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CompletedNCT02157987EROSBUpdated Jul 30, 2026

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

A Phase 1/2 interventional study of bevacuzimab spray in Telangiectasia, Hereditary Hemorrhagic, sponsored by University Hospital, Caen. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by University Hospital, Caen · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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Conditions studied

  • Telangiectasia, Hereditary Hemorrhagic

Keywords

  • telangietasia hereditary hemorragic
  • epistaxis
  • safety
  • quality of life
  • bevacizumab
  • spray
03

In context

Telangiectasia, Hereditary Hemorrhagic

106 studies on the registry are indexed under Telangiectasia, Hereditary Hemorrhagic; 24 are open to participants now.

This study's enrollment of 20 is below the median of 33 across 61 interventional studies indexed under Telangiectasia, Hereditary Hemorrhagic.

Browse Telangiectasia, Hereditary Hemorrhagic studies →

Lead sponsor

University Hospital, Caen is the lead sponsor of 512 studies on the registry; 82 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 during the treatment and for 6 months after stopping

Exclusion criteria

Exclusion Criteria:

General criteria:

  • Pregnant women, breastfeeding
  • to the active substance or any of its
  • 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Care provider)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    bevacizumab

    bevacizumab spray

    Drug: bevacuzimab spray

Interventions

  • Drugbevacuzimab spray
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What researchers measure

Primary outcomes

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

    Time frame: one month

07

Study locations

1 site
  • CHU de Caen
    Caen, 14033, France
08

References and documents

Publications

  • Vincent L, Robard L, Creveuil C, Babin E, Perreard M, Humbert M. Treatment of epistaxis in Osler-Weber-Rendu disease by bevacizumab nasal spray. The EROSB study: Determining the effective dose. Eur Ann Otorhinolaryngol Head Neck Dis. 2025 Mar;142(2):67-73. doi: 10.1016/j.anorl.2024.10.006. Epub 2024 Nov 6. PubMed 39510938 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02157987
Responsible party
Sponsor
First posted
Jun 6, 2014
Start date
Dec 15, 2014
Primary completion
Oct 8, 2020
Completion
Dec 8, 2021
Last update
Jul 30, 2026

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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