Effect of propranolol in the retinal tumours of patients with von Hippel-Lindau disease
Phase 1
- Conditions
- VON HIPPEL-LINDAU DISEASETherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2014-003671-30-ES
- Lead Sponsor
- ALIANZA ESPAÑOLA DE FAMILIAS DE VON HIPPEL-LINDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
PATIENTS DIAGNOSED OF VON HIPPEL-LINDAU DISEASE AND RETINAL HEMANGIOBLASTOMAS, THAT IN ADDITION:
- AT LEAST ONE PAPILLARY OR JUXTAPAPILLARY HB, OR
- PERIPHERICAL HB, WHO HAD REJECTED ANOTHER TREATMENTS
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 9
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
CONTRAINDICATIONS TO TAKE PROPRANOLOL
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: TO EVALUATE THE EFFECTIVENESS OF PROPRANOLOL IN CONTROLLING THE GROWTH OF PAPILLARY AND JUXTAPAPILLARY RETINAL HEMANGIOBLASTOMAS (HB);Secondary Objective: TO DETERMINE IF PROPRANOLOL HAS A POSITIVE EFFECT IN CONTROLLING THE GROWTH OF CENTRAL NERVOUS SYSTEM HEMANGIOBLASTOMAS;Primary end point(s): NUMBER AND SIZE OF THE RETINAL HEMANGIOBLASTOMAS;Timepoint(s) of evaluation of this end point: EVALUATION AT 1-3-6-9-12 MONTHS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NUMBER AND SIZE OF THE CENTRAL NERVOUS SYSTEM HEMANGIOBLASTOMAS;Timepoint(s) of evaluation of this end point: 12 MONTHS SINCE THE START OF TREATMENT