Telangiectasia, Hereditary Hemorrhagic Clinical Trial
Official title:
Efficacy of Nintedanib Per os as a Treatment for Epistaxis in HHT Disease. A National, Randomized, Multicentre Phase II Study
The recognized manifestations of HHT are all due to abnormalities in vascular structure. Epistaxis are spontaneous, very variable, may occur as often as several times every day, and are recurrent in 90% of patients and associated with chronic and severe anemia in 2-10%. They also significantly reduce quality of life. Blood transfusions are sometimes required in 10-30% of patients. Previous studies showed that antiangiogenic treatments such as anti-VEGF treatment (bevacizumab) administered intravenously was efficient on epistaxis and dramatically reduced nosebleeds. Tyrosine kinase inhibitors are anti-angiogenic molecules which are available orally and could therefore overcome the difficulties encountered with bevacizumab. The investigator hypothesized that nintedanib, acting by indirect inhibition of the VEGF receptor should allow a reduction of epistaxis in HHT patient. Nintedanib has been used in one HHT patient following the diagnosis of Insterstitial Pulmonary Fibrosis (published case report in 2017, Kovacs et al) with encouraging results. The aim is to evaluate efficacy of nintedanib for the treatment of epistaxis in HHT patients
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03227263 -
BABH Study: Efficacy and Safety of Bevacizumab on Severe Bleedings Associated With Hemorrhagic Hereditary Telangiectasia (HHT).
|
Phase 3 | |
Completed |
NCT00733655 -
Study of Histological Samples From Patients With Hereditary Haemorrhagic Telangiectasia
|
||
Completed |
NCT00355108 -
ATERO : A Randomised Study With Tranexamic Acid in Epistaxis of Rendu Osler Syndrome
|
Phase 3 | |
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 | |
Recruiting |
NCT04976036 -
Efficacy of Nintedanib for Treatment of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) Patients
|
Phase 2 | |
Completed |
NCT00684879 -
Screening Behavior in Adults With Hereditary Hemorrhagic Telangiectasia
|
||
Completed |
NCT00004648 -
Studies of Hereditary Hemorrhagic Telangiectasia
|
N/A | |
Completed |
NCT00230672 -
Investigation of Plasma Proteins in Patients With Hereditary Haemorrhagic Telangiectasia and PAVMs
|
||
Completed |
NCT02484716 -
Efficacy of a Timolol Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) - (TEMPO)
|
Phase 2 | |
Recruiting |
NCT00230685 -
Case Notes Review on Patients With Hereditary Haemorrhagic Telangiectasia
|
||
Terminated |
NCT02204371 -
Evaluation of Pazopanib on Bleeding in Subjects With Hereditary Haemorrhagic Telangiectasia
|
Phase 2 | |
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
|