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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Telangiectasia, Hereditary Hemorrhagic | Drug: bevacuzimab spray | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
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 |
Actual Study Start Date : | December 15, 2014 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: bevacizumab
bevacizumab spray
|
Drug: bevacuzimab spray |
- decrease of at least 50% of number of epistaxis in a month compared to the month before inclusion. [ Time Frame: one month ]

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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 |
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

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
Contact: Laetitia ROBARD, MD | 33231064388 | robard-l@chu-caen.fr | |
Contact: Emmanuel BABIN, MD-PHD | 33231064388 | babin-e@chu-caen.fr |
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 |
Responsible Party: | University Hospital, Caen |
ClinicalTrials.gov Identifier: | NCT02157987 |
Other Study ID Numbers: |
2013-004390-27 |
First Posted: | June 6, 2014 Key Record Dates |
Last Update Posted: | October 5, 2020 |
Last Verified: | October 2020 |
telangietasia hereditary hemorragic epistaxis safety |
quality of life bevacizumab spray |
Telangiectasis Telangiectasia, Hereditary Hemorrhagic Vascular Diseases Cardiovascular Diseases Hemostatic Disorders |
Hemorrhagic Disorders Hematologic Diseases Vascular Malformations Cardiovascular Abnormalities Congenital Abnormalities |