Efficacy of a Bevacizumab Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT02106520
• Date of registration: 01/04/2014
• Prospective Registration: Yes
• Primary sponsor: Hospices Civils de Lyon
• Public title: Efficacy of a Bevacizumab Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) ALEGORI
• Scientific title: Efficacy of a Bevacizumab Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
• Date of first enrolment: April 2014
• Target sample size: 80
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02106520
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Sophie DUPUIS-GIROD, MD
• Affiliation: Service de génétique, Hôpital Louis Pradel, Hospices Civils de Lyon

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age = 18 years.

- Patients who have given their free informed and signed consent.

- Patients affiliated to a social security scheme or similar.

- Patients monitored for clinically confirmed HHT (presence of at least 3 Curaçao
criteria) and/or confirmed by molecular biology.

- Patients who have not undergone nasal surgery in the 3 months prior to inclusion.

- Patient with nosebleeds of a monthly duration of more than 20 minutes and justified
by follow-up grids completed for at least the 3 months prior to the time of
inclusion.

Exclusion Criteria:

- Women who are pregnant or likely to become so in the course of the study.

- Patients not affiliated to a social security scheme.

- Patients who are protected adults under the terms of the law (French Public Health
Code).

- Refusal to consent.

- Patients for whom the diagnosis of HHT has not been confirmed clinically and/or by
molecular biology.

- Patients with an on-going infectious condition.

- Participation in another clinical trial within the 28 days prior to inclusion.

- Known hypersensitivity to the active ingredient or one of the excipients.

- Known hypersensitivity to products of Chinese hamster ovary cells (CHO) or other
human or humanized recombinant antibodies.

- Patients who have incompletely filled in the nosebleed grids in the 3 months
preceding the treatment.

- Patients who do not present with nosebleeds with a monthly average duration over the
3 months preceding the treatment of more than 20 minutes ((duration M1 + duration M2
+ duration M3) / 3). Remark: only the 3 months strictly preceding the treatment will
be taken into account, even if the grids have been completed over a longer period.

- Patients who have received Avastin® intravenously in the 6 months prior to inclusion.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Epistaxis

Hereditary Hemorrhagic Telangiectasia

Intervention(s)

Drug: Bevacizumab

Drug: placebo

Primary Outcome(s)

mean duration of epistaxis [Time Frame: 3 months after treatment]

Secondary Outcome(s)

mean monthly epistaxis duration [Time Frame: 6 months after the end of the treatment]

frequency and duration of epistaxis [Time Frame: 3 months and 6 months after the end of the treatment]

Number of red blood cells transfusion [Time Frame: 3 months and 6 months after the end of the treatment]

Change in hemoglobinemia and serum ferritin [Time Frame: 1 month, 3 months and 6 months]

adverse events [Time Frame: before and 6 months after treatment]

Kinetics of monthly epistaxis duration [Time Frame: 6 months]

Quality of life [Time Frame: 3 months and 6 months aftert the end of the treatment]

Secondary ID(s)

2013.827

Source(s) of Monetary Support

Please refer to primary and secondary sponsors