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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:2006-005940-99
    Sponsor's Protocol Code Number:PERICO
    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:2012-09-12
    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 number2006-005940-99
    A.3Full title of the trial
    Open, multicentral and randomized study of phase IV to evaluate efficacy and safety to extent of treatment with Peginterferon alpha-2a (40 KD) combined with high doses of Ribavirin with support of Epoetina beta for chronic hepatitis C in patients co infected with HIV with not undetectable HCV-RNA at week 4 on treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Estudio abierto, multicéntrico y aleatorizado de fase IV para evaluar la eficacia y seguridad de prolongar la duración del tratamiento con Interferón Pegilado alfa-2a (40 KD) asociado a dosis altas de Ribavirina con apoyo de Epoetina ?, en el tratamiento de la hepatitis C crónica de pacientes coinfectados por el virus de la inmunodeficiencia humana que no consiguen negativizar el virus en sangre en la semana 4 de tratamiento.
    A.3.2Name or abbreviated title of the trial where available
    PERICO
    A.4.1Sponsor's protocol code numberPERICO
    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 Sponsorvicente soriano
    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 supportHospital Carlos III
    B.4.2CountrySpain
    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 pointBeatriz Navarro
    B.5.3 Address:
    B.5.3.1Street AddressC/ Yerma, 10-5ºD
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034661 75 21 63
    B.5.5Fax number003491744 10 37
    B.5.6E-mailbeatriznavar@gmail.com
    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 PEGASYS (PEGINTERFERON ALFA 2A)
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE PHARMA SA
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON ALFA-2A
    D.3.9.1CAS number 198153-51-4
    D.3.9.2Current sponsor codeRo 025-8310
    D.3.9.3Other descriptive nameinterferón pegilado alfa-2a
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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.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 COPEGUS (RIBAVIRINA)
    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 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 INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.9.2Current sponsor codeRo 020-9963
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    hepatitis C in patients co infected with HIV
    E.1.1.1Medical condition in easily understood language
    hepatitis c en pacientes VIH positivo
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    ?Comparar la Repuesta Virológica Sostenida (RVS = ARN-VHC indetectable 24 semanas tras finalizar el tratamiento) de los pacientes con hepatitis C crónica genotipos 1-4 coinfectados por el VIH, tratados con Peginterferón alfa-2a (40 KD) 180 µg/semana y Ribavirina (2000 mg/día durante 4 semanas, seguido de 1000-1200 mg/día, según peso); frente a Peginterferón alfa-2a (40 KD) 180 ?g/semana y Ribavirina (1000-1200 mg/día, según peso).
    ?Evaluar el impacto en la RVS de prolongar el tratamiento con Peginterferón alfa-2a y Ribavirina hasta 72 semanas, en aquellos pacientes con genotipos 1-4 que no consiguen Respuesta Virológica Rápida (RVR = ARN-VHC indetectable en semana 4).
    E.2.2Secondary objectives of the trial
    ?Comparar la proporción de pacientes que logran RVR entre ambos brazos de tratamiento, tanto en genotipos 1-4 como en genotipos 2-3.
    ?Analizar el impacto en la RVS de prolongar el tratamiento en genotipos 1-4 sin RVR, y de acortar el tratamiento en genotipos 2-3 con RVR.
    ?Comparar la seguridad de ambos brazos de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ?Varones y mujeres de ?18 años.
    ?Evidencia serológica de infección por hepatitis crónica C (HCC) en una prueba de anticuerpos anti-VHC.
    ?Nivel plasmático de ARN-VHC detectable.
    ?Evidencia serológica de infección por VIH-1: ELISA y Western-blot.
    ?Pacientes con recuento de células CD4 ?250 cel/mm3.
    ?Estado estable de la infección por VIH-1, en opinión del investigador, es decir, pacientes que no se espera que experimenten progresión durante el estudio.
    ?No haber recibido previamente tratamiento para la hepatitis C con cualquier tipo de interferón, con o sin Ribavirina.
    ?Pacientes tratados con terapia antirretroviral (HAART) estable durante, al menos, 6 semanas antes de la evaluación basal, en los que no se prevea modificar el régimen HAART (fármacos y dosis) durante, al menos, las 6 primeras semanas del estudio.
    ?Pacientes que no reciban terapia HAART y no esté previsto iniciarla durante, al menos, 6 semanas después de iniciar el estudio.
    ?En el caso de las mujeres potencialmente fértiles, prueba de embarazo negativa (en orina o en sangre) documentada durante las 24 horas previas a la administración de la primera dosis de la medicación del estudio. Se informará tanto a varones como a mujeres fértiles sobre la necesidad de evitar embarazo durante el periodo de tratamiento y hasta 6 meses después, por el riesgo de teratogenia asociado a la medicación utilizada.
    ?Consentimiento informado firmado y fechado por escrito.
    E.4Principal exclusion criteria
    ?Mujeres embarazadas o en período de lactancia.
    ?Pacientes cuya pareja tenga expectativas de embarazo.
    ?Pacientes que hayan recibido en algún momento terapia con Interferón o Ribavirina.
    ?Pacientes con Child-Pugh > 6 (estadio B o C)
    ?Antecedentes o signos de enfermedad hepática descompensada.
    ?Haber recibido cualquier fármaco experimental en las 6 semanas previas a la primera dosis de la medicación del estudio. (NOTA: Se permiten los pacientes incluidos en programas de acceso expandido para el tratamiento del VIH).
    ?Pacientes que estén recibiendo zidovudina (contraindicación relativa) y/o didanosina (contraindicación absoluta)
    ?Alguna de las siguientes pruebas serológicas positivas en la fase de selección: Ac anti-VHA IgM, Ag HBs, Ac anti-HBc IgM, Ag HBe.
    ?Historia u otros indicios de condiciones médicas asociadas con enfermedad hepática crónica, que no sea por VHC (ej. hemocromatosis, hepatitis autoinmune, enfermedad alcohólica hepática, exposición a toxinas).
    ?Concentraciones séricas de ceruloplasmina o ?1-antitripsina en la fase de selección, consistentes con un aumento del riesgo de desarrollar hepatopatía metabólica.
    ?Sospecha documentada por ecografía de hepatocarcinoma.
    ?Infección oportunista activa y/o neoplasia relacionada con VIH que requieran terapia aguda sistémica en el momento de la inclusión.
    ?Recuento absoluto de neutrófilos <1500 células/mm3.
    ?Niveles de hemoglobina <11 g/dl en mujeres o 12 g/dl en varones o cualquier paciente en el que la anemia sería clínicamente problemática.
    ?Hemoglobinopatía (ej. talasemia) o cualquier otra causa o tendencia a hemólisis.
    ?Recuento de plaquetas <50.000 células/mm3.
    ?El uso durante los 3 meses previos de factores estimuladores del crecimiento de colonias como G-CSF (Neupogen), GM-CSG (Sargramostim), eritropoyetina (Epotin alfa) u otros agentes terapéuticos que aumenten los parámetros hematológicos de laboratorio para facilitar la entrada del paciente en el estudio.
    ?Nivel de creatinina sérica >1,5 veces el límite superior de normalidad en la fase de selección.
    ?Historia de enfermedad psiquiátrica severa, especialmente depresión. La enfermedad psiquiátrica severa se define como la necesidad, por parte del pacientes durante al menos 3 meses, de tratamiento con medicación antidepresiva o un tranquilizante mayor a dosis terapéuticas, para el tratamiento de depresión o psicosis grave; o antecedentes de: intento de suicidio, hospitalización por enfermedad psiquiátrica, período de discapacidad debido a enfermedad psiquiátrica.
    ?Historia de trastornos convulsivos severos o uso de anticonvulsivantes en la actualidad.
    ?Historia de enfermedad de componente inmunológico (ej. enfermedad intestinal inflamatoria, púrpura trombocitopénica idiopática, lupus eritematoso, anemia hemolítica autoinmune, esclerodermia, psoriasis severa, artritis reumatoide, crioglobulinemia).
    ?Historia u otros indicios de enfermedad pulmonar crónica asociada con limitación funcional.
    ?Historia de enfermedad cardiaca significativa que podría empeorar por anemia aguda (Clase funcional III o IV de la NYHA, infarto de miocardio durante los 6 meses anteriores, taquiarritmias ventriculares que requieren tratamiento en curso, angina inestable).
    ?Historia de enfermedad tiroidea mal controlada con las medicaciones prescritas. Se excluyen los pacientes con concentraciones elevadas de la hormona tiroideoestimulante (TSH), con aumento de los anticuerpos contra la peroxidasa tiroidea y cualquier manifestación clínica de enfermedad tiroidea.
    ?Indicios de retinopatía severa (ej. retinitis por CMV, degeneración macular).
    ?Historia de trasplante de órganos vitales con injerto funcional existente.
    ?Historia u otros indicios de enfermedad severa, neoplasia o cualquier otra condición que, en opinión del investigador, haría que el paciente no fuese apropiado para participar en el estudio.
    ?Historia de cualquier tratamiento antineoplásico o inmunomodulador sistémico (incluyendo dosis suprafisiológicas de esteroides y radiación) en los 6 meses previos a la primera dosis de la medicación del estudio o expectativas de que dicho tratamiento será necesario en cualquier momento durante el estudio.
    ?Tratamiento concomitante con rifampicina, rifabutina, pirazinamida, isoniazida, ganciclovir, talidomida, oximetolona (Anadrol®) y agentes antivirales sistémicos como terapia adyuvante para HCC.
    ?Evidencia de consumo excesivo de alcohol y/o drogas o uso de sustancias en los últimos 6 meses antes de la primera dosis que, a juicio del investigador pudiera resultar que el paciente no fuera fiable para cumplir con las condiciones del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    - To compare sustained virological response (SVR= undetectable HCV-RNA after 24 weeks of treatment-free follow-up) in co-infected patients with HCV/HIV genotypes 1-4 on treatment with Peginterferon alpha-2a (40 KD) 180 ?g/week combined with Ribavirin (2000 mg/day during 4 weeks, after 1000-1200 mg/day depends on weight) in front of Peginterferon alpha-2a (40 KD) 180 ?g/week and Ribavirin 1000-1200 mg/day depends on weight
    - To evaluate impact in SVR to extent of treatment with Peginterferon alpha-2a and Ribavirin during 72 weeks in patients genotypes 1-4 with not rapid virological response (RVR=undetectable HCV-RNA at week 4
    ? Comparar la Repuesta Virológica Sostenida (RVS = ARN-VHC indetectable 24 semanas tras finalizar el tratamiento) de los pacientes con hepatitis C crónica genotipos 1-4 coinfectados por el VIH, tratados con Peginterferón alfa-2a (40 KD) 180 µg/semana y Ribavirina (2000 mg/día durante 4 semanas, seguido de 1000-1200 mg/día, según peso); frente a Peginterferón alfa-2a (40 KD) 180 ?g/semana y Ribavirina (1000-1200 mg/día, según peso).
    ? Evaluar el impacto en la RVS de prolongar el tratamiento con Peginterferón alfa-2a y Ribavirina hasta 72 semanas, en aquellos pacientes con genotipos 1-4 que no consiguen Respuesta Virológica Rápida (RVR = ARN-VHC indetectable en semana 4).
    E.5.1.1Timepoint(s) of evaluation of this end point
    February 2007-November 2010, include a recruitment period of 23 months
    Febrero 2007 - Noviembre 2010, incluyendo un periodo de inclusión de 23 meses.
    E.5.2Secondary end point(s)
    - To compare percentage of patients with RVR between both arms of treatment, in genotypes 1-4 and genotypes 2-3.
    - To evaluate impact in SVR to extent of treatment in genotypes 1-4 without RVR and to reduce the time of treatment in genotypes 2-3 with RVR
    - To compare the safety between both arms of treatment.
    ? Comparar la proporción de pacientes que logran RVR entre ambos brazos de tratamiento, tanto en genotipos 1-4 como en genotipos 2-3.
    ? Analizar el impacto en la RVS de prolongar el tratamiento en genotipos 1-4 sin RVR, y de acortar el tratamiento en genotipos 2-3 con RVR.
    ? Comparar la seguridad de ambos brazos de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    February 2007-November 2010, include a recruitment period of 23 months
    Febrero 2007 - Noviembre 2010, incluyendo un periodo de inclusión de 23 meses
    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) No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned40
    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 Yes
    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
    última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 384
    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 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state384
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 384
    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)
    Patients will be evaluated during 24 weeks after to complete the treatment for evaluate SVR.
    Patients without early virological response (EVR= undetectable HCV-RNA or not decrease of ? 2 log at week 12) or undetectable HCV-RNA at week 24 drop out of study
    Los pacientes se seguirán durante 24 semanas después de finalizar el tratamiento para evaluar RVS.
    Los pacientes que no hayan conseguido Respuesta Virológica Precoz (RVP = ARN-VHC indetectable o una disminución de > 2 log10 en semana 12) o viremia indetectable en semana 24 abandonarán el estudio.
    Los pacientes que por cualquier motivo hayan tenido que suspender el tratamiento serán seguidos durante 24 semanas, para valorar parámetros de eficacia y seguridad.
    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 Decision2007-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-30
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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