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    Summary
    EudraCT Number:2011-002668-25
    Sponsor's Protocol Code Number:VX11-950-115
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-12-12
    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 number2011-002668-25
    A.3Full title of the trial
    An Open-Label, Phase 3 Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Coinfected With Genotype 1 Hepatitis C Virus and Human Immunodeficiency Virus Type 1(HCV/HIV-1)
    Estudio abierto, de fase III, de telaprevir en asociación con peginterferón alfa 2a (Pegasys®) y ribavirina (Copegus®), en sujetos
    coinfectados por el virus de la hepatitis C de genotipo 1 y por el virus de la inmunodeficiencia humana de tipo 1 (VHC/VIH-1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety and effectiveness of telaprevir in combination with peginterferon alfa-2a and ribavirin in treating chronic hepatitis C virus infection in subjects who are co-infected with hepatitis C virus and immunodeficiency virus (HIV).
    Estudio para investigar la seguridad y efectividad de telaprevir en
    combinación con peginterferón alfa-2a y ribavirina en el tratamiento de
    la hepatitis C crónica por infección virica en sujetos coinfectados con el
    virus de la hepatitis C y por el virus de la inmunodeficiencia (VIH)
    A.4.1Sponsor's protocol code numberVX11-950-115
    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 SponsorVertex Pharmaceuticals Incorporated
    B.1.3.4CountryUnited States
    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 supportVertex Pharmaceuticals Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVertex Pharmaceuticals Incorporated
    B.5.2Functional name of contact pointMedical Information Center
    B.5.3 Address:
    B.5.3.1Street Address130 Waverly Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number16176348789
    B.5.5Fax numbernot applicable
    B.5.6E-mailmedicalinfo@vrtx.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 INCIVEK
    D.2.1.1.2Name of the Marketing Authorisation holderVertex Pharmaceuticals Incorporated
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nametelaprevir
    D.3.2Product code VX-950
    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 INNtelaprevir
    D.3.9.1CAS number 402957-28-2
    D.3.9.2Current sponsor codeVX-950
    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.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 Pegasys
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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.3.1Product namePegasys
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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.3.9.4EV 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 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) 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 Yes
    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 Copegus
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameCopegus
    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.3.9.4EV 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
    chronic hepatitis C virus infection
    Infección cronica por el virus de la Hepatitis C
    E.1.1.1Medical condition in easily understood language
    chronic hepatitis C virus infection
    Infección cronica por el virus de la 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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the hepatitis C antiviral efficacy of telaprevir, peginterferon alfa-2a, and ribavirin
    Evaluar la eficacia antivírica en la Hepatitis C de telaprevir, peginterferon alfa-2a y reibavirina
    E.2.2Secondary objectives of the trial
    - To assess safety and tolerability of telaprevir, peginterferon alfa-2a, and ribavirin
    - To evaluate the pharmacokinetics of telaprevir, peginterferon alfa-2a, and ribavirin, and select highly active antiretroviral therapies
    - To monitor amino acid sequence changes in the HCV NS3.4A protease region
    - Evaluar la seguridad y tolerabilidad de telaprevir, peginterferón alfa-2a y ribavirina.
    - Evaluar la famacocinética de telaprevir, peginterferón alfa-2a, ribavirina y fármacos del TARGA seleccionado.
    - Controlar los cambios en la secuencia de aminoácidos en la región de la proteasa NS3.4A del VHC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects must have chronic, genotype 1a or 1b, hepatitis C at Screening
    - Subjects must have a diagnosis of HIV-1 infection >6 months before Screening
    - Taking 1 of the following permissible HAART regimens for HIV continuously >/=12 weeks before Day 1 without switches
    - Male and female subjects 18 to 65 years of age, inclusive
    - Female subjects must not be pregnant or planning to become pregnant within 72 weeks after enrolling in the study, or they must be permanently sterile or otherwise of nonchildbearing potential. Female subjects must also not be breastfeeding.
    - Los pacientes deberán padecer hepatitis C crónica tipo 1a o 1b en la fase de selección.
    - El paciente deberá disponer de un diagnóstico de infección por VIH-1 > 6 meses antes de la fase de detección.
    - Administración de una de las pautas terapéuticas del TARGA permitidas para el VIH de forma continua >/=12 semanas antes del día 1, sin cambios.
    - Hombres y mujeres de entre 18 y 65 años, ambos incluidos.
    - Las mujeres no podrán estar embarazadas ni tener pensado quedarse embarazadas en las 72 semanas posteriores a su inclusión en el estudio o deberán ser estériles de forma permanente o no estar en edad fértil. Las mujeres tampoco podrán estar en período de lactancia.
    E.4Principal exclusion criteria
    - Use of azidothymidine (AZT), didanosine (ddI) or stavudine (d4T) nucleosides
    - Evidence of hepatic decompensation
    - Clinical suspicion of acute hepatitis
    - Any other cause of liver disease in addition to hepatitis C
    - Diagnosed or suspected hepatocellular carcinoma
    - Pre-existing psychiatric condition
    - Medical condition that requires frequent or prolonged use of systemic corticosteroids
    - Previous treatment with an HCV protease inhibitor
    - Uso de nucleósidos de azidotimidina (AZT), didanosina (ddI) o estavudina (d4T).
    - Signos de descompensación hepática
    - Sospecha clínica de hepatitis aguda.
    - Cualquier otra causa de enfermedad hepática además de la hepatitis C.
    - Carcinoma hepatocelular diagnosticado o sospechado.
    - Enfermedad psiquiátrica preexistente.
    - Enfermedad que requiera un uso frecuente o prolongado de corticoesteroides sistémicos.
    - Tratamiento previo con un inhibidor de la proteasa del VHC.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who achieve undetectable HCV RNA 12 weeks after the last planned dose of study drug
    Proporción de sujetos que alcanzan un nivel indetectable de ARN del VHC tras 12 semanas desde la última dosis planificada del fármaco de estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study Week 60
    Semana 60 del estudio.
    E.5.2Secondary end point(s)
    - Proportion of subjects who achieve undetectable HCV RNA 24 weeks after the last planned dose of study drug (SVR24)
    - Proportion of subjects who achieve undetectable HCV RNA at Week 4 (RVR), Week 4 and 12 (eRVR), and planned End of Treatment (EOT)
    - Safety as assessed by AEs, clinical laboratory results, HIV RNA assessments, CD4 counts, 12-lead electrocardiogram (ECGs), and vital signs
    - PK of telaprevir, Peg-IFN, RBV, and selected HAART medications
    - Amino acid sequence of the HCV NS3.4A protease region
    - Proporción de sujetos que alcanzan un nivel indetectable de ARN del VHC tras 24 semanas desde la última dosis planificada del fármaco de estudio (SVR24).
    - Proporción de sujetos que alcanzan un nivel indetectable de ARN del VHC en la semana 4 (RVR), en la semana 4 y 12 (eRVR) y al finalizar el tratamiento planificado (FDT).
    - Seguridad evaluada de acuerdo con los AA, los resultados analíticos, las evaluaciones del ARN del VIH, los recuentos de linfocitos CD4, los electrocardiogramas (ECG) de 12 derivaciones y las constantes vitales.
    - FC de telaprevir, Peg-IFN, ribavirina y fármacos del TARGA seleccionado.
    - Secuencia de aminoácidos de la región de la proteasa NS3.4A del VHC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Study Week 72
    Semana 72 del estudio.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) 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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Canada
    Mexico
    United States
    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
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 160
    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 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 160
    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)
    Subjects will not be offered continued treatment or medical management after the end of the trial. Vertex will inform subjects of this in writing. Any subject who does not give their written consent to this condition will not be allowed to participate in the study.
    No se les ofrecerá a los pacientes continuación del tratamiento o dirección medica después de la finalización del estudio. Vertex informará de esto a los pacientes por escrito. Cualquier paciente que no de su consentimiento por escrito a esta condición no se le permitirá participar en el estudio.
    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 Decision2012-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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