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

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ClinicalTrials.gov Identifier: NCT02157987
Recruitment Status : Unknown
Verified January 2015 by University Hospital, Caen.
Recruitment status was:  Recruiting
First Posted : June 6, 2014
Last Update Posted : January 27, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

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.

Condition or disease Intervention/treatment Phase
Telangiectasia, Hereditary Hemorrhagic Drug: bevacuzimab spray Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017


Arm Intervention/treatment
Experimental: bevacizumab
bevacizumab spray
Drug: bevacuzimab spray



Primary Outcome Measures :
  1. decrease of at least 50% of number of epistaxis in a month compared to the month before inclusion. [ Time Frame: one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157987


Contacts
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Contact: Laetitia ROBARD, MD 33231064388 robard-l@chu-caen.fr
Contact: Emmanuel BABIN, MD-PHD 33231064388 babin-e@chu-caen.fr

Locations
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France
CHU de Caen Recruiting
Caen, France, 14033
Contact: Babin Emmanuel, MD PhD    33231064388    babin-e@chu-caen.fr   
Contact: Robard Laetitia, MD    33231064388    robard-l@chu-caen.fr   
Principal Investigator: Robard Laetitia, MD         
Sub-Investigator: Babin Emmanuel, MD PhD         
Sub-Investigator: Zalcman Gérard, MD PhD         
Sponsors and Collaborators
University Hospital, Caen

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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02157987     History of Changes
Other Study ID Numbers: 2013-004390-27
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: January 2015
Keywords provided by University Hospital, Caen:
telangietasia hereditary hemorragic
epistaxis
safety
quality of life
bevacizumab
spray
Additional relevant MeSH terms:
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Telangiectasis
Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors