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    Summary
    EudraCT Number:2011-005762-38
    Sponsor's Protocol Code Number:M13-393
    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:2012-05-28
    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 number2011-005762-38
    A.3Full title of the trial
    A Randomized, Open-Label Study to Evaluate the
    Safety and Efficacy of Coadministration of ABT-450
    with Ritonavir (ABT-450/r) and ABT-267 in Adults
    with Chronic Hepatitis C Virus Infection (PEARL-I)
    Estudio abierto y aleatorizado para evaluar la seguridad y la eficacia de la administración simultánea de ABT 450 con ritonavir (ABT 450/r) y ABT 267 en adultos con infección crónica por el virus de la hepatitis C (PEARL I)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 with Ritonavir (ABT-450/r) and ABT-267 in Adults with Chronic Hepatitis C Virus Infection
    Un estudio para evaluar la seguridad y eficacia de la administración simultanea de ABT-450 con ritonavir (ABT-450/r) y ABT-267 en adultos con infección crónica por virus de la Hepatitis C
    A.4.1Sponsor's protocol code numberM13-393
    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 SponsorAbbott 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 supportAbbott Laboratories
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Laboratories
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44162877 4695
    B.5.5Fax number+44162864 4330
    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
    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.3.9.2Current sponsor codeABT-450
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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-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.3.9.2Current sponsor codeABT-267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.2.1.1.1Trade name Norvir 100 mg soft capsules
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited
    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.3.4Pharmaceutical form Capsule, soft
    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 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 number100
    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
    Infección por Hepatitis C Crónica
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis C Infection
    Infección por Hepatitis C Crónica
    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 10008909
    E.1.2Term Chronic hepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    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 of this study is to assess the safety and efficacy (the percentage of subjects with HCV RNA < LLOQ 12 weeks after the last dose of study drug [SVR12]) comparing Groups 1 and 2 and Groups 4 and 5.
    El objetivo principal de este estudio es evaluar la seguridad y la eficacia (el porcentaje de sujetos con valores de ARN del VHC < LIC 12 semanas después de la última dosis real de la medicación del estudio [RVS12 real] después de 8 o 12 semanas de tratamiento) comparando los grupos 1 y 2 y los grupos 4 y 5
    E.2.2Secondary objectives of the trial
    - To assess the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last dose of study drug), comparing Groups 2 and 3,
    - To assess the percentage of subjects with SVR24 (HCV RNA < LLOQ 24 weeks after the last dose of study drug), comparing Groups 1 and 2, Groups 4 and 5, and Groups 2 and 3,
    - To assess the percentage of subjects with end of treatment response (HCV RNA < LLOQ at the end of treatment), comparing Groups 1 and 2, Groups 4 and 5, and Groups 2 and 3
    - Evaluar el porcentaje de sujetos con RVS12 real (ARN del VHC < LIC 12 semanas después de la última dosis real de la medicación del estudio), comparando los grupos 2 y 3.
    - Evaluar el porcentaje de sujetos con RVS24 real (ARN del VHC < LIC 24 semanas después de la última dosis real de la medicación del estudio), comparando los grupos 1 y 2, los grupos 4 y 5 y los grupos 2 y 3.
    - Evaluar el porcentaje de sujetos con RFT (ARN del VHC < LIC al final del tratamiento), comparando los grupos 1 y 2, los grupos 4 y 5 y los grupos 2 y 3
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female between the age of 18 and 70 years, inclusive, at time of enrollment.
    2.Subjects must meet one of the following categories:
    ?Never received antiviral treatment for hepatitis C infection;
    ?Documented null-response (received at least 10 weeks of pegIFN/RBV for the treatment of HCV and failure to achieve a 2 log10 IU/ml reduction in HCV RNA at week 12 (Week 10-16).
    3.Body mass index (BMI) is ? 18 to < 38 kg/m2. BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
    4.Chronic HCV genotype 1-infection for at least 6 months prior to study enrollment.
    5.Subject has plasma HCV RNA level > 10,000 IU/mL at Screening.
    1.Varones o mujeres de 18 a 70 años, inclusive, en el momento de la inclusión.
    2.Los sujetos deben cumplir uno de los siguientes criterios de categoría:
    - No haber recibido nunca tratamiento antiviral para la infección por el virus de la hepatitis C.
    - Respuesta nula documentada (después de recibir al menos 10 semanas de pegIFN/RBV para el tratamiento del VHC sin alcanzar una reducción del ARN del VHC de 2 log10 UI/ml en la semana 12 (semana 10-16).
    3. Índice de masa corporal (IMC) entre ? 18 y < 38 kg/m2. El IMC se calcula como el peso en kilogramos (kg) dividido entre el cuadrado de la talla medida en metros (m).
    4. Infección crónica por el VHC de genotipo 1 durante al menos 6 meses antes de la inclusión en el estudio.
    5. El sujeto tiene una concentración plasmática de ARN del VHC > 10.000 UI/ml en la visita de selección.
    E.4Principal exclusion criteria
    1.History of severe, life-threatening or other significant sensitivity to any drug.
    2.Females who are pregnant or breastfeeding.
    3.Recent history of drug or alcohol abuse that could preclude adherence to the protocol.
    4.Positive test result for hepatitis B surface antigen or anti-HIV antibodies.
    5.Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis.
    1 Antecedentes de hipersensibilidad grave, potencialmente mortal o significativa a cualquiera de los medicamentos.
    2. Mujeres embarazadas o lactantes.
    3. Antecedentes recientes de alcoholismo o toxicomanía que podrían impedir el cumplimiento del protocolo.
    4. Resultado positivo en el análisis del antígeno de superficie del virus de la hepatitis B o de anticuerpos contra el VIH.
    5. Signos clínicos actuales o antiguos de cirrosis, como ascitis o varices esofágicas, o biopsia previa que muestre cirrosis
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to assess the safety and efficacy (the percentage of subjects with HCV RNA < LLOQ 12 weeks after the last dose of study drug [SVR12]) comparing Groups 1 and 2 and Groups 4 and 5.
    El objetivo principal de este estudio es evaluar la seguridad y la eficacia (el porcentaje de sujetos con valores de ARN del VHC < LIC 12 semanas después de la última dosis real de la medicación del estudio [RVS12 real] después de 8 o 12 semanas de tratamiento) comparando los grupos 1 y 2 y los grupos 4 y 5
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after last dose of study drug
    12 semanas después de la úlima dosis de medicación del estudio
    E.5.2Secondary end point(s)
    - To assess the percentage of subjects with SVR12 (HCV RNA < LLOQ 12 weeks after the last dose of study drug), comparing Groups 2 and 3,
    - To assess the percentage of subjects with SVR24 (HCV RNA < LLOQ 24 weeks after the last dose of study drug), comparing Groups 1 and 2, Groups 4 and 5, and Groups 2 and 3,
    - To assess the percentage of subjects with end of treatment response (HCV RNA < LLOQ at the end of treatment), comparing Groups 1 and 2, Groups 4 and 5, and Groups 2 and 3
    - Evaluar el porcentaje de sujetos con RVS12 real (ARN del VHC < LIC 12 semanas después de la última dosis real de la medicación del estudio), comparando los grupos 2 y 3.
    - Evaluar el porcentaje de sujetos con RVS24 real (ARN del VHC < LIC 24 semanas después de la última dosis real de la medicación del estudio), comparando los grupos 1 y 2, los grupos 4 y 5 y los grupos 2 y 3.
    - Evaluar el porcentaje de sujetos con RFT (ARN del VHC < LIC al final del tratamiento), comparando los grupos 1 y 2, los grupos 4 y 5 y los grupos 2 y 3
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks after last dose of study drug, 4 weeks after first dose of study drug, End of treatment
    24 semanas después de la última dosis de medicación del estudio, 4 semanas después de la primera dosis de medicación del estudio. Fin del tratamiento.
    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 Yes
    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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    not applicable
    E.8.2.4Number of treatment arms in the trial5
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    France
    Hungary
    Italy
    Poland
    Puerto Rico
    Romania
    Spain
    Turkey
    United States
    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
    Last subject last visit
    Ultima visita del ultimo paciente
    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 months20
    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 months22
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 200
    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 who receive at least one dose of DAA and who do not achieve and maintain virologic suppression (HCV RNA < LLOQ), or who relapse post DAA therapy, may be offered participation in a separate, Abbott-sponsored treatment study, or may be offered another off-study (non-Abbott) treatment regimen, 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 Decision2012-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-17
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