Status:
COMPLETED
BABH Study: Efficacy and Safety of Bevacizumab on Severe Bleedings Associated With Hemorrhagic Hereditary Telangiectasia (HHT).
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Rendu Osler Disease
Telangiectasia, Hereditary Hemorrhagic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The recognized manifestations of HHT are all due to abnormalities of vascular structure. Epistaxis and digestive arteriovenous malformations may be responsible for severe hemorrhages in 5% of HHT pati...
Eligibility Criteria
Inclusion
- 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 4 units of blood in the 3-month period before study enrollment, related to epistaxis or digestive bleeding.
Exclusion
- Women who are pregnant or nursing (lactating), women of child-bearing potential without reliable contraception during the treatment and for at least 6 months after the last dose.
- 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
- Thrombosis in the 6 months prior to inclusion
- Anticoagulant treatment
- Uncontrolled high blood pressure
Key Trial Info
Start Date :
September 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03227263
Start Date
September 28 2017
End Date
May 15 2020
Last Update
August 6 2025
Active Locations (4)
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1
CHU d'Angers
Angers, France
2
Hôpital Ambroise Paré
Boulogne-Billancourt, France
3
Hôpital Femme Mère Enfant
Bron, France
4
CHU de Montpellier Hôpital St Eloi
Montpellier, France