for the retained dose'}, {'measure': 'Kinetics of monthly epistaxis duration', 'timeFrame': '6 months', 'description': 'To describe the nosebleed kinetics for the dose retained and the placebo throughout the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Epistaxis', 'Bevacizumab'], 'conditions': ['Hereditary Hemorrhagic Telangiectasia', 'Epistaxis']}, 'referencesModule': {'references': [{'pmid': '27599328', 'type': 'DERIVED', 'citation': 'Dupuis-Girod S, Ambrun A, Decullier E, Fargeton AE, Roux A, Breant V, Colombet B, Riviere S, Cartier C, Lacombe P, Chinet T, Blivet S, Blondel JH, Gilbert-Dussardier B, Dufour X, Michel J, Harle JR, Dessi P, Faure F. Effect of Bevacizumab Nasal Spray on Epistaxis Duration in Hereditary Hemorrhagic Telangectasia: A Randomized Clinical Trial. JAMA. 2016 Sep 6;316(9):934-42. doi: 10.1001/jama.2016.11387.'}]}, 'descriptionModule': {'briefSummary': 'Hereditary Hemorrhagic Telangiectasia (HHT) is a rare (\\~ 1/6000) but ubiquitous genetic disease. It is associated with abnormal angiogenesis and autosomal dominant inheritance, leading to telangiectasias and arteriovenous fistulae. More than 95% of patients are concerned by epistaxis (nosebleeds). These events are spontaneous, repeated, irregular, both diurnal and nocturnal, a source of anemia, disabling and very socially embarrassing.\n\nAnti-angiogenic treatments, including bevacizumab, are a new therapeutic option in HHT.\n\nThe aim of this study is to evaluate 3 months after the end of the treatment the efficacy on the duration of the nosebleeds with 3 different doses (25, 50 and 75 mg) of bevacizumab administered as a nasal spray in a repeated manner (3 administrations) in patients with Hereditary Hemorrhagic Telangiectasia complicated by nosebleeds.\n\nThis randomized, double-blind, placebo-controlled, seamless phase II/III study is to be carried out on 4 groups of 20 patients for first step and 2 groups of 20 to 40 patients for second step'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Patients who have given their free informed and signed consent.\n* Patients affiliated to a social security scheme or similar.\n* Patients monitored for clinically confirmed HHT (presence of at least 3 Curaçao criteria) and/or confirmed by molecular biology.\n* Patients who have not undergone nasal surgery in the 3 months prior to inclusion.\n* Patient with nosebleeds of a monthly duration of more than 20 minutes and justified by follow-up grids completed for at least the 3 months prior to the time of inclusion.\n\nExclusion Criteria:\n\n* Women who are pregnant or likely to become so in the course of the study.\n* Patients not affiliated to a social security scheme.\n* Patients who are protected adults under the terms of the law (French Public Health Code).\n* Refusal to consent.\n* Patients for whom the diagnosis of HHT has not been confirmed clinically and/or by molecular biology.\n* Patients with an on-going infectious condition.\n* Participation in another clinical trial within the 28 days prior to inclusion.\n* Known hypersensitivity to the active ingredient or one of the excipients.\n* Known hypersensitivity to products of Chinese hamster ovary cells (CHO) or other human or humanized recombinant antibodies.\n* Patients who have incompletely filled in the nosebleed grids in the 3 months preceding the treatment.\n* Patients who do not present with nosebleeds with a monthly average duration over the 3 months preceding the treatment of more than 20 minutes ((duration M1 + duration M2 + duration M3) / 3). Remark: only the 3 months strictly preceding the treatment will be taken into account, even if the grids have been completed over a longer period.\n* Patients who have received Avastin® intravenously in the 6 months prior to inclusion.'}, 'identificationModule': {'nctId': 'NCT02106520', 'acronym': 'ALEGORI', 'briefTitle': 'Efficacy of a Bevacizumab Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Efficacy of a Bevacizumab Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)', 'orgStudyIdInfo': {'id': '2013.827'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bevacizumab 25mg', 'description': 'Three administrations of 25 mg of Bevacizumab spaced of 14 days', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Bevacizumab 50mg', 'description': 'Three administrations of 50 mg of Bevacizumab spaced of 14 days', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Bevacizumab 75mg', 'description': 'Three administrations of 75 mg of Bevacizumab spaced of 14 days', 'interventionNames': ['Drug: Bevacizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Three administrations of placebo spaced of 14 days', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Three administrations of Bevacizumab spaced of 14 days'], 'armGroupLabels': ['Bevacizumab 25mg', 'Bevacizumab 50mg', 'Bevacizumab 75mg']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['Three administrations of placebo spaced of 14 days'], 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'Sophie DUPUIS-GIROD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de génétique, Hôpital Louis Pradel, Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}