BEVACIZUMAB, AN ANTI-ANGIOGENIC MONOCLONAL ANTIBODY EFFECTIVE FOR PREVENTION OF HEMORRHAGING IN PATIENTS WITH HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT): POSSIBLE REGRESSION OF VISCERAL ARTERIOVENOUS MALFORMATIONS - ND
- Conditions
- HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT)MedDRA version: 9.1Level: SOCClassification code 10005329
- Registration Number
- EUCTR2010-020545-26-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
? Patients diagnosed with HHT, in particular HHT2, for whom the severity of this disease presents a life-damaging risk ? Adult volunteer patients, in possession of full mental capacity ? Patients with frequent and long-lasting epistaxis episodes ? Patients with untreatable gastrointestinal bleeding ? Patients with hemoglobin values < 9 g/dl ? Patients between the ages of 18 and 70 years
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
? Patients with elevated risk factor for hemorrhagic diseases ? Patients with cerebral arteriovenous fistulas ? Female patients during age of fertility, during pregnancy, or breast-feeding ? Patients with severe diabetic decompensation ? Patients at elevated risk for thromboembolic disease, in particular previous episodes of brain stroke, deep venous thrombosis, pulmonary embolism and myocardial ischemia ? Patients diagnosed with current neoplasms ? Patients subjected to surgical procedures less than one month previously or who are shortly scheduled for surgery ? Patients with uncontrollable hypertension ? Patients with epilepsy ? Patients with proteinuria (> 2 gr/24h) ? Patients with chronic intestinal inflammatory disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method