The use of systemic propranolol in congenital hemangiomas - CDO0901
- Conditions
- congenital hemangiomasMedDRA version: 12.1Level: LLTClassification code 10018818Term: Haemangioma congenital
- Registration Number
- EUCTR2009-014571-49-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients > 4 weeks of age and < 12 months of age, with one of the following features: - Large congenital hemangioma - Hemangioma in a critical site - Both the conditions above mentioned - Patients whose parents have signed a informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- Hypersensitivity to propranolol in first degree relatives - Severe clinical conditions that contraindicate the inclusion in the study - Mellitus diabetes
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to evaluate the efficacy of systemic propranolol in the treatment of congenital hemangiomas, during the first months of life.;Secondary Objective: The secondary objective is to evaluate the tolerability of systemic propranolol in the treatment of congenital hemangiomas, during the first months of life;Primary end point(s): Evaluation of the efficacy of systemic propranolol in the treatment of congenital hemangiomas, during the first months of life
- Secondary Outcome Measures
Name Time Method