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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43977   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    Summary
    EudraCT Number:2007-002237-37
    Sponsor's Protocol Code Number:CONHEMO-2006
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-08-08
    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 number2007-002237-37
    A.3Full title of the trial
    TRATAMIENTO GUIADO SEGÚN RESPUESTA HEMODINÁMICA, PARA LA PREVENCIÓN DE RECIDIVA HEMORRÁGICA POR VARICES ESOFÁGICAS. ESTUDIO CONTROLADO Y ALEATORIZADO, FASE IV.
    A.3.2Name or abbreviated title of the trial where available
    CONHEMO-2006
    A.4.1Sponsor's protocol code numberCONHEMO-2006
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut de Recerca del Hopsital de la Santa Creu i Sant Pau
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Solgol
    D.2.1.1.2Name of the Marketing Authorisation holderSANOFI AVENTIS, 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 Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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 Coronur
    D.2.1.1.2Name of the Marketing Authorisation holderKERN PHARMA, S.L.
    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 Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 3
    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 MINIPRES
    D.2.1.1.2Name of the Marketing Authorisation holderNOSTRUM FARMA, 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 Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Pacientes de ambos sexos, con cirrosis hepática, con edad superior a 18 años, que hayan presentado un episodio de hemorragia por varices esofágicas.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009211
    E.1.2Term Cirrhosis liver
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10055489
    E.1.2Term Esophageal varices in cirrhosis of liver
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar si la terapia guiada según respuesta hemodinámica en pacientes cirróticos que han presentado un episodio de hemorragia por varices esofágicas, mejora la supervivencia observada con el tratamiento de elección en la actualidad. Para ello un grupo control recibirá tratamiento con ligadura endoscópica + Solgol + Coronur, y un grupo experimental recibirá tratamiento con Ligadura y Fármacos según respuesta hemodinámica (inicialmente Solgol, si no respuesta (estudio agudo) Solgol + Coronur, y si no respuesta (estudio crónico) Solgol + Minipres).
    E.2.2Secondary objectives of the trial
    Establecer el efecto de la la terapia guiada según respuesta hemodinámica, en pacientes cirróticos que han presentado un episodio de hemorragia variceal sobre:
    a) recidiva hemorrágica por varices esofágicas
    b) recidiva por otras causas relacionadas con la hipertensión portal (varices gástricas, gastropatía de la hipertensión portal, úlceras esofágicas por LEV).
    c) muertes por hemorragia
    d) muertes por hemorragia por varices
    e) requerimiento de transplante hepático
    f) tasa de efectos secundarios
    g) tasa de efectos secundarios graves
    h) aparición de ascitis y/o trastornos de la función renal
    i) aparición de encefalopatia y evolución de la función hepática
    j) necesidades de transfusión, hospitalización y tratamientos alternativos
    k) erradicación de las varices.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    6.2.5.1.1. Serán incluidos todos los pacientes admitidos en urgencias en los que 1) se constate la existencia de hemorragia digestiva por la presencia de melenas y/o hematemesis, y 2) se diagnostique que esta es debida a varices esofágicas.
    6.2.5.1.2. Se definirá hemorragia por varices esofágicas al hallar en la FGC alguno de los siguientes signos: 1) sangrado activo en jet o en sabana, 2) coagulo adherido sobre las VE o clavo plaquetar, junto con restos hematicos recientes en la luz esofagogástrica, o 3) varices esofágicas junto con sangre roja en la luz esofagogástrica en ausencia de otras lesiones en la exploración endoscópica alta completa.
    6.2.5.1.3. Las hemorragias debidas a varices cardiales, intraherniarias y gastricas subcardiales (prolongación de las esofágicas) serán igualmente incluidas.
    6.2.5.1.4. criterios clínicos y/o analíticos, ecográficos y/o biopsia hepática compatibles con el diagnóstico de cirrosis hepática.
    6.2.5.1.5. Consentimiento informado por escrito para participar en el estudio.
    6.2.5.1.6. Las pacientes en edad fértil deben utilizar métodos de barrera para la prevención del embarazo durante la totalidad del estudio. La prueba de embarazo previa al estudio debe ser negativa
    E.4Principal exclusion criteria
    Uno o más de los siguientes:
    6.2.5.2.1. Edad <18 o >80 años.
    6.2.5.2.2. Decisión de no terapéutica activa en función de las caracteristicas del paciente (terminales). Se incluirán en aquí aquellos pacientes con insufiencia hepática avanzada, considerando como tal una puntuación de 13 o más puntos en la escala de Child-Pugh. También se incluirán en este punto aquellos pacientes con enfermedades asociadas con un pronóstico estimado de vida inferior a 6 meses.
    6.2.5.2.3. No consentimiento por parte de el paciente.
    6.2.5.2.4. Hemorragia debida a causas diferentes a las varices esofágicas, según el diagnóstico endoscópico. Tampoco se incluirán las hemorragias por gastropatia hipertensiva ni las debidas a varices gástricas fúndicas.
    6.2.5.2.5. Inclusión previa en este mismo protocolo.
    6.2.5.2.6. Fracaso del tratamiento médico para el control del episodio indice de hemorragia.
    6.2.5.2.7. Tratamiento previo mediante programa electivo de LEV, escleroterapia o medinante terapéutica farmacológica combinada con β-bloqueantes y nitratos, o ser portador de una derivación portosistémica (quirúrgica o percutánea).
    6.2.5.2.8. Contraindicación para β-bloqueantes y para MNI (no se excluirán los pacientes con contraindicación para uno solo de estos fármacos) o para procedimientos endoscópicos.
    6.2.5.2.9. Embarazo.
    6.2.5.2.10. Presencia de carcinoma hepatocelular multinodular o único con un diámetro superior a 5 cm
    E.5 End points
    E.5.1Primary end point(s)
    Principal: Para la evaluación de la mortalidad se incluirán todos los fallecimientos ocurridos durante el periodo de estudio, sea debida a recidiva hemorrágica o a otras causas. Se considerán relacionados con recidiva los episodios que ocurran dentro de los 30 dias siguientes a un episodio hemorrágico.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    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 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) No
    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 Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    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 Decision2008-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-08-01
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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