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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   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).

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    Summary
    EudraCT Number:2007-001326-26
    Sponsor's Protocol Code Number:AA-GYN-001
    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:2007-06-11
    Trial results View 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 number2007-001326-26
    A.3Full title of the trial
    Estudio prospectivo, controlado, aleatorizado, multicéntrico, de fase I/II para evaluar la seguridad y la eficacia de Adhexil™
    A.3.2Name or abbreviated title of the trial where available
    Uso de Adhexil en la prevención y / o reducción de adherencias después cirugía de los ovarios
    A.4.1Sponsor's protocol code numberAA-GYN-001
    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 SponsorOmrix Biopharmaceuticals Ltd.
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Quixil
    D.2.1.1.2Name of the Marketing Authorisation holderOmrix Biopharmaceuticals
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameADHEXIL
    D.3.4Pharmaceutical form Sealant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraabdominal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameTROMBINA HUMANA
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number800 to 1200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameFibrinogena Humana
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number40 to 60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 que hayan sufrido una cirugia que afectara a los ovarios
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10033137
    E.1.2Term Ovarian cystectomy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo es evaluar la seguridad y eficacia inicial del equipo anti-adherencias de Omrix, Adhexil™ , en la prevención y / o reducción de adherencias post-quirúrgicas en pacientes que hayan sufrido una cirugía que afectara a los ovarios.
    E.2.2Secondary objectives of the trial
    No hay otros objectivos con este estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes femeninas de edades entre 18 y 45 años en el momento del cribado
    2. Pacientes que van a sufrir cirugía laparoscópica electiva debida a enfermedad ovárica bilateral conocida o presunta.
    3. Las pacientes deben estar dispuestas a participar en el estudio y dar su consentimiento informado por escrito.
    4. Las pacientes deben estar disponibles y dispuestas a realizar visitas y procedimientos de estudio
    5. Las pacientes con potencial de procrear deben utilizar un método aceptable médicamente de control de natalidad durante todo el estudio.
    6. Las pacientes deben tener ambos ovarios y ambas trompas de Falopio intactas

    Criterios intraquirúrgicos de inclusión
    1. Superficie rugosa bilateral que abarque al menos 1 cm2 de superficie ovárica en cada ovario al final de la cirugía.
    E.4Principal exclusion criteria
    1. Pacientes embarazadas (incluyendo embarazos ectópicos) o que estén dando el pecho
    2. Pacientes cuyo procedimiento laparoscópico de “first look” implicaría enteretomía y / o cistotomía y / o urostomía y / o hidrotubación postoquirúrgica
    3. Pacientes cuyo procedimiento laparoscópico de “first look” implicaría esterilización quirúrgica
    4. Pacientes cuyo procedimiento laparoscópico de “first look” implicaría histerectomía
    5. Pacientes con un diagnóstico documentado de cáncer
    6. Pacientes con algún trastorno linfático, hematológico o de coagulación
    7. Pacientes con una hipersensibilidad conocida o presunta a la sangre, productos sanguíneos o cualquier constituyente de Adhexil™
    8. Pacientes cuyos valores de laboratorio pre-quirúrgicos en la visita inicial estén fuera de los rangos normales
    9. Pacientes que presenten riesgos inmunológicos, tengan alteraciones auto-inmunológicas o que normalmente tomen anticoagulantes.
    10. Pacientes que hayan participado en otro estudio clínico en los 30 días anteriores a la inscripción
    11. Opinión del investigador de que la paciente no es apropiada médicamente o estaría bajo riesgo importante si se inscribiera en el estudio.
    12. Pacientes en la clase > I de la Sociedad americana de anestesistas

    Criterios intraquirúrgicos de exclusión
    1. Incapacidad para disolver alguna de las adherencias ováricas existentes
    2. Ausencia de uno o ambos ovarios
    3. Ausencia de una o ambas trompas de Falopio
    4. Presencia de infección activa.
    5. Presencia de algún proceso maligno
    6. Uso de irrigantes que contengan heparina
    7. Uso de otros coadyuvantes con el propósito de reducir adherencias, incluyendo INTERCEED, SprayGel, Seprafilm, ADEPT, Hyskon, Oxiplex, corticosteroides, anticoagulantes y agentes anti-inflamatorios no esteroidales.
    8. Necesidad de realizar enteretomía y / o cistotomía y / o urostomía y / o histerectomía
    9. Pacientes que han sufrido un procedimiento de injerto peritoneal
    10. Pacientes en quienes se requiere un procedimiento para la conversión a laparotomía
    11. El uso de cualquier agente hemostático tópico que permanezca en el cuerpo, o el uso de catgut, catgut crómico o suturas no reabsorbibles en los ovarios o en las estructuras inmediatamente adyacentes.
    12. Uso de laparoscopia sin gas
    13. Realización de procedimiento quirúrgico no ginecológico (colecistectomía)
    14. La opinión del investigador de que a la paciente no le conviene un “second look”
    E.5 End points
    E.5.1Primary end point(s)
    El principal criterio de valoración será la incidencia de ovarios con adherencias.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    indicacion differente para un producto aprobado
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    ciego para terceros
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sitios no tratados del mismo paciente
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Cada paciente será tratado con Adhexil y se le realizará un seguimiento de seguridad y evaluaciones de eficacia durante un periodo de 6 (+/- 4) semanas después de la cirugía (en casos excepcionales se llegará a un máximo de 14 semanas después de la laparoscopia de “first look”). Basándose en un periodo de control de hasta 3 semanas y un periodo de seguimiento de un máximo de 18 semanas, cada paciente estará en el estudio durante no más de 21 semanas.
    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 months9
    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 months9
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 25
    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)
    Tras un mínimo de 30 días de la segunda laparoscopia (+ 2 días) se realizará una visita de seguimiento por teléfono y la paciente será preguntada por su estado físico y por cualquier cambio de medicaciones concomitantes y cualquier acontecimiento adverso desde la última visita. La información serán recogida en la hoja de trabajo y en el CRF.
    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 Decision2007-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-09-30
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