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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02157987
• Date of registration: 04/06/2014
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Caen
• Public title: Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose EROSB
• Scientific title: Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose
• Date of first enrolment: December 15, 2014
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02157987
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Single (Care Provider).
• Phase: Phase 1/Phase 2

Countries of recruitment

France

Contacts

• Name: Babin Emmanuel, MD PhD

• Name: Laetitia ROBARD, MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Telangiectasia, Hereditary Hemorrhagic

Intervention(s)

Drug: bevacuzimab spray

Primary Outcome(s)

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

Secondary ID(s)

2013-004390-27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors