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Clinical Trial 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 patients, requiring repeated blood transfusions and are associated with high morbidity. There is currently no standard and efficient management of this severe symptom. It is also well known that HHT-associated hemorrhages have the greatest negative impact on quality of life among HHT patients, and is responsible for anemia, blood transfusions, hospitalizations, depressive syndrome and a high psycho-social impact. Since 2006, it has been suggested by animal models and then by clinical reports that anti-VEGF therapy may be useful to treat HHT. 4 case reports have been published on efficacy of intravenous bevacizumab, a humanized monoclonal antibody in HHT on severe hemorrhages. Intravenous bevacizumab has been used in a previous clinical trial to measure efficacy and tolerance of this drug in HHT patients with severe liver involvement. Furthermore, a reduction was observed in the duration of the nosebleeds after treatment and was encouraging to treat bleeding. We completed this study by a pharmacokinetic-pharmacodynamic (PK-PD) model in order to assess the individual concentration-effect relationship of bevacizumab. However, no randomized prospective study has been performed and published to evaluate the efficacy in this indication. A total of 24 patients will be randomized versus placebo in a multicenter phase III trial. The Avastin or placebo will be infused at 5mg/kg every 14 days with a total of 6 cures with a 3 months following period.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03227263
Study type Interventional
Source Hospices Civils de Lyon
Contact
Status Completed
Phase Phase 3
Start date September 28, 2017
Completion date May 15, 2020

See also
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Completed NCT01507480 - The ELLIPSE Study: A Phase-1 Study Evaluating the Tolerance of Bevacizumab Nasal Spray to Treat Epistaxis in Hereditary Hemorrhagic Telangiectasia Phase 1
Completed NCT03910244 - Pomalidomide for the Treatment of Bleeding in HHT Phase 2
Completed NCT04108052 - Diagnostic Value of Ultra-low Dose Thoracic Scanner for the Pulmonary Arteriovenous Malformation Detection in HHT Patient N/A
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Recruiting NCT00230620 - Molecular Studies on Hereditary Haemorrhagic Telangiectasia Families
Recruiting NCT02157987 - Treatment of Hereditary Hemorrhagic Telangiectasia of the Nasal Mucosa by Intranasal Bevacizumab : Search for Effective Dose Phase 1/Phase 2
Completed NCT01408030 - North American Study of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Phase 2
Completed NCT00230659 - Investigation of Coagulation Parameters in Hereditary Haemorrhagic Telangiectasia
Withdrawn NCT00733629 - Study of Endothelial Cells in Patients With Hereditary Haemorrhagic Telangiectasia
Active, not recruiting NCT00230633 - Studies of White Blood Cells Derived From HHT Patients
Recruiting NCT05933330 - Hereditary Hemorrhagic Telangiectasia and Neurovascular Manifestations, in the Danish HHT Database