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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 : Recruiting
First Posted : June 6, 2014
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Tracking Information
First Submitted Date  ICMJE June 4, 2014
First Posted Date  ICMJE June 6, 2014
Last Update Posted Date October 5, 2020
Actual Study Start Date  ICMJE December 15, 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2014)
decrease of at least 50% of number of epistaxis in a month compared to the month before inclusion. [ Time Frame: one month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose
Official Title  ICMJE Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Telangiectasia, Hereditary Hemorrhagic
Intervention  ICMJE Drug: bevacuzimab spray
Study Arms  ICMJE Experimental: bevacizumab
bevacizumab spray
Intervention: Drug: bevacuzimab spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laetitia ROBARD, MD 33231064388 robard-l@chu-caen.fr
Contact: Emmanuel BABIN, MD-PHD 33231064388 babin-e@chu-caen.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02157987
Other Study ID Numbers  ICMJE 2013-004390-27
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Caen
Study Sponsor  ICMJE University Hospital, Caen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Caen
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP