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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   42314   clinical trials with a EudraCT protocol, of which   6969   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:2011-004928-35
    Sponsor's Protocol Code Number:VX-950HPC3008
    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:2012-01-27
    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 number2011-004928-35
    A.3Full title of the trial
    Open-Label, Phase 3b Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Virus Treatment-Naïve and Treatment-Experienced Subjects with Genotype 1 Chronic Hepatitis C and Human Immunodeficiency Virus Type 1 (HCV-1/HIV-1) Coinfection
    Estudio en fase 3b abierto para determinar la eficacia y la seguridad de telaprevir, interferón-alfa-2a pegilado y ribavirina en sujetos con coinfección por el virus de la hepatitis C crónica de genotipo 1 y el virus de la inmunodeficiencia humana de tipo 1 (VHC-1/VIH-1), con y sin tratamiento previo para el virus de la hepatitis C
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of Telaprevir in Patients Infected With Both Chronic HCV-1 and HIV-1
    Estudio de Eficacia y seguridad de telaprevir en pacientes infectados con VHC-1 Crónica y VHI-1
    A.3.2Name or abbreviated title of the trial where available
    INSIGHT
    A.4.1Sponsor's protocol code numberVX-950HPC3008
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen-Cilag International NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV - Clinical Registry Group
    B.5.2Functional name of contact pointJanssen Biologics BV
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31071524 21 66
    B.5.5Fax number+31071524 21 10
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 INCIVO
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameINCIVO
    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.3.9.1CAS number 402957-28-2
    D.3.9.3Other descriptive nameTELAPREVIR
    D.3.9.4EV Substance CodeSUB31651
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number375
    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
    Chronic hepatitis C infection
    Infeccion Crónica por Hepatitis C
    E.1.1.1Medical condition in easily understood language
    Chronic hepatitis C infection
    Infeccion Crónica por Hepatitis C
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019752
    E.1.2Term Hepatitis C virus (HCV)
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to assess the antiviral efficacy of telaprevir, Peg-IFN-alfa-2a, and RBV in HCV-1/HIV-1 coinfected subjects as measured by sustained virologic response (SVR12planned). SVR12planned is defined as having an undetectable HCV RNA level 12 weeks after the last planned dose of study medication.
    El objetivo principal es evaluar la eficacia antiviral de telaprevir, interferón alfa-2a pegilado (Peg-IFN-alfa-2a) y ribavirina (RBV) en sujetos coinfectados por el VHC-1/VIH-1 determinada por la respuesta virológica sostenida (RVS12prevista). La RVS12prevista se define como una concentración indetectable de ácido ribonucleico (ARN) del VHC 12 semanas después de la última dosis prevista de la medicación del estudio.
    E.2.2Secondary objectives of the trial
    Reference is made to section 2.1 (p.35-36) of the Clinical Trial Protocol.
    Se hace referencia a la sección 2.1 (p. 39) del Protocolo de ensayo clínico.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A substudy of VX-950HPC3008 to evaluate the intensive steady-state pharmacokinetic profile of telaprevir and selected antiretrovirals
    Subestudio de VX-950HPC3008 para evaluar el perfil farmacocinético intensivo en estado de equilibrio del telaprevir y de determinados antirretrovirales.
    E.3Principal inclusion criteria
    - HCV RNA more than 6 months prior screening or histological diagnosis based on liver biopsy or fibroscan) HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL.
    - Confirmed diagnosis of HIV-1 infection >6 months before the screening visit.
    - CD4 count >300 cells/mm3 at screening and no value <200 cells/mm3 within 6 months of screening visit.
    - HIV-1 RNA undetectable by an ultrasensitive assay at least once within 90 days of the screening visit.
    - No HIV RNA values >200 copies/mL within 6 months of the screening visit.
    - HIV-1 RNA <50 copies/mL by Roche Taqman HIV-1 RNA v2 at screening.
    -ARN del VHC de más de 6 meses antes de la selección o diagnóstico histológico basado en biopsia hepática o fibroscan. Infección por VHC genotipo 1 con ARN del VHC > 1,000 IU/mL.
    -Diagnóstico confirmado de infección por VIH-1 más de 6 meses antes de la visita de selección
    -Recuento de CD4> 300 células/mm3 en la selección y no tener ningún valor <200 cells/mm3 en los 6 meses anteriores a la selección.
    -ARN del VIH-1 indetectables mediante un análisis ultrasensible al menos una vez en los 90 días previos a la visita de selección
    -No valores de ARN del VIH > 200 copias/ml en los 6 meses previos a la visita de selección.
    - ARN VIH-1 <50 copias / mL por Roche TaqMan ARN VIH-1 v2 en l a selección
    E.4Principal exclusion criteria
    - Anticipated need to switch HAART regimens from screening through the Telaprevir treatment period
    - Infection or co-infection with HCV other than genotype 1
    - Contraindication to the administration of Peg-IFN-alfa or RBV
    - Hepatitis B virus (HBV) co-infection
    - Acute or active condition of HIV-associated opportunistic infection within 6 months of screening
    - Pre-existing psychiatric condition
    - Evidence of hepatic decompensation.
    -Necesidad prevista de cambiar los regímenes de TARGA desde la selección y durante todo el periodo de tratamiento con Telaprevir.
    -La infección o coinfección con VHC de genotipo distinto a genotipo 1.
    -Contraindicacion a la administración del Peg-IFN-alfa o RBV
    -Coinfección con Hepatitis B (VHB).
    -Infección oportunista relacionada con el VIH aguda o activa en los 6 meses previos a la selección
    -condición psiquiátrica pre-existente.
    - La evidencia de descompensación hepática.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
    Proporción de pacientes que alcanzaron los niveles indectables en plasma de ácido ribonucleico (ARN) del VHC
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after the last planned dose of study drug
    12 semanas después de la última dosis del fármaco prevista del estudio
    E.5.2Secondary end point(s)
    - Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
    - Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
    - Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
    - Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
    - Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
    - Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels
    - Proportion of patients having confirmed detectable HCV ribonucleic acid (RNA levels)
    - Proportion of patients having an increase > 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA > 100 IU/mL in subjects whose HCV RNA has previously become < 25 IU/mL during treatment
    - Evaluate safety and tolerability of telaprevir in combination with Peg-IFN-alfa-2a and RBV and permitted HIV ARVs as assessed by AEs
    - Proporción de pacientes que alcanzaron los niveles indetectables en plasma de ácido ribonucleico (ARN) de VHC
    - Proporción de pacientes que alcanzaron los niveles indetectables en plasma de ácido ribonucleico (ARN) de VHC
    - Proporción de pacientes que alcanzaron los niveles indetectables en plasma de ácido ribonucleico (ARN) de VHC
    - Proporción de pacientes que alcanzaron los niveles indetectables en plasma de ácido ribonucleico (ARN) de VHC
    - Proporción de pacientes que alcanzaron los niveles indetectables en plasma de ácido ribonucleico (ARN) de VHC
    -Proporción de pacientes que han confirmado ácido ribonucleico del VHC (niveles de ARN) detectable.
    -Proporción de pacientes que han tenido un aumento > 1 log en el nivel de ARN del VHC desde el nivel más bajo alcanzado, o un valor de ARN del VHC> 100 UI /ml en pacientes cuyo valor de ARN del VHC había alcanzado previamente < 25 IU/mL durante el tratamiento.

    -Evaluar la seguridad y la tolerabilidad de telaprevir en combinación con Peg-IFN-alfa-2a and RBV y los ARV de VIH permitidos mediante la valoración de los EAs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 24 weeks after last planned dose of study drug
    - week 4 of study drug
    - week 12 of study drug
    - week 4 and week 12 of study drug
    - actual end of study drug (week 24, week 48 or early discontinuation)
    - planned end of study drug (week 24 or week 48)
    - follow-up period after previous undetectable HCV RNA levels at actual end of study drugs (week 24 or 48 or early discontinuation)
    - from day 1 till week 24 or 48
    - from time signed and dated ICF until follow-up visit 4 weeks after intake last medication
    - 24 semanas después de la última dosis del fármaco del estudio previsto
    - 4 semanas del fármaco en estudio
    - 12 semanas del fármaco en estudio
    - 4 semanas y 12 semanas del fármaco en estudio
    - Final real del fármaco del estudio (semana 24, la semana 48 o la interrupción temprana)
    - Finalización prevista del fármaco del estudio (semana 24 o 48 semanas)
    - El período de seguimiento después de anteriores niveles indetectables de ARN del VHC en el final real de los fármacos del estudio (semana 24 o 48 o la interrupción temprana)
    - Desde el día 1 hasta la semana 24 o 48
    - desde el momento en que se ha firmado y fechado el consentimiento informado hasta la visita de seguimiento 4 semanas después de la útima toma de medicación.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 No
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    France
    Poland
    Russian Federation
    Spain
    Sweden
    United Kingdom
    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
    LSLV
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 146
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 89
    F.4.2.2In the whole clinical trial 150
    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)
    not different from normal treatment of the condition
    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 Decision2012-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
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