BABH Study: Efficacy and safety of bevacizumab on severe bleedings associated with Hemorrhagic Hereditary Telangiectasia (HHT)

Phase 1

• Conditions: Hemorrhagic Hereditary Telangiectasia; MedDRA version: 20.0Level: LLTClassification code 10031132Term: Osler-Weber-Rendu diseaseSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2017-001031-39-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-19
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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 three Curaçao criteria) and / or with molecular biology confirmation.
- Blood transfusions with the requirement for at least 3 units of blood in the 3-month period before study enrollment, related to epistaxis or digestive bleeding.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

- Pregnant or nursing (lactating) women or likely to become so in the course of the study.
- 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 study.
- Active infection and/or fever>38°C
- Participation in another clinical trial within 28 days prior to inclusion.
- Hypersensitivity to the active substance or to any of the excipients.
- Known hypersensitivity to products of Chinese hamster ovary cells (CHO) or other recombinant human or humanized antibodies.
- Patients who have taken Avastin ® intravenously in the 6 months prior to inclusion.
- Patients who have had a therapeutic endoscopy for gastrointestinal bleeding or ENT surgery for epistaxis will have to wait at least 3 months less after treatment to be included if bleeding persists.
- Patients who had a surgery in the month prior inclusion or planned surgery within 6 months
- Severe peripheral arterial disease with ulcerations
- Unhealed wound

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified