Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35236   clinical trials with a EudraCT protocol, of which   5759   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-003088-23
    Sponsor's Protocol Code Number:M13-099
    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:2012-11-26
    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 number2012-003088-23
    A.3Full title of the trial
    A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adults with Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
    Estudio aleatorizado y abierto para evaluar la seguridad y la eficacia de ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) y ABT-333 administrados junto con ribavirina (RBV) en adultos con infección
    crónica por el virus de la hepatitis C (VHC) del genotipo 1 y con cirrosis (TURQUOISE-II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, open-label study to evaluate the safety and Effect of three experimental drugs ABT-450, ABT-267 and ABT-333 Coadministered with Ribavirin (RBV) in people with Genotype 1 hepatitis C Virus (HCV) and early liver damage. "Experimental" means that they have not been approved by any regulatory agency for sale to the public.
    Estudio abierto, aleatorizado para evaluar la seguridad y el efecto de tres fármacos experimentales: ABT-450, ABT-267 y ABT-333 coadministrados con Ribavirina (RBV) en personas con virus de la hepatitis C (HCV) Genotipo 1 y daño hepático temprano. "Experimental" significa que no han sido aprobados por ninguna agencia regulatoria para la venta al público.
    A.4.1Sponsor's protocol code numberM13-099
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointeuclinicaltrials@abbott.com
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628644475
    B.5.5Fax number+441628644330
    B.5.6E-maileuclinicaltrials@abbott.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 No
    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 nameABT-450/r/ABT-267
    D.3.2Product code ABT-450/r/ABT-267
    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 INNABT-450
    D.3.9.2Current sponsor codeABT-450
    D.3.9.3Other descriptive nameABT-450
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRITONAVIR
    D.3.9.1CAS number 155213-67-5
    D.3.9.4EV Substance CodeSUB10342MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABT-267
    D.3.9.2Current sponsor codeABT-267
    D.3.9.3Other descriptive nameABT-267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 No
    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 nameABT-333
    D.3.2Product code ABT-333
    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 INNABT-333
    D.3.9.2Current sponsor codeABT-333
    D.3.9.3Other descriptive nameABT-333
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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: 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.2.5The 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 nameRibavirin
    D.3.2Product code Ribavirin
    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.3.9.3Other descriptive nameRIBAVIRIN
    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 Infection and compensated cirrhosis
    Infección Crónica por Hepatitis C y cirrosis compensada.
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C Infection and early liver damage.
    Infección Crónica por Hepatitis C y daño hepático precoz.
    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 PT
    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
    The primary objectives of this study are to assess efficacy (the percentage of subjects achieving a 12-week sustained virologic response, SVR12 (HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment) and safety of coformulated ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333 coadministered with RBV for 12 or 24 weeks in HCV genotype 1-infected adults with compensated cirrhosis.
    Los objetivos principales de este estudio son evaluar la eficacia (el porcentaje de pacientes que alcanzan una respuesta virológica sostenida a las 12 semanas, RVS12 (ácido ribonucleico (ARN) del VHC < límite inferior de cuantificación (LIC) 12 semanas después del tratamiento), y la seguridad de ABT-450, ritonavir y ABT-267 coformulados (ABT-450r/ABT-267) y ABT-333 administrados junto con RBV durante 12 o 24 semanas en adultos con infección por el VHC del genotipo 1 y cirrosis compensada
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to assess the rapid virologic response rate (RVR) (the percentage of subjects with HCV RNA < LLOQ at Week 4), the end of treatment response (EOTR) rate (the percentage of subjects with HCV RNA < LLOQ at Week 12 for the 12-week arm or at Week 24 for the 24-week arm) and compare SVR12 between the two arms.
    Los objetivos secundarios de este estudio son evaluar la tasa de respuestas virológicas rápidas (RVR) (el porcentaje de pacientes con ARN del VHC < LIC en la semana 4) y la tasa de respuestas al final del tratamiento (RFDT) (el porcentaje de pacientes con ARN del VHC < LIC en la semana 12 en el grupo de la semana 12 o la semana 24 en el grupo de la semana 24) y comparar la RVS12 entre los dos grupos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Males or females 18 - 70 years old, inclusive
    -Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
    -Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening
    -Subject has either never received antiviral treatment for hepatitis C infection or has received prior pegIFN/RBV treatment and did not respond
    -Documentation of cirrhosis (Child Pugh A)
    -Hombres o mujeres entre 18 -70 años (ambos incluidos)
    -Las mujeres deben ser postmenopausicas de mas de dos años, esterilizadas quirurgicamente o que utilicen métodos anticonceptivos específicos.
    -Hepatisis C crónica, infección genotipo 1 (Niveles HCV RNA mayores o iguales a 10.000 IU/ml en Screening)
    -Paciente que no haya recibido nunca un tratamiento antiviral para la infección por hepatitis C o haya recibido tratamiento previo con pegIFN/RBV pero no respondiera al tratamiento.
    -Documentación de cirrosis (Child Pugh A)
    E.4Principal exclusion criteria
    -Positive screen for drugs or alcohol
    -Significant sensitivity to any drug
    -Use of contraindicated medications within 2 weeks of dosing
    -Abnormal laboratory tests
    -Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus antibody
    -Resultado positivo al análisis de drogas o alcohol.
    -Sensibilidad significativa a cualquier fármaco.
    -Uso de fármacos contraindicados dentro de las dos semanas anteriores a iniciar tratamiento.
    -Pruebas de laboratorio anormales
    -Antigeno de superficie positivo de Hepatitis B y anticuerpos anti-virus de la inmunodeficiencia humana.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the percentage of subjects with SVR12.
    El criterio de valoración principal es el porcentaje de pacientes con RVS12
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after last dose of study drug
    12 semanas después de la última dosis real de la medicación del estudio
    E.5.2Secondary end point(s)
    The secondary endpoints are:
    1. The percentage of subjects with rapid virologic response (HCV RNA < LLOQ at Week 4);
    2. The percentage of subjects with end of treatment response (HCV RNA < LLOQ at the end of treatment)
    3. The comparison of the percentage of subjects with SVR12 between
    the two arms.
    Los objetivos secundarios son:
    1. El porcentaje de sujetos con rápida respuesta virológica (HCV RNA < LLOQ en semana 4)
    2. El porcentaje de sujetos con respuesta al fin del tratamiento (HCV RNA < LLOQ al final del tratamiento)
    3. La comparación del porcentaje de sujetos con SVR12 en los dos brazos de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 4 weeks after the first dose of study drug;
    2. 12 or 24 weeks after the first dose of study drug.
    3. 12 weeks after the last dose of study drug for the 12 week
    arm and 24 weeks after the last dose of study drug for the 24 week arm.
    E.5.2.1 Momento de evaluación de este objetivo:
    1. 4 semanas después de la primera dosis del fármaco del estudio.
    2. 12 ó 24 semanas después de la primera dosis del fármaco del estudio.
    3. 12 semanas después de la última dosis del fármaco del estudio para el brazo de 12 semanas y 24 semanas después de la última dosis del fármaco del estudio para el brazo de 24 semanas.
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Puerto Rico
    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 Subject Last Visit
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 148
    F.4.2.2In the whole clinical trial 300
    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)
    All subjects may participate in an Abbott observational study to evaluate the durability of virologic response for subjects who achieve SVR and subjects who fail treatment. All subjects who do not achieve and maintain virologic suppression (HCV RNA < LLOQ), or who relapse post DAA therapy, may enter another Abbott study including ABT-450/r + ABT 267 + pegIFN/RBV. Subjects may be offered another non-Abbott treatment as determined appropriate by the investigator.
    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 Decision2013-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-24
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA