Telangiectasia, Hereditary HemorrhagicPhase 1/2EROSBNCT02157987
Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose
A Phase 1/2 study testing bevacuzimab spray in people with Telangiectasia, Hereditary Hemorrhagic, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Telangiectasia, Hereditary Hemorrhagic
- What is being tested?
- bevacuzimab spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2014to 8 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- bevacuzimab spray
- Keywords
- telangietasia hereditary hemorragic, epistaxis, safety, quality of life, bevacizumab, spray
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic, Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacuzimab sprayDrug
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Experimental | bevacizumab spray Receives: Drug: bevacuzimab spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
decrease of at least 50% of number of epistaxis in a month compared to the month before inclusion.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study start15 Dec 2014
- Primary completion8 Oct 2020
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Telangiectasia, Hereditary HemorrhagicStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157987
- Sponsor's protocol ID
- 2013-004390-27
- Acronym
- EROSB
- Status last verified
- Apr 2025
- First submitted
- 4 Jun 2014
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose
- ClinicalTrials.gov ID
- NCT02157987
- Acronym / sponsor ID
- EROSB / 2013-004390-27
- Conditions
- Telangiectasia, Hereditary Hemorrhagic
- Keywords
- telangietasia hereditary hemorragic, epistaxis, safety, quality of life, bevacizumab, spray
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 15 Dec 2014 (actual)
- Primary completion
- 8 Oct 2020 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Experimental | Drug: bevacuzimab spraybevacizumab spray |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacuzimab spray | Drug | bevacizumab |
Primary outcome
decrease of at least 50% of number of epistaxis in a month compared to the month before inclusion.
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Results publication: PubMed 39510938Vincent 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bevacuzimab spray in people with Telangiectasia, Hereditary Hemorrhagic, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease of at least 50% of number of epistaxis in a month compared to the month before inclusion. (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157987, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.