Efficacy and Safety of Bevacizumab for the Treatment Hemorrhagic Hereditary Telangiectasia (HHT) Associated With Severe Hepatic Vascular Malformations. Phase II Study (METAFORE)
|ClinicalTrials.gov Identifier: NCT00843440|
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : May 30, 2013
The efficacy of anti-VEGF treatments such as Bevacizumab in cases of HHT can be considered because of the molecular mechanisms implied in angiogenesis and HHT, as well as the mechanisms of action of this type of treatment. Two articles that have recently reported spectacular improvement thanks to Bevacizumab in patients with HHT complicated with severe liver involvement and cardiac effects support us in this sense.
Up to now, the only treatment recommended in the severe hepatic forms of HHT is a liver transplant, the disadvantages of which are both multiple and well known: long waiting lists, surgical morbidity and mortality, immunosuppressive treatment for life. Furthermore, treatment with Bevacizumab is not a contraindication, should the drug be ineffective, for a subsequent liver transplant if necessary.
|Condition or disease||Intervention/treatment||Phase|
|Hemorrhagic Hereditary Telangiectasia||Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Bevacizumab for the Treatment Hemorrhagic Hereditary Telangiectasia (HHT) Associated With Severe Hepatic Vascular Malformations. Phase II Study.|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2012|
Study using a Gehan design, 7 patients will be included in the first phase and 18 additional patients will enter the second phase.
5 mg / kg every 14 days with a total of 6 injections.A two-phase Gehan method will be used with a first phase designed to eliminate a non effective treatment quickly and a second phase allowing assessment of efficacy.
Other Name: AVASTIN
- cardiac output measured at 3 months [ Time Frame: 3 months ]
- Evaluation at 6 and 12 months [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843440
|Hospices Civils de Lyon|
|Principal Investigator:||Sophie DUPUIS-GIROD, MD||Hospices Civils de Lyon|