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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2012-002473-61
    Sponsor's Protocol Code Number:GS-US-321-0102
    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:2013-04-09
    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 number2012-002473-61
    A.3Full title of the trial
    A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects with Primary Sclerosing Cholangitis (PSC)
    Ensayo en fase 2b, de determinación de dosis, aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de GS 6624, un anticuerpo monoclonal contra la proteína tipo lisil oxidasa 2 (LOXL2 ), en pacientes con colangitis esclerosante primaria (CEP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An investigational study to assess the safety and efficacy of a new investigational drug in subjects with primary sclerosing cholangitis (PSC)
    Estudio de investigación para evaluar la seguridad y la eficacia de un nuevo fármaco en investigación en pacientes con colangitis esclerosante primaria (CEP)
    A.4.1Sponsor's protocol code numberGS-US-321-0102
    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 Inc
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address333 Lakeside Drive
    B.5.3.2Town/ cityFoster City
    B.5.3.3Post codeCA 94404
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1650574 3000
    B.5.5Fax number+1650578 9264
    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 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.3.2Product code GS-6624
    D.3.4Pharmaceutical form Solution for injection
    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 INNGS-6624
    D.3.9.2Current sponsor codeGS-6624
    D.3.9.4EV Substance CodeSUB33243
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 INNGS-6624
    D.3.9.2Current sponsor codeGS-6624
    D.3.9.4EV Substance CodeSUB33243
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Sclerosing Cholangitis (PSC)
    Colangitis esclerosante primaria (CEP)
    E.1.1.1Medical condition in easily understood language
    Primary Sclerosing Cholangitis (PSC)
    Colangitis esclerosante primaria (CEP)
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036732
    E.1.2Term Primary sclerosing cholangitis
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether simtuzumab (formally referred to as GS-6624) is effective at preventing the progression of liver fibrosis in subjects with PSC.
    Evaluar si simtuzumab (denominado anteriormente GS 6624) es eficaz para prevenir la progresión de la fibrosis hepática en pacientes con CEP.
    E.2.2Secondary objectives of the trial
    - To assess the safety of simtuzumab in subjects with PSC;
    - To assess the pharmacokinetics of simtuzumab in subjects with PSC;
    - To assess the immunogenicity of simtuzumab in this population;
    - To assess whether baseline serum LOXL2 levels are predictive of response to simtuzumab therapy (active groups) and/or prognostic for disease progression (placebo group);
    - To compare different efficacy assessment tools in this population;
    - To determine whether non-invasive measures of fibrosis can predict regression of fibrosis and reversal of cirrhosis in this population.
    - Evaluar la seguridad de simtuzumab en pacientes con CEP.
    - Evaluar la farmacocinética de simtuzumab en pacientes con CEP.
    - Evaluar la inmunogenicidad de simtuzumab en esta población.
    - Evaluar si las concentraciones séricas basales de LOXL2 son predictivas de la respuesta al tratamiento con simtuzumab (grupos de tratamiento activo) y/o pronósticas de progresión de la enfermedad (grupo placebo).
    - Comparar distintos instrumentos de evaluación de la eficacia en esta población.
    - Determinar si medidas no invasivas de la fibrosis pueden predecir la regresión de la fibrosis y la corrección de la cirrosis en esta población.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    MRE Substudy
    The Magnetic Resonance Elastography (MRE) Substudy will consist of approximately 50 subjects from selected investigative sites with the ability to perform MRE. Subjects will undergo a liver stiffness assessment by MRE at Baseline Visit, Week 48 and the End of Treatment Visit (Week 96).

    Impedance Ultrasonography Substudy
    The Impedance Ultrasonography Substudy will consist of approximately 50 subjects from selected investigative sites with the ability to perform impedance ultrasonography (such as Fibroscan). Subjects will undergo a liver stiffness assessment by impedance ultrasonography at Baseline Visit, Week 48 and the End of Treatment Visit (Week 96).
    Subestudio de ERM
    En el subestudio de elastografía mediante resonancia magnética (ERM) participarán unos 50 pacientes procedentes de centros de investigación seleccionados con capacidad para realizar ERM. Estos pacientes se someterán a una evaluación de la rigidez hepática mediante ERM en la visita basal, en la semana 48 y en la visita de final del tratamiento (semana 96)

    Subestudio de ecografía de impedancia
    En el subestudio de ecografía de impedancia participarán unos 50 pacientes procedentes de centros de investigación seleccionados con capacidad para realizar dicha prueba (como Fibroscan). Estos pacientes se someterán a una evaluación de la rigidez hepática mediante ecografía de impedancia en la visita basal, en la semana 48 y en la visita de final del tratamiento (semana 96).
    E.3Principal inclusion criteria
    1. Males and females 18 - 65 years of age;
    2. Willing and able to provide informed, written consent;
    3. Chronic cholestatic liver disease of at least 6 months duration;
    4. Liver biopsy consistent with PSC;
    5. MRCP consistent with PSC;
    6. Exclusion of other causes of liver disease including viral hepatitis, alcoholic liver disease, primary biliary cirrhosis and secondary sclerosing cholangitis;
    7. Must be willing and able to comply with all study requirements;
    8. Must have AST and ALT ?10 x clULN;
    9. Must have serum creatinine < 2.0 mg/dL (176.8µmol/L);
    10. Female subjects of childbearing potential must have a negative serum pregnancy test prior to starting study treatment. For the purposes of this study, a female subject of childbearing
    potential is a woman who has not had a hysterectomy, bilateral oophorectomy, or medically-documented ovarian failure. Women ? 50 years of age with amenorrhea of any duration
    will be considered to be of childbearing potential;
    11. All sexually active female subjects who are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse from the Screening Visit throughout the study period and for 90 days following the last dose of study drug. If females utilize hormonal agents as one of their contraceptive methods, the same hormonal method must have been used for at least 1 month before study dosing. Females on hormonal methods must utilize a barrier method as the other form of contraception;
    12. Lactating females must agree to discontinue nursing before study investigational medicinal product administration;
    13. Male subjects, if not vasectomized, are required to use barrier contraception (condom plus spermicide) during heterosexual intercourse from screening through to study completion and
    for 90 days from the last dose of study investigational medicinal product.
    1. Varones y mujeres de 18-65 años de edad.
    2. Capacidad y disposición para otorgar el consentimiento informado por escrito.
    3. Hepatopatía colestásica crónica de al menos 6 meses de duración.
    4. Biopsia hepática compatible con CEP.
    5. CPRM compatible con CEP.
    6. Exclusión de otras causas de hepatopatía como hepatitis viral, hepatopatía alcohólica, cirrosis biliar primaria y colangitis esclerosante secundaria.
    7. Disposición y capacidad para cumplir todos los requisitos del estudio.
    8. AST y ALT ? 10 x LSNlc.
    9. Creatinina sérica < 2,0 mg/dl (176,8 µmol/l).
    10. Las mujeres en edad fértil deberán dar negativo en una prueba de embarazo en suero realizada antes del comienzo del tratamiento del estudio. A efectos de este estudio, una mujer en edad fértil es aquella que no se ha sometido a una histerectomía ni ovariectomía bilateral y que no tiene insuficiencia ovárica documentada médicamente. Se considerará en edad fértil a las mujeres de edad ? 50 años con amenorrea de cualquier duración.
    11. Todas las mujeres en edad fértil deberán comprometerse a utilizar un método anticonceptivo muy eficaz cuando mantengan relaciones heterosexuales desde la visita de selección, durante todo el período del estudio y hasta 90 días después de la última dosis del fármaco del estudio. En el caso de mujeres que utilicen fármacos hormonales como uno de los métodos anticonceptivos, deberá haberse utilizado el mismo método hormonal durante al menos un mes antes de la administración de la medicación del estudio. Las mujeres que estén empleando métodos hormonales deberán utilizar un método de barrera como el otro método anticonceptivo.
    12. Las mujeres lactantes deberán interrumpir la lactancia materna antes de la administración del medicamento en investigación del estudio.
    13. Los varones, en caso de no estar vasectomizados, deberán comprometerse a utilizar un método anticonceptivo de barrera (preservativo con espermicida) cuando mantengan relaciones heterosexuales desde la visita de selección, durante todo el período del estudio y hasta 90 días después de la última dosis del fármaco del estudio.
    E.4Principal exclusion criteria
    1. Pregnant or breast feeding;
    2. Any evidence of hepatic decompensation past or present, including ascites, episodes of hepatic encephalopathy, variceal bleeding or a prolonged PT/INR;
    3. HCV RNA positive;
    4. HBsAg positive;
    5. Positive anti-mitochondrial antibody;
    6. Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females;
    8. Current, active Ulcerative Colitis defined as either a partial Mayo score of > 2, a bleeding score of >0, or current use of any corticosteroid therapy, any immunomodulator and/or any inhibitor of tumor necrosis factor?? (TNF-?)
    Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at Screening. Subjects on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included in the study. Subjects with a positive urine drug screen due to
    prescription opiod-based medications are eligible if the prescription and diagnosis are reviewed and approved by the investigator.
    9. Clinically significant cardiac disease;
    10. History of cholangiocarcinoma. If a dominant stricture is found, cholangiocarcinoma must be ruled out by brush cytology or biopsy prior to randomization;
    11. History of cancer, other than non-melanomatous skin cancer, within 5 years prior to screening;
    12. Ascending cholangitis within 60 days of screening;
    13. Presence of a percutaneous drain or bile duct stent;
    14. Major surgical procedure within 30 days prior to screening or the presence of an open wound;
    15. Known hypersensitivity to the investigational product or any
    of its formulation excipients;
    16. History of bleeding diathesis within 6 months of screening;
    17. Unavailable for follow-up assessment or concern for subject´s compliance with the protocol procedures;
    18. Participation in a clinical trial of an investigational drug or device within 30 days prior to screening;
    19. Any other condition that in the opinion of the investigator renders the subject a poor risk for inclusion into the study. Examples of such conditions may include, but are not limited
    to, systemic lupus erythematosus, chronic obstructive lung disease and chronic pancreatitis.
    1. Embarazo o lactancia.
    2. Indicios de descompensación hepática en el pasado o en el presente, tales como ascitis, episodios de encefalopatía hepática, hemorragia varicosa o un TP/INR prolongado.
    3. ARN del VHC positivo.
    4. HBsAg positivo.
    5. Anticuerpos antimitocondriales positivos.
    6. Consumo de alcohol mayor de 21 oz/semana en los varones y 14 oz/semana en las mujeres.
    7. Colitis ulcerosa activa en el momento actual, definida como una puntuación parcial de la Clínica Mayo > 2, con una puntuación de hemorragias >0 o uso concomitante de corticosteroides, inmunomoduladores y/o inhibidores del factor de necrosis tumoral ? (TNF-?)
    8. Análisis toxicológico en orina positivo para anfetaminas, cocaína u opiáceos (por ejemplo, heroína o morfina) en el momento de la selección. Podrán participar en el estudio los pacientes en tratamiento de mantenimiento estable con metadona o buprenorfina durante al menos 6 meses antes de la selección. Los pacientes con un análisis toxicológico en orina positivo para medicamentos de venta con receta a base de opiáceos podrán participar en caso de que la prescripción y el diagnóstico sean revisados y aprobados por el investigador.
    9. Cardiopatía clínicamente importante.
    10. Antecedentes de colangiocarcinoma. Si se observa una estenosis dominante, deberá descartarse un colangiocarcinoma mediante citología por cepillado o biopsia antes de la aleatorización.
    11. Antecedentes de cáncer, excepto cáncer de piel distinto del melanoma, en los 5 años previos a la selección.
    12. Colangitis ascendente en los 60 días previos a la selección.
    13. Presencia de un drenaje percutáneo o endoprótesis de las vías biliares.
    14. Intervención de cirugía mayor en los 30 días previos a la selección o presencia de una herida abierta.
    15. Hipersensibilidad conocida al producto en investigación o a cualquiera de los excipientes de la formulación.
    16. Antecedentes de diátesis hemorrágica en los 6 meses previos a la selección.
    17. Indisponibilidad para la evaluación de seguimiento o preocupación por el cumplimiento de los procedimientos del protocolo por parte del paciente.
    18. Participación en un estudio de investigación de un fármaco o un producto sanitario en los 30 días previos a la selección.
    19. Cualquier otra situación que, en opinión del investigador, haga que el paciente corra un riesgo elevado en caso de participar en el estudio. Son ejemplos de tales situaciones, entre otras, el lupus eritematoso sistémico, la enfermedad pulmonar obstructiva crónica y la pancreatitis crónica.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be:
    Change from baseline in morphometric quantitative collagen on liver biopsy at Week 96.
    El criterio de valoración principal será:
    La variación con respecto al momento basal del colágeno cuantitativo morfométrico en la biopsia hepática en la semana 96.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Subjects will complete the 96 week treatment course with blinded study medication and will undergo liver biopsy at Week 96
    Los pacientes completarán el ciclo de tratamiento de 96 semanas con la medicación del estudio enmascarada y se someterán a una biopsia hepática en la semana 96
    E.5.2Secondary end point(s)
    Exploratory efficacy endpoints will include:
    - Change from baseline in morphometric quantitative collagen on liver biopsy at Week 48;
    - Change from Baseline in the Mayo risk score at 4 week intervals;
    - Change from Baseline in the MELD score at 4 week intervals;
    - Assess the rate of events related to progression of PSC in each treatment arm, including variceal bleeding, ascites, encephalopathy, ascending cholangitis, cholangiocarcinoma, hepatocellular carcinoma, transplant and death.
    - Change from Baseline in serum alkaline phosphatase levels at 4 week intervals;
    - Change from Baseline in the Ishak fibrosis stage on liver biopsy at weeks 48 and 96;
    - Change from Baseline in ?-smooth muscle actin on liver
    biopsy at weeks 48 and 96;
    - Change from Baseline on a VAS assessment of pruritus severity at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96;
    - Change from baseline in serum LOXL2 levels at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96;
    - Change from baseline in ELF? test at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96;
    - Change from baseline in FibroSURE/FibroTest/FibroMAX at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, and 96;
    - MRCP as compared to Baseline at weeks 48 and 96;
    - For a subset of approximately 50 subjects, change from baseline in liver stiffness as measured by MRE at weeks 48 and 96;
    - For a subset of approximately 50 subjects, change from baseline in liver stiffness as measured by impedance ultrasonography at weeks 48 and 96.
    Los criterios de valoración exploratorios serán los siguientes:
    - Variación con respecto al momento basal del colágeno cuantitativo morfométrico en la biopsia hepática en la semana 48.
    - Variación con respecto al momento basal del índice de riesgo de la Clínica Mayo a intervalos de 4 semanas.
    - Variación con respecto al momento basal de la puntuación MELD a intervalos de 4 semanas.
    - Evaluación de la tasa de acontecimientos relacionados con el curso de la CEP en cada grupo de tratamiento, como hemorragia varicosa, ascitis, encefalopatía, colangitis ascendente, colangiocarcinoma, carcinoma hepatocelular, trasplante y muerte.
    - Variación con respecto al momento basal de la concentración sérica de fosfatasa alcalina a intervalos de 4 semanas.
    - Variación con respecto al momento basal del estadio de fibrosis de Ishak en la biopsia hepática realizada en las semanas 48 y 96.
    - Variación con respecto al momento basal de la ?-actina del músculo liso en la biopsia hepática realizada en las semanas 48 y 96.
    - Variación con respecto al momento basal de la evaluación mediante EAV de la intensidad del prurito en las semanas 4, 8, 12, 24, 36, 48, 60, 72, 84 y 96.
    - Variación con respecto al momento basal de la concentración sérica de LOXL2 en las semanas 4, 8, 12, 24, 36, 48, 60, 72, 84 y 96.
    - Variación con respecto al momento basal de la prueba ELF? en las semanas 4, 8, 12, 24, 36, 48, 60, 72, 84 y 96.
    - Variación con respecto al momento basal en los resultados de FibroSURE/FibroTest/FibroMAX en las semanas 4, 8, 12, 24, 36, 48, 60, 72, 84 y 96.
    - CPRM con respecto al momento basal en las semanas 48 y 96.
    - En un subgrupo de aproximadamente 50 pacientes, variación con respecto al momento basal de la rigidez hepática determinada mediante ERM en las semanas 48 y 96.
    - En un subgrupo de aproximadamente 50 pacientes, variación con respecto al momento basal de la rigidez hepática determinada mediante ecografía de impedancia en las semanas 48 y 96.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoints:
    Subjects will complete the 96 week treatment course with blinded study medication and will undergo repeat liver biopsy at week 96. Other endpoints will be assessed at weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96 as detailed in each specific endpoint

    - For a subset of approximately 50 subjects, change from baseline in liver stiffness as measured by MRE at weeks 48 and 96;
    - For a subset of approximately 50 subjects, change from baseline in liver stiffness as measured by impedance ultrasonography at weeks 48 and 96.
    Criterios de valoración seecundarios:
    Los pacientes completarán el ciclo de tratamiento de 96 semanas con la medicación del estudio enmascarada y se someterán a una nueva biopsia hepática en la semana 96. Se evaluarán otros criteiros de valoración en las semanas 4, 8, 12, 24, 36, 48, 60, 72, 84 y 96, como se detalla en cada apartado específico.
    - En un subgrupo de aproximadamente 50 pacientes, variación con respecto al momento basal de la rigidez hepática determinada mediante ERM en las semanas 48 y 96.
    - En un subgrupo de aproximadamente 50 pacientes, variación con respecto al momento basal de la rigidez hepática determinada mediante ecografía de impedancia en las semanas 48 y 96.
    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 Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 EEA30
    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
    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 years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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: 225
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 225
    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)
    Gilead will provide no post trial treatment. Treatment following the trial will not be the standard offered to someone with their underlying disease and will be determined by the treating physician.
    Gilead no proporcionará ningún tratamiento posterior al ensayo. El tratamiento después del ensayo no será el estándar ofrecido a alguien con su enfermedad subyacente y será determinado por el médico que le trate.
    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 Decision2013-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 22:10:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA