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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2010-020545-26-IT
• Date of registration: 10/09/2010
• Prospective Registration: No
• Primary sponsor: AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 09/12/2008
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-020545-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: - same IMP used at different dosage

Countries of recruitment

Italy

Key inclusion & exclusion criteria

Inclusion criteria:
? 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

Exclusion criteria:
? 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT)
MedDRA version: 9.1 Level: SOC Classification code 10005329

Intervention(s)

Trade Name: AVASTIN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Trade Name: AVASTIN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Trade Name: AVASTIN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Primary end point(s): hemoglobulin concentration,evolution of pulmonary and hepatic fistulas, cardiovascular parameters (arterial blood pressure, cardiac output, right and left teledyastolic volume)

Secondary Objective: ? To assess the increase of the hemoglobulin concentration (Hb, MCH, MCHC) in the blood of HHT patients during and after the administration of bevacizumab, and the eventual necessity of transfusions. ? To monitor the evolution of pulmonary and hepatic fistulas with non-invasive procedures of proven accuracy in HHT patients during and after the period of bevacizumab administration. ? To monitor the alterations of cardiovascular parameters (arterial blood pressure, cardiac output, right and left teledyastolic volume) by means of echocardiography of HHT patients during and after administration of bevacizumab therapy.

Main Objective: ? To evaluate the efficacy of bevacizumab for treatment of severe chronic nasal and/or gastrointestinal bleeding in HHT patients. ? To establish the most effective dosage, according to a risk/benefit ratio.

Secondary ID(s)

HHT-BA0801