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    Summary
    EudraCT Number:2016-001039-11
    Sponsor's Protocol Code Number:GA30044
    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:2016-10-26
    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 number2016-001039-11
    A.3Full title of the trial
    A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF GDC-0853 IN PATIENTS WITH
    MODERATE TO SEVERE ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS
    ESTUDIO EN FASE II, ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO DE LA SEGURIDAD Y LA EFICACIA DE GDC-0853 EN PACIENTES CON LUPUS ERITEMATOSO SISTÉMICO ACTIVO DE MODERADO A GRAVE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Safety and Efficacy of GDC 0853 in Patients With Moderate to Severe Active Systemic Lupus Erythematosus
    Estudio de seguridad y eficacia de GDC-0853 en pacientes con Lupus eritematoso sistémico activo de moderado a grave
    A.4.1Sponsor's protocol code numberGA30044
    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 SponsorGenentech, 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 supportGenentech Inc. c/o F. Hoffman-La Roche Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+34 91 325 73 00
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 nameGDC-0853
    D.3.2Product code RO7010939/F13
    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 INNnot available yet
    D.3.9.1CAS number 1434048-34-6
    D.3.9.2Current sponsor codeGDC-0853, RO7010939
    D.3.9.3Other descriptive nameGDC-0853 RO7010939
    D.3.9.4EV Substance CodeSUB181260
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Erythematosus
    Lupus eritematoso sistémico
    E.1.1.1Medical condition in easily understood language
    Systemic lupus erythematosus (SLE) is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue
    El lupus eritematoso sistémico (LES) es una enfermedad autoinmune en la que el sistema inmune ataca erróneamente alos tejidos sanos
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 the clinical efficacy of GDC-0853 in combination with standard of care (SOC)
    Evaluar la eficacia clínica de GDC-0853 en combinación con SOC
    E.2.2Secondary objectives of the trial
    •To evaluate the clinical efficacy of GDC-0853 over time using the Systemic Lupus Erythematosus Responder Index (SRI-4) as a standardized disease activity measure
    •To evaluate if patients with high plasmablast signature levels have an enhanced clinical response to GDC-0853 relative to patients with low levels
    •To evaluate the safety of GDC-0853 in combination with SOC therapy in patients with moderate to severe active SLE
    •To characterize the pharmacokinetics (PK) of GDC-0853 in patients using a population PK approach
    - Evaluar la eficacia clínica de GDC-0853 a lo largo del tiempo utilizando SRI-4 como medida estandarizada de la actividad de la enfermedad.
    - Evaluar si los pacientes con niveles elevados de huellas de plasmoblastos tienen una respuesta clínica aumentada a GDC-0853 en relación con los pacientes con niveles bajos.
    - Evaluar la seguridad de GDC-0853 en combinación con el tratamiento SOC en pacientes con LES activo de moderado a grave.
    - Caracterizar la farmacocinética de GDC-0853 en los pacientes con un enfoque FC de población
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18−75 years, inclusive
    - Fulfilment of SLE classification criteria according to either the current American College of Rheumatology (ACR) or Systemic Lupus International Collaborating Clinics (SLICC) criteria at any time prior to or at screening
    - At least one serologic marker of SLE at screening as follows: positive antinuclear antibody (ANA) test by immunofluorescent assay with titer >= 1:80; or positive anti-double-stranded DNA (anti-dsDNA) antibodies; or positive anti-smith antibody
    - At both screening and Day 1, moderate to severe active SLE, defined as meeting all of the following: Safety of Estrogen in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) score >=6 (with clinical SELENA-SLEDAI score >= 4.0); Physician’s global assessment >= 1.0 (out of 3); and currently receiving at least one standard oral treatment for SLE
    - If on an oral corticosteroids (OCS), the dose must be <= 40 mg/day prednisone (or equivalent,) and must have been stable for at least 2 weeks prior to screening as well as during screening
    - If on anti-malarial or immunosuppressive therapies, may only be receiving medications from the following list within the specified dose range; dose and route of administration must be stable for 8 weeks prior to screening as well as during screening:
    •Azathioprine: 1 to 2.5 mg/kg/day
    •Methotrexate: 7.5 to 25 mg/week
    •Mycophenolate mofetil: 500 to 2500 mg/day
    •Mycophenolic sodium: 360 to 1800 mg/day
    •Hydroxychloroquine: 200 to 400 mg/day
    •Chloroquine: 100 to 250 mg/day
    - For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the study treatment period and for a minimum of 60 days after the last dose of study drug or longer as required by local requirements for other standard of care medications
    - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm that together result in a failure rate of < 1% per year during the treatment period and for at least 120 days (16 weeks) after the last dose of study treatment
    - Tener de 18 a 75 años de edad, ambas inclusive.
    - Cumplir con los criterios de clasificación del LES de acuerdo a los criterios del Colegio Americano de Reumatología (American College of Rheumatology, ACR) o las Clínicas internacionales colaboradoras en el lupus sistémico (SLICC) en cualquier momento antes de o durante la selección.
    - Al menos un marcador serológico del LES en la selección, como se muestra a continuación: Prueba positiva de anticuerpos antinucleares (ANA) mediante un ensayo de inmunofluorescencia con un título >=1:80; o Anticuerpos positivos contra el ADN de doble hélice (ADNdh); o Anticuerpos positivos anti-Smith.
    - En la selección y en el día 1, presentar LES de moderado a grave, lo que se define como cumplir todos los criterios siguientes:Tener una puntuación de >=6 en la Evaluación nacional de seguridad de los estrógenos en lupus eritematoso e índice de actividad de la enfermedad para el LES (SELENA-SLEDAI) (con una puntuación clínica de la SELENA-SLEDAI de <=4,0); Evaluación global del médico de >=1,0 (de 3); y Recibir actualmente al menos un tratamiento oral estándar para el LES.
    - Si el paciente recibe un tratamiento de CO, la dosis debe ser <=40 mg/día de prednisona (o equivalente) y debe haberse mantenido estable durante al menos 2 semanas antes de la selección y durante la selección.
    - Si el paciente recibe un tratamiento antipalúdico o inmunodepresor,solo podr recibir medicamentos de la lista siguiente con la dosis indicada. La dosis y la vía de administración deben mantenerse estables durante las 8 semanas antes de la selección y durante la selección:
    * Azatioprina: de 1 a 2,5 mg/kg/día
    * Metotrexato: de 7,5 a 25 mg/semana
    * Micofenolato de mofetilo: de 500 a 2500 mg/día.*Micofenolato sódico: de 360 a 1800 mg/día
    *Hidroxicloroquina: de 200 a 400 mg/día.*Cloroquina: de 100 a 250 mg/día
    - En el caso de mujeres en edad fértil:aceptación de mantener la abstinencia sexual (evitar relaciones heterosexuales) o usar métodos anticonceptivos con un índice de fallo del < 1 % al año durante el periodo de tratamiento del estudio y durante un mínimo de 60 días tras la última dosis del fármaco del estudio, o más, según los requisitos locales para otros medicamentos de la práctica clínica habitual.
    - En el caso de los hombres: aceptación de mantener la abstinencia sexual (evitar relaciones heterosexuales) o usar medidas anticonceptivas y aceptar no donar esperma cuya combinación resulte en un índice de fallo del 1 % al año durante el periodo del tratamiento y durante al menos 120 días (16 semanas) tras la última dosis del tratamiento del estudio. Los varones deben abstenerse de donar esperma durante este mismo periodo
    E.4Principal exclusion criteria
    - Evidence of lupus nephritis
    - Neuropsychiatric or central nervous system lupus manifestations, including but not limited to: seizure, psychosis, or acute confusional state within 52 weeks of screening
    - Estimated glomerular-filtration rate < 30 mL/min or on chronic renal replacement therapy
    - History of receiving a solid organ transplant
    - Newly diagnosed (within the last 24 weeks) transverse myelitis
    - History of anti–phospholipid antibody syndrome with or without associated consumptive coagulopathy at any time; presence of anti-phospholipid antibodies or a history of fetal loss
    - Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB)
    - Significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system not related to SLE
    - Concomitant chronic conditions, in addition to SLE, (e.g., asthma, Crohn’s disease) that required oral, intravenous (IV), or intramuscular (IM) steroids or immunosuppressive use in the 24 weeks prior to screening or are likely to require these during the course of the study
    - History of non-gallstone−related pancreatitis or chronic pancreatitis
    - Evidence of autoimmune myositis
    - History of cancer, including hematological malignancy and solid tumors, within 10 years of screening
    - History of cerebrovascular accident (CVA), or spontaneous intracranial hemorrhage or a history of traumatic intracranial hemorrhage within 10 years or any history of hemorrhagic CVA
    - History of clinically uncontrolled cardiac arrhythmias; clinically significant ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as long QT syndrome or other genetic risk factors; structural heart disease; coronary heart disease; or family history of sudden unexplained death or cardiac ion channel mutations
    - Current treatment with medications that are well known to prolong the QT interval with the exception of chloroquine
    - Any condition possibly affecting oral drug absorption
    - Need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents
    - Known bleeding diathesis and any history of hospitalization or transfusion for a GI bleed
    - History of or currently active primary or secondary immunodeficiency, including known history of HIV infection or IgG < 500 mg/dL
    - History of recurrent bacterial, viral, mycobacterial, or fungal infections and any history of opportunistic infections assessed by Investigator
    - History of severe and/or disseminated viral infections, particularly herpes viruses, such as HSV1, HSV2, varicella zoster virus (VZV), cytomegalovirus
    - Evidence of chronic and/or active hepatitis B or C
    - Use of any of the medications, herbal supplements, or foods within 1 week or 5 half-lives, whichever is longer, prior to screening, on the basis of possible drug interactions with GDC-0853
    - Any uncontrolled, clinically significant, laboratory abnormality and ECG findings that would affect safety, interpretation of study data, or the patient’s participation in the study
    - Evidencia de lupus eritematoso
    -Manifestaciones de lupus en el sistema nervioso central o neuropsiquiátricas, incluidas, entre otras: crisis epiléptica, psicosis o estado de confusión agudo, en las 52 semanas previas a la selección.
    - Tasa de filtración glomerular estimada <30 ml/min o en el tratamiento de reemplazo renal crónico.
    - Antecedentes de recepción de un trasplante de órgano sólido.
    - Mielitis transversa recientemente diagnosticada (en las últimas 24 semanas)
    - Antecedentes de pancreatitis o pancreatitis crónica sin cálculos biliares
    -Pruebas de miositis autoinmune
    -Antecedentes de cáncer, que incluyen neoplasias hematológicas y tumores sólidos, en los 10 años previos a la selección
    -Antecedentes de accidente cerebrovascular (ACV) en los 10 años anteriores o cualquier antecedente de ACV hemorrágico
    - Cualquier antecedente de hemorragia intracraneal espontánea o antecedente de hemorragia intracraneal traumática en los 10 años anteriores
    -Antecedentes de arritmias cardíacas clínicamente no controladas; arritmias ventriculares clínicamente significativas o factores de riesgo de arritmias ventriculares, como síndrome de QT largo u otros factores de riesgo genético, cardiopatía estructural,cardiopatía coronaria o antecedentes familiares de muertes repentinas sin explicación o mutaciones en el canal iónico cardíaco
    - Tratamiento actual con medicamentos que se sabe que prolongan el intervalo QT, a excepción de la cloroquina
    - Cualquier afección que pueda afectar la absorción oral del fármaco
    - Necesidad de anticoagulación sistémica con warfarina, otros anticoagulantes orales o inyectables o agentes antiplaquetarios
    - Diátesis hemorrágica conocida o cualquier antecedente de hospitalización o transfusión por sangrado GI
    - Antecedentes de inmunodeficiencia primaria o secundaria o actualmente activa, incluidos los antecedentes conocidos de infección por el VIH o IgG < 500 mg/dl
    - Antecedentes de infecciones bacterianas, víricas, micobacterianas o fúngicas recurrentes o cualquier antecedente de infecciones oportunistas evaluada por el IP
    - Antecedentes de infecciones víricas graves y/o diseminadas, especialmente virus de herpes, como VHS1, VHS2, virus de la varicela zóster (VVZ), citomegalovirus
    - Evidencias de hepatitis B o C crónica y/o activa
    - El uso de cualquier otra medicación, suplementos de herboristería o alimentos contemplados a continuación o en el Manual de farmacia en 1 semana o 5 semividas antes de la selección , lo que sea más prolongado, sobre la base de las posibles interacciones farmacológicas con GDC-0853
    - Cualquier anomalía significativa no controlada clínicamente, resultados de laboratorio anormales y resultados ECG que pudiera afectar a la seguridad y a la interpretación de los datos del estudio, así como a la participación del paciente en el mismo
    E.5 End points
    E.5.1Primary end point(s)
    1. SRI-4 response at Week 48
    1. Respuesta SRI-4 en la semana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Week 48
    1. Semana 48
    E.5.2Secondary end point(s)
    1. SRI-4 response at Week 48 with a sustained reduction of OCS dose to < 10 mg/day and <= Day 1 dose during Week 36 through Week 48
    2. SRI-4 response at Week 24 with a sustained reduction of OCS dose to < 10 mg/day and <= Day 1 dose during Week 12 through Week 24
    3. SRI-4 response at Week 24
    4. Incidence of adverse events using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) scale to grade adverse events
    5. Changes in vital signs, physical findings, electrocardiogram (ECGs), and clinical laboratory results following GDC-0853 administration
    6. Area under the concentration time−curve from time 0 to time t (AUC0-t)
    7. Maximum concentration observed (Cmax)
    8. Time to maximum concentration (tmax)
    9. Steady-state concentration at the end of a dosing interval (Ctrough)
    10. Half-life (t1/2)
    11. Apparent clearance (CL/F)
    1.Respuesta SRI-4 en la semana 48 con una reducción constante de la dosis de CO a <10 mg/día y <=la dosis del día 1 durante la semana 36 hasta la semana 48
    - Respuesta SRI-4 en la semana 24 con una reducción constante de la dosis de CO a <10 mg/día y <= la dosis del día 1 durante la semana 12 hasta la semana 24
    - Respuesta SRI-4 en la semana 24
    4. Incidencia de acontecimientos adversos empleando la escala CTCAE del NCI para medir acontecimientos adversos.
    5. Cambios en las constantes vitales, los ECG y los resultados clínicos de laboratorio tras la administración de GDC-0853.
    6. ABC0-t  área bajo la curva de concentración-tiempo desde el momento 0 al momento t
    7. Cmáx  concentración máxima observada
    8. tmáx  tiempo hasta la concentración máxima
    9. concentraciónen estado estacionario al final de un intervalo de dosificación
    10. T1/2  semivida
    11. CL/F  aclaramiento aparente
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 48
    2-3. Week 24
    4-5. Up to 60 weeks
    6-11. Pre dose at Week 1, Week 4, Week 24, and Week 48; at unscheduled or flare or early termination visit
    1. Semana 48
    2-3. Semana 24
    4-5. Hasta semana 60
    6-11. Pre dosis en la semana 1 , semana 4, semana 24 y la semana 48 ; en la visita
    no programada o visita por exacerbación sin programar o visita de terminación anticipada
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 concerned5
    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
    Argentina
    Brazil
    Bulgaria
    Chile
    Colombia
    France
    Germany
    Korea, Republic of
    Mexico
    Portugal
    Spain
    Taiwan
    United Kingdom
    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
    The end of study is defined as the last patient, last safety follow-up visit in this protocol, last patient to discontinue from the study, or the last patient enrolled into an OLE, if initiated, whichever occurs latest.
    El final del estudio se define como el último paciente, la última visita de seguimiento de seguridad de este protocolo, el último paciente que interrumpa su participación en el estudio o, si se inicia, el último paciente inscrito en el estudio de OLE, lo que ocurra más tarde.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 240
    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)
    Patients who complete all study assessments may be screened for enrollment into an OLE study. If an extension study is initiated, patients will be required to meet all OLE eligibility criteria and enrollment must be considered appropriate, according to the investigator. Currently, it is not planned to provide GDC-0853 or any other study treatments/interventions to patients who have completed the study and are not qualified or elect not to enter an OLE study.
    Los pacientes que completaron todas las evaluaciones del estudio pueden ser valorados para la inscripción en un estudio OLE. Si se inicia un estudio de extensión, los pacientes tendrán que cumplir todos los criterios de elegibilidad OLE para que su inscripción pudiera considerarse. Actualmente, no está planeado suministrar GDC-0853 o cualquier otro tratamiento/intervención a los pacientes que hayan completado el estudio y no sean adecuados o elegidos para entrar en un estudio OLE.
    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 Decision2017-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-16
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    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.

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