Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose

NCT ID: NCT02157987

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-15
• Study Completion Date: 2021-12-08

Brief Summary

Epistaxis are present in over 90 % of patients with Rendu - Osler . They involve no significant difference 2 sexes. They often appear in childhood and adolescence and are present in three-quarters of patients at the age of 20 years. These epistaxis increasing in frequency and volume to the age of 60 in 2/3 of patients. Epistaxis are spontaneous , repetitive and recurring . They are highly variable in duration, intensity and frequency of occurrence . Some patients may have more than 40 monthly episodes with mean duration of 5 minutes of bleeding and chronic anemia and can sometimes acute anemia with transfusions need to be source. These epistaxis stigmatize patients and inevitably affect their quality of life and social skills . The various proposed ( cauterization , intra- mucosal injections, laser selective hémostatses , embolization or surgical dermoplasties ) allow for some short-term remissions . Bevacizumab is an antiangiogenic use in the treatment of colorectal cancers . It is also used in ophthalmology intravitreal to reduce vascular proliferation in glaucoma retinopathy and certain corneal neovascularization. In 2009, Prithviraj reported the use of bevacizumab injection to treat pulmonary arteriovenous malformations in a patient with Rendu - Osler . The result is doubly interesting including a saving action on epistaxis which decrease in frequency and duration. This communication prompted the authors to focus more on this medication. The product has been used in local submucosal injection intranasal laser was coupled with satisfactory results objectified by a decrease in the number of epistaxis , reducing blood transfusions and improved social lives. The use of local instillation bevacuzimab represents a way forward for the treatment of these epistaxis.

Conditions

Telangiectasia, Hereditary Hemorrhagic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

bevacizumab

bevacizumab spray

Group Type: EXPERIMENTAL

bevacuzimab spray

Intervention Type: DRUG

Interventions

bevacuzimab spray

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients with Rendu-Osler-Weber disease
• patients with iterative epistaxis (at least 10 per month)
• patients without treatment for 3 months with usual techniques (for the epistaxis)
• patients speaking french fluently
• patients with written consents
• affiliation to social security
• women with effective contraception during the treatment and for 6 months after stopping

Exclusion Criteria

General criteria:

• Pregnant women, breastfeeding
• Hypersensitivity to the active substance or any of its excipients
• Hypersensitivity to the products of Chinese hamster ovary cells or other human or humanized recombinant antibodies
• Inability to undergo medical monitoring due to reasons geographical, social or psychological
• Patient under guardianship
• Patient included in another biomedical research protocol

Related to medical history criteria:

• Uncontrolled hypertension ( systolic BP > or = 150 mmHg and / or Diastolic BP > or = 100 mmHg)
• Thrombocytopenia <100 G / L
• Taking NSAIDs within ten days prior to inclusion
• Anticoagulant therapy or thrombolytic within 28 days before inclusion
• Tumor, genetic predisposition to bleeding, coagulopathy , patient receiving treatment full anticoagulant dose for an event thromboembolism prior to inclusion
• Major surgery within 28 days prior to inclusion
• History of thromboembolic disease within 6 months prior to enrollment
• Arteriovenous malformation localized to the brain, liver or lung on scanner older than 5 years
• History of heart failure
• Patients with proteinuria / creatinine greater than 2g / g

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Caen

Caen, , France

Countries

France

Other Identifiers

2013-004390-27

Identifier Type: -

Identifier Source: org_study_id