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

Primary Purpose

Telangiectasia, Hereditary Hemorrhagic

Status
Unknown status
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
bevacuzimab spray
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telangiectasia, Hereditary Hemorrhagic focused on measuring telangietasia hereditary hemorragic, epistaxis, safety, quality of life, bevacizumab, spray

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de CaenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bevacizumab

Arm Description

bevacizumab spray

Outcomes

Primary Outcome Measures

decrease of at least 50% of number of epistaxis in a month compared to the month before inclusion.

Secondary Outcome Measures

Full Information

First Posted
June 4, 2014
Last Updated
October 2, 2020
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02157987
Brief Title
Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose
Acronym
EROSB
Official Title
Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2014 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telangiectasia, Hereditary Hemorrhagic
Keywords
telangietasia hereditary hemorragic, epistaxis, safety, quality of life, bevacizumab, spray

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Care Provider
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bevacizumab
Arm Type
Experimental
Arm Description
bevacizumab spray
Intervention Type
Drug
Intervention Name(s)
bevacuzimab spray
Primary Outcome Measure Information:
Title
decrease of at least 50% of number of epistaxis in a month compared to the month before inclusion.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laetitia ROBARD, MD
Phone
33231064388
Email
robard-l@chu-caen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuel BABIN, MD-PHD
Phone
33231064388
Email
babin-e@chu-caen.fr
Facility Information:
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Babin Emmanuel, MD PhD
Phone
33231064388
Email
babin-e@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Robard Laetitia, MD
Phone
33231064388
Email
robard-l@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Robard Laetitia, MD
First Name & Middle Initial & Last Name & Degree
Babin Emmanuel, MD PhD
First Name & Middle Initial & Last Name & Degree
Zalcman Gérard, MD PhD

12. IPD Sharing Statement

Learn more about this trial

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

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