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    Summary
    EudraCT Number:2016-003982-24
    Sponsor's Protocol Code Number:HHT-HOPE-2016
    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:2016-12-09
    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 number2016-003982-24
    A.3Full title of the trial
    A phase IV-II, single-center, open, single arm treatment, low level of intervention, to assess the efficacy clinical trial and safety of intranasal administration of ethamsylate in the treatment of hereditary hemorrhagic telangiectasia, during 4 weeks
    Ensayo clínico de fase IV-II, unicéntrico, abierto y de un solo brazo de tratamiento, de bajo nivel de intervención, para evaluar la eficacia y la seguridad de la administración intranasal de etamsilato en el tratamiento de la telangiectasia hemorrágica hereditaria, durante 4 semanas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the efficacy clinical trial and safety of intranasal administration of ethamsylate in the treatment of hereditary hemorrhagic telangiectasia, during 4 weeks
    Estudio para evaluar la eficacia y la seguridad de la administración intranasal de etamsilato en el tratamiento de la telangiectasia hemorrágica hereditaria, durante 4 semanas
    A.4.1Sponsor's protocol code numberHHT-HOPE-2016
    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 SponsorAsociación HHT España
    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 supportAsociación HHT España
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAsociación HHT España
    B.5.2Functional name of contact pointBienvenido Muñoz
    B.5.3 Address:
    B.5.3.1Street AddressC/Ramiro de Maeztu, 9
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number0034630904306
    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 Dicynone
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtamsylate
    D.3.9.1CAS number 2624­44­4
    D.3.9.2Current sponsor codeEtamsylate
    D.3.9.3Other descriptive nameETAMSYLATE
    D.3.9.4EV Substance CodeSUB11943MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    Hereditary hemorrhagic telangiectasia
    Telangiectasia Hemorrágica Hereditaria
    E.1.1.1Medical condition in easily understood language
    Nosebleed
    Hemorragía nasal
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10020023
    E.1.2Term HHT
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of daily administration of intranasal Ethamsylate in improving the HHT at 4 weeks of starting treatment, by measuring the number of epistaxis per week and features.
    Evaluar la eficacia de la administración diaria intranasal de etamsilato en la mejora de la HHT a las 4 semanas de iniciar el tratamiento, mediante la medición del número de epistaxis por semana y sus características.
    E.2.2Secondary objectives of the trial
    • Evaluate the effect of daily intranasal administration of Ethamsylate to reverse anemia (Hb, hematocrit, reticulocytes, erythropoietin, etc.) associated with HHT, at 4 weeks of starting treatment.
    • To evaluate the incidence of adverse events according to their severity, severity, relationship to treatment with intranasal Ethamsylate during 4 weeks of treatment, and the effect on the quality of life of patients.
    • Evaluar el efecto de la administración diaria intranasal de etamsilato para revertir la anemia (Hb, hematocrito, reticulocitos, eritropoyetina, etc.) asociada a la HHT, a las 4 semanas de iniciar el tratamiento.
    • Evaluar la incidencia de acontecimientos adversos según su severidad, gravedad, relación con el tratamiento con etamsilato intranasal durante 4 semanas de tratamiento, así como el efecto sobre la calidad de vida del paciente.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Adult patients (18 years or more) of both sexes.
    • Diagnosis of HHT.
    • High propensity for nosebleeds
    • Patients with ability and willingness to follow the study protocol and give their informed consent (signed and dated), agreeing to participate voluntarily in the study.
    • Pacientes adultos (18 años o más) de ambos sexos.
    • Diagnóstico de HHT.
    • Alta propensión a la hemorragia nasal
    • Pacientes con capacidad y voluntad para seguir el protocolo del estudio y que otorguen su consentimiento informado (fechado y firmado), aceptando participar voluntariamente en el estudio.
    E.4Principal exclusion criteria
    • Do not sign the informed to participate in the study after being informed by the investigator on the target, the course and potential risks of the study consent.
    • Patients who can not meet the requirements of the study or in the investigator's opinion should not participate in the study.
    • Patients with concomitant diseases, according to the researcher may influence (by the disease itself and / or its treatment) in the development, evolution or valuation of HHT.
    • Patients who have received anti-inflammatory treatment in the last month.
    • Patients in whom the use of Ethamsylate is contraindicated.
    • Pregnant or breast-feeding.
    • No firmar el consentimiento informado para su participación en el estudio tras haber sido informado por el investigador sobre el objetivo, el transcurso y los posibles riesgos del estudio.
    • Pacientes que no pueden cumplir con los requisitos del estudio o que en opinión del investigador no deben participar en el estudio.
    • Pacientes con enfermedades concomitantes que, a juicio del investigador puedan influir (por la enfermedad en sí y/o sus tratamientos) en el desarrollo, evolución o valoración de la HHT.
    • Pacientes que hayan recibido tratamiento antiinflamatorio en el último mes.
    • Pacientes en los que esté contraindicado el uso de etamsilato.
    • Mujeres embarazadas o en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    •number of epistaxis per week
    •bleeding time
    •amount of bleeding
    •evolution of anemia
    •número de epistaxis por semana
    •tiempo de sangrado
    •cantidad de sangrado
    •evolución de la anemia
    E.5.1.1Timepoint(s) of evaluation of this end point
    •endoscopic image of the nasal mucosa telangiectasia
    •overall evaluation of study treatment
    •assessment of quality of life
    4 weeks
    E.5.2Secondary end point(s)
    4 semanas
    •imagen rinoscópica de las telangiectasias en mucosa nasal
    •evaluación global del tratamiento del estudio
    •evaluación de la calidad de vida
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 weeks
    4 semanas
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    Ultima visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 12
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    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)
    None
    Ninguno
    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 Decision2017-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-02
    P. End of Trial
    P.End of Trial StatusCompleted
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