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    Summary
    EudraCT Number:2017-001110-29
    Sponsor's Protocol Code Number:56136379HPB2001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-02
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2017-001110-29
    A.3Full title of the trial
    A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)ide Analog in Subjects With Chronic Hepatitis B Virus Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)ide Analog in Subjects With Chronic Hepatitis B Virus Infection
    A.4.1Sponsor's protocol code number56136379HPB2001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03361956
    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 Sciences Ireland UC
    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 Sciences Ireland UC
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@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-56136379
    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 Assigned
    D.3.9.2Current sponsor codeJNJ-56136379-AAA
    D.3.9.4EV Substance CodeSUB180015
    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: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code JNJ-56136379
    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 Assigned
    D.3.9.2Current sponsor codeJNJ-56136379-AAA
    D.3.9.4EV Substance CodeSUB180015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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 fumarate
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeSUB12607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Baraclude
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 monohydrate
    D.3.9.1CAS number 209216-23-9
    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.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
    D.8 Placebo: 2
    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
    Chronic Hepatitis B Virus Infection
    E.1.1.1Medical condition in easily understood language
    A serious liver infection caused by the hepatitis B virus
    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 efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.
    E.2.2Secondary objectives of the trial
    • To evaluate the safety and tolerability of study treatment.
    • To evaluate efficacy in terms of changes in HBsAg levels.
    • To evaluate efficacy in terms of changes in HBV DNA levels.
    • To evaluate efficacy in terms of changes in HBeAg levels (in HBeAg-positive subjects only).
    • To evaluate efficacy in terms of HBsAg (in all subjects) or HBeAg (in HBeAg-positive subjects only) seroclearance and/or seroconversion.
    • To evaluate the frequency of subjects with biochemical response.
    • To evaluate the frequency of HBV virological breakthrough.
    • To evaluate the potential effect of JNJ-56136379 on the pharmacokinetics of
    nucleos(t)ide analog (NA) when coadministered.
    • To evaluate the pharmacokinetics of JNJ-56136379 when administered as monotherapy.
    • To evaluate the potential effect of NA on the pharmacokinetics of JNJ-56136379 when coadministered.
    • To assess changes in the HBV genome sequence.

    Additional objectives for treatment extension phase are in the protocol.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A separate liver biopsy substudy may be performed at selected study sites where a liver biopsy will be
    performed at different time points. Details, including objectives and study design, will be described in a separate substudy protocol.
    E.3Principal inclusion criteria
    1. Subjects must be 18 (or older legal age of consent as per local requirements) to 70 years of age, inclusive.

    2. Subjects must have a body mass index (weight in kg divided by the square of height in meters) of 18.0 to 35.0 kg/m2, extremes included.

    3. Criterion modified per Amendment 3
    3.1 Subjects must have CHB infection documented by:
    - Serum HBsAg-positive at screening and serum HBsAg- or HBV DNA positive at least 6 months prior to screening.
    - Serum IgM anti-HBc antibody negative at screening.

    4. In subjects currently not being treated (Treatment Arms 1-2-3 and 6-7-8):
    - Subjects must not be receiving any CHB treatment at screening, ie,
    o Have never received treatment with HBV antiviral medicines, including NAs or IFN products, OR
    o Have not been on treatment with HBV antiviral medicines, including NAs or IFN products within 6 months prior to baseline (first intake of
    study drugs), AND
    - Subjects must be HBeAg-positive and have HBV DNA ≥20,000 IU/mL,
    OR be HBeAg-negative and have HBV DNA ≥2,000 IU/mL at screening,
    AND
    - Subjects must have HBsAg >250 IU/mL at screening, AND
    - Subjects must have ALT > ULN and ≤5 x ULN at screening, determined in the central laboratory.

    Note: If subjects were treated with investigational anti-HBV agents more than 6 months before screening, the sponsor should be contacted to
    discuss the case. Subjects who have received treatment with a CAM for more than 4 weeks any time prior to screening are excluded.

    5. Criterion modified per Amendment 3
    5.1 In virologically suppressed subjects (Treatment Arms 4-5 and 9-10):
    - Subjects must be virologically suppressed by current NA treatment (ETV or TDF) as defined by HBV DNA <60 IU/mL at screening and at
    least 6 months prior to screening, AND
    - Subjects must be on the same NA treatment (ETV or TDF) and the same dose for ≥12 months prior to screening, AND
    - Subjects must have HBsAg >250 IU/mL at screening, AND
    - Subjects must have ALT ≤2x ULN at screening

    Note: If subjects were treated with investigational anti-HBV agents more than 6 months before screening, the sponsor should be contacted to
    discuss the case. Subjects who have received treatment with a CAM for more than 4 weeks any time prior to screening are excluded.

    Note: The current NA treatment can either be a branded product or a locally approved generic alternative (including different salt forms [eg, tenofovir maleate or succinate]). During the study, subjects will receive branded ETV (Baraclude®) or TDF (Viread®) treatment, as applicable.

    6. Subjects must have:
    - A liver biopsy result classified as Metavir F0-F2 within 1 year prior to screening or at the time of screening, OR
    - FibroScan™ liver stiffness measurement <8.0 kPa within 6 months prior to screening or at the time of screening.

    Note: Conventional imaging procedures (eg, conventional liver ultrasound, computed tomography [CT] or magnetic resonance imaging [MRI]) and serum marker panels are not allowed to rule out severe fibrosis or cirrhosis.

    7. Female subjects of childbearing potential must have a negative highly
    sensitive serum pregnancy test (beta-human chorionic gonadotropin) at
    screening.

    8. Female subjects must be:
    - Not of childbearing potential
    - Of childbearing potential and
    o Practicing a highly effective, preferably user-independent method of contraception (failure rate of <1% per year when used consistently and
    correctly) and agrees to remain on a highly effective method while receiving study treatment and until 90 days after last dose of JNJ- 56136379.

    Note: Female subjects of childbearing potential who are on a stable treatment regimen with hormonal contraceptives (ie, same dose and not
    starting or stopping hormonal contraceptive use) for ≥3 months prior to screening should continue the same dose regimen until 12 weeks after EOT. Ethinylestradiol-containing contraceptives are only allowed if the ethinylestradiol content is ≤20 μg. For female subjects of childbearing potential who will start a hormonal contraceptive treatment during the study, ethinylestradiol-containing contraceptives are not allowed. Please refer to Section 8 of the protocol.

    9. A female subject must agree not to donate eggs (ova, oocytes) during the study until at least 90 days after the last dose of JNJ-56136379.

    10. A male subject must agree to wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the
    study until at least 90 days after the last dose of JNJ-56136379.

    11. A male subject must agree not to donate sperm during the study and for at least 90 days after receiving the last dose of JNJ-56136379.

    12. Subject must sign an ICF 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 protocol for a full list of the inclusion criteria
    E.4Principal exclusion criteria
    1. Subjects who test positive for anti-HBs antibodies.

    2. Criterion modified per Amendment 3
    2.1 Subjects with current hepatitis A virus infection (confirmed by hepatitis A antibody IgM), HDV infection (confirmed by HDV antibody),
    hepatitis E virus infection (confirmed by hepatitis E antibody IgM), or HIV-1 or HIV-2 infection (confirmed by antibodies) at screening:
    subjects with a history of or current HCV infection (confirmed by HCV antibody). Evidence of other active infection (bacterial, viral, fungal, including acute tuberculosis) deemed clinically relevant by the investigator that would interfere with study conduct or its interpretation will also lead to exclusion.

    3. Subjects with any evidence of hepatic decompensation at any time
    point prior to or at the time of screening:
    - Direct bilirubin >1.2x ULN, or
    - International normalized ratio >1.5x ULN, or
    - Serum albumin < lower limit of normal (LLN), or
    - Documented history or current evidence of variceal bleeding, ascites, or hepatic encephalopathy.

    4. Subjects with any evidence of liver disease of non-HBV etiology. This includes but is not limited to hepatitis virus infections mentioned above,
    drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, Gilbert's syndrome, α-1 antitrypsin
    deficiency, primary biliary cirrhosis, primary sclerosing cholangitis, or any other non-HBV liver disease considered clinically significant by the
    investigator.

    5. Subjects who have signs of hepatocellular carcinoma (HCC) on an abdominal ultrasound performed within 2 months prior to screening or
    at the time of screening. In case of suspicious findings on conventional ultrasound, subject may still be eligible if HCC has been ruled out by a
    more specific imaging procedure (contrast enhanced ultrasound, CT or MRI).

    Additional exclusion criteria are listed in section 4.2 of the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in HBsAg levels at Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 24
    E.5.2Secondary end point(s)
    • Safety and tolerability data including but not limited to (S)AEs, physical examinations, vital signs, 12-lead ECGs, and clinical laboratory tests (including hematology, blood biochemistry, blood coagulation, and urinalysis) throughout the study.

    • Change from baseline in HBsAg levels during study treatment and follow-up.

    • Proportion of subjects with HBsAg levels by response subcategory, such as HBsAg <1,000 or <100 IU/mL, or with >0.5 or >1 log10 IU/mL reduction in HBsAg from baseline as detailed in the Statistical Analysis Plan (SAP) during study treatment and follow-up.

    • Change from baseline in HBV DNA levels during study treatment and follow-up.

    • Proportion of subjects with HBV DNA levels by response subcategory as detailed in the SAP during study treatment and follow-up.

    • Change from baseline in HBeAg levels during study treatment and follow-up.

    • Proportion of subjects with HBeAg levels by response subcategory as detailed in the SAP during study treatment and follow-up.

    • Proportion of subjects with HBsAg or HBeAg seroclearance (defined as HBsAg or HBeAg negativity, respectively, based on the assay used) during study treatment and follow-up.

    • Proportion of subjects with HBsAg or HBeAg seroconversion (defined as HBsAg or HBeAg negativity and anti-HBs or anti-HBe antibody positivity, respectively) during study treatment and follow-up.

    • Proportion of subjects with ALT improvement and normalization during study treatment and follow-up.

    • Proportion of subjects with virological breakthrough during study treatment defined as confirmed on-treatment HBV DNA increase by >1 log10 from nadir level or confirmed on-treatment HBV DNA level >200 IU/mL in subjects who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay.

    • Pharmacokinetics of NA when administered as monotherapy or when coadministered with JNJ-56136379.

    • Pharmacokinetics of JNJ-56136379 when administered as monotherapy or when coadministered with an NA.

    • Emergence of treatment-associated mutations during study treatment and follow-up.

    Please note: Endpoints applicable to the treatment extension phase only are listed in the protocol.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety: throughout the study

    HBsAg, HBeAg, HBV DNA: Screening, Treatment phase: Day 1, Weeks 1, 2, 4, 8, 12 (D84), 16, 20, 24, and Follow-up phase: Weeks 2, 4, 12, 24

    Anti-HBs and anti-HBe: Screening, Treatment phase: Day 1 and Week 24, and Follow-up phase: Weeks 2, 4, 12, 24

    PK samples: Treatment phase: Day 1, Weeks 1, 2, 4, 8, 12 (D84), 20, 24, and Follow-up phase: Weeks 2 and 4

    Blood chemistry (ALT): Screening, Treatment phase: Day 1, Weeks 1, 2, 4, 8, 12 (D84), 16, 20, 24, and Follow-up phase: Weeks 2, 4, 12, 24

    Viral genome sequencing: Screening, Treatment phase: Day 1, Weeks 2, 4, 8, 12 (D84), 16, 20, 24, and Follow-up phase: Weeks 2, 4, 12, 24

    Evaluations relating to the treatment extension phase of the study are described in the protocol.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker and Patient-Reported Outcome Analyses
    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 Yes
    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 trial10
    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 EEA38
    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
    Belgium
    Canada
    China
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Malaysia
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    Thailand
    Turkey
    Ukraine
    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
    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 days1
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days1
    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: 210
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 121
    F.4.2.2In the whole clinical trial 220
    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)
    The sponsor will provide treatment or care up to the end of follow up period in the trial only. Medical treatment care beyond the follow up period (i.e. after the end of participation in the trial) will be up to subject’s physician as per local/regional treatment guidelines and subject’s medical insurance.
    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 Decision2018-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-20
    P. End of Trial
    P.End of Trial StatusOngoing
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