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    Summary
    EudraCT Number:2021-002450-81
    Sponsor's Protocol Code Number:73763989PAHPB2007
    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:2021-08-05
    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 number2021-002450-81
    A.3Full title of the trial
    A Phase 2, Open-label, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection.
    Plataforma: “Estudio Plataforma para evaluar la eficacia y seguridad de las intervenciones en pacientes con infección crónica de hepatitis B”
    Apéndice específico de intervención: “Estudio de fase 2, abierto, multicéntrico para evaluar la eficacia, seguridad, Tolerabilidad y farmacocinética del tratamiento con JNJ-73763989, análogos de núcleos(t)ido e Interferón alfa-2a pegilado en pacientes con infección crónica por el virus de la hepatitis B”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Treatment With JNJ-73763989, Nucleos(t)ide Analogs, and Pegylated Interferon Alpha-2a in Patients With Chronic Hepatitis B Virus Infection.
    Estudio clínico para evaluar la eficacia, seguridad, tolerabilidad y farmacocinética del tratamiento con JNJ-73763989, análogos de nucleos(t)ido e interferón pegilado alfa-2a en pacientes con infección crónica por el virus de la hepatitis B.
    A.3.2Name or abbreviated title of the trial where available
    The PENGUIN-2 Study
    Estudio PENGUIN-2
    A.4.1Sponsor's protocol code number73763989PAHPB2007
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research and Development LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJANSSEN CILAG, S.A.
    B.5.2Functional name of contact pointGlobal Development
    B.5.3 Address:
    B.5.3.1Street AddressPº de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917228000
    B.5.5Fax number0034917228628
    B.5.6E-mailebellonm@its.jnj.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 JNJ-73763989
    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 INNNot yet assigned
    D.3.9.2Current sponsor codeJNJ-73763989
    D.3.9.3Other descriptive nameJNJ-73763989
    D.3.9.4EV Substance CodeSUB197801
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Entecavir Mylan 0.5 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderMylan S.A.S.
    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 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 INNEntecavir
    D.3.9.3Other descriptive nameENTECAVIR MONOHYDRATE
    D.3.9.4EV Substance CodeSUB25434
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 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 Viread 245 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    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 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 INNTENOFOVIR DISOPROXIL
    D.3.9.3Other descriptive nameTENOFOVIR DISOPROXIL
    D.3.9.4EV Substance CodeSUB20643
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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: 4
    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 Vemlidy 25 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    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 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 INNTENOFOVIR ALAFENAMIDE
    D.3.9.1CAS number 379270-37-8
    D.3.9.3Other descriptive nameTENOFOVIR ALAFENAMIDE
    D.3.9.4EV Substance CodeSUB121761
    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: 5
    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 Pegasys 180 micrograms solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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 Solution for injection in pre-filled syringe
    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 INNPEGINTERFERON ALFA-2A
    D.3.9.1CAS number 198153-51-4
    D.3.9.3Other descriptive namePEGINTERFERON ALFA-2A
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number360
    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 Yes
    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 B Virus Infection
    Infección crónica por el virus de la hepatitis B
    E.1.1.1Medical condition in easily understood language
    Chronic Hepatitis B Virus Infection
    Infección crónica por el virus de la hepatitis B
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10008910
    E.1.2Term Chronic hepatitis B
    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 evaluate the efficacy in terms of HBsAg changes from baseline for the treatment regimens.
    Evaluar la eficacia, en términos de cambio de HBsAg desde la visita basal para las pautas de tratamiento.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability of the study intervention.
    2. To evaluate the efficacy of the study intervention during the follow-up period.
    3. To evaluate the efficacy of the study intervention as measured by blood markers during the study intervention and follow-up (FU) period.
    4. To evaluate the frequency of virologic breakthrough throughout the study.
    5. To evaluate the PK of JNJ-3989, and optionally of NA and PegIFN-α2a.
    1. Evaluar la seguridad y tolerabilidad del tratamiento del estudio.
    2. Evaluar la eficacia del tratamiento del estudio durante el periodo de seguimiento.
    3. Evaluar la eficacia del tratamiento del estudio determinada a partir de marcadores sanguíneos durante el tratamiento del estudio y el periodo de seguimiento.
    4. Evaluar la frecuencia de recaída virológica a lo largo del estudio.
    5. Evaluar la farmacocinética (FC) de JNJ-3989 y, opcionalmente, de AN y PegIFN-α2a.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A01. Adult male or female participants ≥18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive.
    M02. Participants must be medically stable based on physical examination, medical history, vital signs, and 12-lead ECG performed at screening.
    A03. Participants must have chronic HBV infection.
    M04. Participants must have a body mass index between 18.0 and 35.0 kg/m2, extremes included.
    A05. Participants must sign a Master ICF and must sign the ICF specific for this intervention cohort, indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.

    Please refer to the study protocol for a full list of inclusion criteria.
    A01. Pacientes adultos varones o mujeres ≥18 (o la mayoría de edad en la jurisdicción en la que tenga lugar el estudio) hasta 65 años inclusive.
    M02. Estar clínicamente estable de acuerdo con la exploración física, la historia clínica, las constantes vitales y el ECG de 12 derivaciones efectuado en la selección.
    A03. Tener una infección crónica por el VHB.
    M04. Tener un índice de masa corporal entre 18,0 y 35,0 kg/m2, ambos incluidos.
    A05. Firmar un DCI general y un DCI específico para esta cohorte de tratamiento donde se indique que comprenden el objetivo y los procedimientos necesarios del estudio y están dispuestos a participar en este.

    Por favor, consulte el protocolo del estudio para ver la lista completa de criterios de inclusión.
    E.4Principal exclusion criteria
    A01. Participants with evidence of hepatitis A virus infection, HCV infection, hepatitis D virus infection, hepatitis E virus infection, or HIV-1 or HIV-2 infection at screening.
    A02. Participants with evidence of hepatic decompensation at any time point prior to or at the time of screening.
    M03. History or evidence of clinical signs or symptoms of hepatic decompensation.
    M04. Participants with evidence of liver disease of non-HBV etiology.
    A05. Participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities.

    Please refer to the study protocol for a full list of exclusion criteria.
    A01. Tener indicios de infección por el virus de la hepatitis A, infección por el VHC, infección por el virus de la hepatitis D (VHD), infección por el virus de la hepatitis E o por el VIH-1 o VIH-2 en la selección.
    A02. Mostrar indicios de descompensación hepática en cualquier momento antes de la selección o en el momento de esta.
    M03. Tener antecedentes o evidencias de signos o síntomas clínicos de descompensación hepática.
    M04. Mostrar indicios de enfermedad hepática de etiología no relacionada con el VHB.
    A05. Tener antecedentes o signos de cirrosis o hipertensión portal o signos de carcinoma hepatocelular (CHC) o anomalías renales de relevancia clínica.

    Por favor, consulte el protocolo del estudio para ver la lista completa de criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with an HBsAg level <100 IU/mL at Week 24.
    Proporción de pacientes con un nivel de HBsAg <100 UI/ml en la semana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24.
    Semana 24.
    E.5.2Secondary end point(s)
    1. Safety and tolerability including but not limited to the proportion of participants with (S)AEs and abnormalities in clinical laboratory tests, 12-lead ECGs, vital signs, and ophthalmic and physical examinations throughout the study.

    2a. Proportion of participants with HBsAg seroclearance at FU Week 24 and 48 without re-starting NA treatment.
    2b. Proportion of participants with HBV DNA <LLOQ at FU Week 24 and 48 without re-starting NA treatment.
    2c. Frequency of virologic and/or biochemical flares.
    2d. Proportion of participants requiring NA re treatment.

    3a. Proportion of participants with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs over time.
    3b. Proportion of participants with HBsAg seroconversion.
    3c. Change from baseline over time in HBsAg.
    3d. Time to achieve HBsAg seroclearance/ seroconversion, and/or HBV DNA <LLOQ.

    4. Proportion of participants with virologic breakthrough.

    5a. PK parameters of JNJ-3989.
    5b. Optionally, PK parameters of NA and/or PegIFN-α2a.
    1. La seguridad y tolerabilidad incluyen, entre otras cosas, la proporción de pacientes con AA(G) y anomalías en las pruebas analíticas clínicas electrocardiogramas (ECG) de 12 derivaciones, constantes vitales y exploraciones físicas y oftalmológicas durante todo el estudio.
    2a. Proporción de pacientes con aclaramiento sérico de HBsAg en las semanas 24 y 48 del periodo de seguimiento sin reanudar el tratamiento con AN.
    2b. Proporción de pacientes con unos niveles de ADN del VHB <límite inferior de cuantificación (LIC) en las semanas 24 y 48 del periodo de seguimiento sin reanudar el tratamiento con AN.
    2c. Frecuencia de exacerbaciones víricas o bioquímicas.
    2d. Proporción de pacientes que precisan la reanudación del tratamiento con AN.
    3a. Proporción de pacientes con niveles de HBsAg, HBeAg, ADN del VHB y ALT superiores o inferiores a ciertos límites a lo largo del tiempo.
    3b. Proporción de pacientes con seroconversión de HBsAg.
    3c. Cambio a lo largo del tiempo de HBsAg desde el momento de referencia.
    3d. Tiempo hasta lograr el aclaramiento sérico/seroconversión del HBsAg o ADN del VHB <LIC
    4. Proporción de pacientes con recaída virológica.
    5a. Parámetros FC de JNJ-3989.
    5b. Opcionalmente, parámetros FC de AN o PegIFN-α2a.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study.
    Durante toda la duración del estudio.
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    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 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 EEA13
    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
    Hong Kong
    Japan
    Korea, Republic of
    Russian Federation
    Taiwan
    Thailand
    United States
    Poland
    Spain
    United Kingdom
    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
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days27
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 97
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 5
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 102
    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)
    Participants will be instructed that study intervention will not be made available to them after they have completed/discontinued study intervention and that they should return to their primary physician to determine standard of care.
    Se informará a los participantes que el tratamiento del estudio no estará disponible para ellos después de que hayan completado/discontinuado la intervención del estudio y que deben volver a su médico de cabecera para determinar el tratamiento médico a seguir.
    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 Decision2021-10-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-29
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