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    Summary
    EudraCT Number:2014-003671-30
    Sponsor's Protocol Code Number:VHL-HOPE-2014-1
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-09-22
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2014-003671-30
    A.3Full title of the trial
    Therapeutic effect of propranolol in a series of patients with von Hippel-Lindau disease and retinal hemangioblastomas in short, medium and long term treatment.
    Efecto terapéutico de propranolol en una serie de pacientes con enfermedad de von Hippel-Lindau y hemangioblastomas de retina a corto, medio y largo plazo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of propranolol in the retinal tumours of patients with von Hippel-Lindau disease
    Efecto de propranolol en los tumores de retina de pacientes con la enfermedad de von Hippel-Lindau
    A.4.1Sponsor's protocol code numberVHL-HOPE-2014-1
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorALIANZA ESPAÑOLA DE FAMILIAS DE VON HIPPEL-LINDAU
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportALIANZA ESPAÑOLA DE FAMILIAS DE VON HIPPEL-LINDAU
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationALIANZA ESPAÑOLA DE FAMILIAS DE VON HIPPEL-LINDAU
    B.5.2Functional name of contact pointALIANZA VHL
    B.5.3 Address:
    B.5.3.1Street AddressC/SANTA MARTA, 24
    B.5.3.2Town/ cityOLÍAS DEL REY
    B.5.3.3Post code45280
    B.5.3.4CountrySpain
    B.5.4Telephone number34607680759
    B.5.6E-mailINFO@ALIANZAVHL.ORG
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name SUMIAL 40 mg COMPRIMIDOS RECUBIERTOS CON PELICULA
    D.2.1.1.2Name of the Marketing Authorisation holderAstrazeneca Farmaceutica Spain, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROPRANOLOL
    D.3.9.1CAS number 525-66-6
    D.3.9.2Current sponsor codePROPRA
    D.3.9.3Other descriptive name1-isopropilamino-3-(1-naphtoxy)-2-pro-panol
    D.3.9.4EV Substance CodeSUB10119MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    VON HIPPEL-LINDAU DISEASE
    ENFERMEDAD DE VON HIPPEL-LINDAU
    E.1.1.1Medical condition in easily understood language
    VON HIPPEL-LINDAU DISEASE (VHL)
    ENFERMEDAD DE VON HIPPEL-LINDAU (VHL)
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    TO EVALUATE THE EFFECTIVENESS OF PROPRANOLOL IN CONTROLLING THE GROWTH OF PAPILLARY AND JUXTAPAPILLARY RETINAL HEMANGIOBLASTOMAS (HB)
    EVALUAR LA EFICACIA DE PROPRANOLOL EN EL CONTROL DEL CRECIMIENTO DE LOS HEMANGIOBLASTOMAS DE RETINA PAPILARES Y YUXTAPAPILARES
    E.2.2Secondary objectives of the trial
    TO DETERMINE IF PROPRANOLOL HAS A POSITIVE EFFECT IN CONTROLLING THE GROWTH OF CENTRAL NERVOUS SYSTEM HEMANGIOBLASTOMAS
    DETERMINAR SI PROPRANOLOL TIENE UN EFECTO POSITIVO EN EL CONTROL DE LOS HEMANGIOBLASTOMAS DEL SNC
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    BIOMARKERS LEVELS IN PLASMA
    NIVELES DE BIOMARCADORES EN PLASMA
    E.3Principal 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
    PACIENTES DIAGNOSTICADOS DE ENFERMEDAD DE VON HIPPEL-LINDAU Y HEMANGIOBLASTOMAS DE RETINA, QUE ADEMÁS:
    - TENGAN AL MENOS UN HB PAPILAR O YUXTAPAPILAR
    - TENGAN UN HB PERIFÉRICO, Y HAYAN RECHAZADO LOS TRATAMIENTOS INVASIVOS HABITUALES
    E.4Principal exclusion criteria
    CONTRAINDICATIONS TO TAKE PROPRANOLOL
    CONTRAINDICACIONES PARA EL USO DE PROPRANOLOL SEGÚN LA FICHA TÉCNICA
    E.5 End points
    E.5.1Primary end point(s)
    NUMBER AND SIZE OF THE RETINAL HEMANGIOBLASTOMAS
    NÚMERO Y TAMAÑO DE LOS HEMANGIOBLASTOMAS DE RETINA A LA FINALIZACIÓN DEL ESTUDIO
    E.5.1.1Timepoint(s) of evaluation of this end point
    EVALUATION AT 1-3-6-9-12 MONTHS
    VISITAS DE EVALUACIÓN A LOS MESES 1-3-6-9 Y 12 (FINALIZACIÓN)
    E.5.2Secondary end point(s)
    NUMBER AND SIZE OF THE CENTRAL NERVOUS SYSTEM HEMANGIOBLASTOMAS
    NÚMERO Y TAMAÑO DE LOS HEMANGIOBLASTOMAS DEL SNC
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 MONTHS SINCE THE START OF TREATMENT
    12 MESES DESDE EL INICIO DEL TRATAMIENTO
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS - ÚLTIMA VISITA DEL ÚLTIMO PACIENTE
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    PATIENTS WITH VON HIPPEL-LINDAU DISEASE (INCURABLE AND SEVERE DISEASE, WITH RISK OF BLINDNESS)
    PACIENTES CON VHL, ENFERMEDAD GRAVE E INCURABLE, CON RIESGO DE CEGUERA
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    IF TREATMENT SHOWS EFFECTIVINESS, IF PROVES EFFECTIVE TREATMENT, THE IP SHOULD PROPOSE AN EXTENSION OF THE ORIGINAL STUDY
    SI EL TRATAMIENTO DEMUESTRA EFECTIVIDAD, SE PLANTEARÍA REALIZAR UN ESTUDIO DE EXTENSIÓN
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
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