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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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:2014-001249-26
    Sponsor's Protocol Code Number:GS-US-337-1431
    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:2015-06-15
    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 number2014-001249-26
    A.3Full title of the trial
    A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic Hepatitis C Infection in Gilead-Sponsored Trials
    Registro para sujetos con cirrosis que consiguen una respuesta virológica sostenida después del tratamiento con un régimen basado en sofosbuvir sin interferón para la infección por hepatitis C crónica en ensayos promovidos por Gilead
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term study to follow cirrhotic patients infected with chronic Hepatitis C who achieved a cure following treatment in a Gilead clinical trial.
    Estudio a largo plazo para el seguimiento de pacientes cirróticos infectados con hepatitis C crónica que se hayan curado tras el tratamiento en un ensayo clínico de Gilead.
    A.4.1Sponsor's protocol code numberGS-US-337-1431
    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 SponsorGilead Sciences, Inc.
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+34911142244
    B.5.6E-mailclinical.trials@gilead.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 Sovaldi
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd.
    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 namesofosbuvir
    D.3.2Product code GS-7977
    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.3.8INN - Proposed INNSofosbuvir
    D.3.9.1CAS number 1190307-88-0
    D.3.9.2Current sponsor codeGS-7977
    D.3.9.3Other descriptive nameSOFOSBUVIR
    D.3.9.4EV Substance CodeSUB121170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Harvoni
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd.
    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 nameLedipasvir/Sofosbuvir
    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.3.8INN - Proposed INNLedipasvir
    D.3.9.2Current sponsor codeGS-5885
    D.3.9.3Other descriptive nameGS-5885
    D.3.9.4EV Substance CodeSUB32080
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSofosbuvir
    D.3.9.1CAS number 1190307-88-0
    D.3.9.2Current sponsor codeGS-7977
    D.3.9.3Other descriptive nameSOFOSBUVIR
    D.3.9.4EV Substance CodeSUB121170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 Virus Infection
    Infección por el virus de la hepatitis C
    E.1.1.1Medical condition in easily understood language
    Hepatitis C
    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 18.0
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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 durability of SVR; To assess clinical progression or regression of liver disease, including the incidence of hepatocellular carcinoma (HCC) following SVR.
    Evaluar la durabilidad de la RVS; evaluar la progresión o regresión clínicas de la enfermedad hepática, incluida la incidencia de carcinoma hepatocelular (CHC) después de la RVS.
    E.2.2Secondary objectives of the trial
    To determine whether subsequent detection of HCV RNA in subjects who relapse following SVR represents the re-emergence of pre-existing virus, the development of resistance mutations, or re-infection.

    To assess quality of life following SVR.
    Determinar si la posterior detección de ARN del VHC en sujetos que presenten recidiva después de la RVS supone la reaparición del virus preexistente, el desarrollo de mutaciones de resistencia o una nueva infección.

    Evaluar la calidad de vida después de la RVS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Willing and able to provide written informed consent;
    2) Have previously participated in a Gilead-sponsored HCV study and received a sofosbuvir-containing regimen without interferon;
    3) Have achieved SVR in a Gilead-sponsored study, as defined in the treatment protocol;
    4) Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver transplant after receiving a SOF-containing regimen.
    1) Ser capaces de y estar dispuestos a otorgar su consentimiento informado por escrito;
    2) Haber participado previamente en un estudio de VHC promovido por Gilead y haber recibido un régimen que contuviera sofosbuvir sin interferón;
    3) Haber conseguido en un estudio promovido por Gilead una RVS, según la definición del protocolo de tratamiento;
    4) Tener cirrosis hepática, según la definición del protocolo de tratamiento, y no haberse sometido a un trasplante de hígado después de recibir el régimen con SOF.
    E.4Principal exclusion criteria
    1) Subject plans to initiate a new course of HCV therapy, including approved products and any
    investigational agents, during the course of this Registry;
    2) History of clinically-significant illness or any other major medical disorder that may interfere
    with the subject follow-up, assessments or compliance with the protocol.
    1) El sujeto tiene previsto iniciar, durante el transcurso de este registro, un nuevo curso de tratamiento para el VHC, lo que incluye productos aprobados y cualquier agente en fase de investigación;
    2) Tener antecedentes de una enfermedad clínicamente significativa o de cualquier otro trastorno médico importante que pudieran interferir con el seguimiento del sujeto, las evaluaciones o el cumplimiento del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the durability of SVR;

    To assess clinical progression or regression of liver disease, including the incidence of hepatocellular carcinoma (HCC) following SVR.
    Evaluar la durabilidad de la RVS;

    Evaluar la progresión o regresión clínicas de la enfermedad hepática, incluida la incidencia de carcinoma hepatocelular (CHC) después de la RVS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The proportion of subjects maintaining SVR at Week 240;

    The proportion of subjects who develop liver disease progression or regression, as assessed by clinical and laboratory parameters throughout the study;

    The proportion of subjects who develop HCC through Week 240.
    La proporción de sujetos que mantengan una RVS hasta la semana 240;

    La proporción de sujetos que presenten una evolución de la enfermedad hepática o regresión, evaluada por parametros clínicos y de laboratorio durante todo el estudio;

    La proporción de sujetos que desarrollen CHC hasta la semana 240.
    E.5.2Secondary end point(s)
    To determine whether subsequent detection of HCV RNA in subjects who relapse following SVR represents the re-emergence of pre-existing virus, the development of resistance mutations, or re-infection.
    Determinar si la posterior detección de ARN del VHC en sujetos que presenten recidiva después de la RVS supone la reaparición del virus preexistente, el desarrollo de mutaciones de resistencia o una nueva infección.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The proportion of subjects with detectable HCV RNA due to re-emergence of pre-existing virus through Week 240;

    The proportion of subjects with detectable HCV resistance mutations through Week 240.

    The proportion of subjects with detectable HCV RNA due to re-infection through Week 240.
    La proporción de sujetos con ARN del VHC detectable a causa de la reaparición del virus preexistente hasta la semana 240;

    La proporción de sujetos con mutaciones de resistencia del VHC detectables hasta la semana 240;

    La proporción de sujetos con ARN del VHC detectable a causa de una nueva infección hasta la semana 240.
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Observational study
    Estudio observacional
    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 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 EEA75
    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
    Canada
    France
    Germany
    Italy
    New Zealand
    Spain
    United Kingdom
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    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 years7
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2015-06-15. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 2000
    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)
    This study is an observational study, following patients who have participated in Gilead-sponsored HCV studies. Patients will be followed for five years.
    Este es un estudio observacional para el seguimiento de pacientes que hayan participado en ensayos de Hepatitis C patrocinados por Gilead. Se realizará un seguimiento de los sujetos durante 5 años una vez inscritos.
    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 Decision2015-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
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