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    Summary
    EudraCT Number:2016-000785-37
    Sponsor's Protocol Code Number:GS-US-320-1092
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-25
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-000785-37
    A.3Full title of the trial
    A Randomized, Double-Blind Evaluation of the Pharmacokinetics, Safety, and Antiviral Efficacy of Tenofovir Alafenamide (TAF) in Children and Adolescents 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 understand the safety and effectiveness of a new drug called TAF for the treatment of long term hepatitis B infection in adolescents and children
    A.4.1Sponsor's protocol code numberGS-US-320-1092
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/274/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical trials mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Vemlidy
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameVemlidy
    D.3.2Product code J05AF13
    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.3.9.2Current sponsor codeGS-7340
    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: 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.3.1Product nameTenofovir Alafenamide
    D.3.2Product code GS-7340
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.2Current sponsor codeGS-7340
    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 number15
    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 placeboFilm-coated tablet
    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 placeboFilm-coated tablet
    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
    E.1.1.1Medical condition in easily understood language
    Long term infection with 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
    Cohort 1 (adolescents 12 to <18 years, ≥ 35 kg):
    -To evaluate the safety, tolerability and antiviral activity (HBV DNA < 20 IU/mL) of tenofovir alafenamide (TAF) 25 mg once daily versus placebo at Week 24 in adolescent subjects with chronic hepatitis B (CHB)

    Cohort 2 (children 2 to <12 years of age):
    Part A:
    -To evaluate the steady-state pharmacokinetics (PK) of TAF and TAF-metabolite tenofovir (TFV) and confirm the dose of TAF given once daily in children with CHB
    Part B:
    -To evaluate the safety and tolerability of TAF given once daily at Week 48 in children with CHB.
    -To evaluate the antiviral activity (HBV DNA < 20 IU/mL) of TAF given once daily versus placebo at Week 24 in children with CHB
    E.2.2Secondary objectives of the trial
    -To evaluate the safety and tolerability of TAF versus placebo at Week 24 in children with CHB
    -To evaluate the open-label safety of TAF given once daily at Week 48 in adolescents with CHB, and at Weeks 96 and 240 in adolescents and children with CHB
    -To evaluate the antiviral activity (HBV DNA < 20 IU/mL) of open-label TAF at Weeks 48, 96, and 240 in adolescents and children with CHB
    -To evaluate the serologic response (loss of HBeAg and seroconversion to anti-HBe, and loss of HBsAg and seroconversion to anti-HBs) of TAF versus placebo at Week 24, and of open-label TAF at Weeks 48, 96, and 240 in adolescents and children with CHB
    -To evaluate the biochemical response (ALT normalization) of TAF versus placebo at Week 24, and of open-label TAF at Weeks 48, 96, and 240 in adolescents and children with CHB
    -To evaluate the change in fibrosis as assessed by FibroTest® of TAF versus placebo at Week 24, and of open-label TAF at Weeks 48, 96, and 240 in adolescents and children with CHB
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Cohort 1 - Intensive PK Substudy (Optional)
    All enrolled subjects may take part in an optional Intensive PK substudy to be performed at either the Week 4 visit or the Week 8 visit. For those subjects who consent to participate in the PK substudy, blood, samples will be collected at 0 (pre-dose, ≤ 30 minutes prior to dosing), 15 minutes, 30 minutes, 1, 1.5, 2, 3, 4, 5, and 8 hours post-dose.
    E.3Principal inclusion criteria
    1) Males and non-pregnant, non-lactating females
    2) Age at Screening: 2 to < 18 years old
    3) Weight at Screening as follows:
    -Cohort 1: 12 years to < 18 years and ≥ 35 kg (≥77 lbs)
    -Cohort 2 (Group 1): 6 years to < 12 years and ≥ 25 kg (≥55 lbs)
    -Cohort 2 (Group 2): 6 years to < 12 years and ≥17 kg to < 25 kg (≥37 lbs to <55 lbs)
    -Cohort 2 (Group 3^): 2 years to < 6 years and <17 kg^^ (<37 lbs)^^
    ^Subjects unable to swallow a tablet
    ^^Body weight cutoff at Screening to be determined

    4) Willing and able to provide written informed consent/assent (child and parent/legal guardian)
    5) Documented evidence of CHB (e.g. HBsAg-positive for ≥ 6 months)
    6) HBeAg-positive, or HBeAg-negative, chronic HBV infection with all of the following:
    a) Screening HBV DNA ≥ 2 × 10000 IU/mL
    b) Screening serum ALT > 45 U/L (>1.5 × ULN; 30 U/L) and ≤ 10 × ULN (by central laboratory range)
    7) Treatment-naïve (defined as < 12 weeks of oral antiviral (OAV) treatment with any oral nucleos(t)ide analogue) OR treatment-experienced subjects (defined as subjects meeting all entry criteria [including HBV DNA and serum ALT criteria] and with ≥ 12 weeks of previous treatment with any nucleos(t)ide analogue) will be eligible for enrollment. All treatment-experienced subjects must have discontinued oral nucleos(t)ide therapy ≥ 16 weeks prior to screening to avoid ALT flare if randomized to the placebo arm.
    8) Any previous treatment with interferon (pegylated or non-pegylated) must have ended at least 24 weeks prior to the Baseline visit
    9) Estimated creatinine clearance (CLCr) ≥ 80 mL/min/1.73m^2 (using the Schwartz formula; = k × L/sCr) [(k is a proportionality constant: for adolescent females ≥ 12 years old, k = 0.55, and for adolescent males ≥ 12 years, k = 0.70); L is height in centimeters (cm); and sCr is serum creatinine (mg/dL)]
    10) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant)
    11) Must be willing and able to comply with all study requirements
    E.4Principal exclusion criteria
    1) Pregnant females, females who are breastfeeding or who believe they may wish to become pregnant during the course of the study
    2) Males and females of reproductive potential who are unwilling to use an “effective”, protocol-specified method(s) of contraception during the study. For a list of protocol-specified contraceptive methods, refer to Appendix 5.
    3) Coinfection with HCV, HIV, or HDV
    4) Evidence of hepatocellular carcinoma (Note: if screening alpha-fetoprotein [AFP] is < 50 ng/mL no imaging study is needed; however, if the screening AFP is > 50 ng/mL an imaging study is required)
    5) Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
    6) Abnormal hematological and biochemical parameters
    7) Chronic liver disease of non-HBV etiology (e.g., hemochromatosis, alpha-1 antitrypsin deficiency, cholangitis)
    8) Received solid organ or bone marrow transplant
    9) Currently receiving therapy with immunomodulators (e.g. corticosteroids), or immunosuppressants
    10) Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator
    11) Malignancy within the 5 years prior to screening. Subjects under evaluation for possible malignancy are not eligible.
    12) Known hypersensitivity to study drugs, metabolites, or formulation excipients.
    13) Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
    14) Subjects on prohibited concomitant medications. Subjects on prohibited medications, otherwise eligible, will need a wash out period of at least 28 days prior to the Baseline visit.
    15) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
    E.5 End points
    E.5.1Primary end point(s)
    The primary safety endpoints are:
    -Incidence of treatment-emergent serious adverse events (SAEs) and treatment-emergent adverse events in subjects treated with TAF or placebo at Week 24 (Cohort 1).
    -Incidence of treatment-emergent serious adverse events (SAEs) and treatment-emergent adverse events in subjects treated with TAF or placebo at Week 48 for 24 weeks followed by 24 weeks of open-label TAF (Cohort 2).

    The primary efficacy endpoint for all Cohorts is:
    -The percentage of subjects with plasma HBV DNA < 20 IU/mL at Week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 24, 48
    E.5.2Secondary end point(s)
    The secondary safety endpoints are:
    -Graded laboratory abnormalities, Tanner stage assessment, selected bone and renal safety parameters, including percentage change from Baseline in bone mineral density (BMD) of whole body minus head and lumbar spine performed by dual imaging x-ray absorptiometry (DXA) scan, and change in serum creatinine, and eGFR by the Schwartz formula method to evaluate the safety and tolerability of the treatment regimen at Weeks 24, 48, 96, and 240.
    -Incidence of treatment-emergent SAEs and treatment-emergent adverse events in subjects treated with TAF or placebo at Week 24 (Cohort 2).
    -Incidence of treatment-emergent SAEs and treatment-emergent adverse events in subjects treated with TAF or placebo for 24 weeks followed by open-label TAF at Week 48 (Cohort 1) and Weeks 96 and 240 (Cohorts 1 and 2)
    -Evaluation of glucose, phosphate, retinol-binding protein and beta-2-microglobulin at Weeks 4, 8, 12, 24 and 48 (Cohorts 1 and 2)

    The secondary efficacy endpoints are:
    -The percentage of subjects with plasma HBV DNA < 20 IU/mL at Weeks 48, 96, and 240
    -The proportion of subjects with plasma HBV DNA < 20 IU/mL (target not detected) at Weeks 24, 48, 96, and 240
    -The percentage of subjects with ALT normalization at Weeks 24, 48, 96, and 240
    -The percentage of subjects achieving the composite endpoint of both ALT normalization and HBV DNA < 20 IU/mL at Weeks 24, 48, 96 and 240
    -The change from Baseline in fibrosis as assessed by FibroTest® at Weeks 24, 48, 96, and 240
    -The percentage of subjects with HBeAg loss and seroconversion to anti-HBe at Weeks 24, 48, 96, and 240 (HBeAg-positive subjects only)
    -The percentage of subjects achieving the composite endpoint of both HBeAg seroconversion and HBV DNA < 20 IU/mL at Weeks 24, 48, 96, and 240 (HBeAg-positive subjects only)
    -The percentage of subjects with HBsAg loss and seroconversion to anti-HBs at Weeks 24, 48, 96, and 240
    -Incidence of resistance mutations at Weeks 24, 48, 96, and 240
    -Assessment of acceptability/palatability of study drug at Baseline, and Weeks 4, 24, and 36

    The primary PK endpoint for Cohort 2 is:
    -The PK parameter AUCtau for TAF

    The secondary PK endpoints for Cohorts 1 and 2 are:
    -PK parameters of AUClast, Cmax, Clast, Tmax, Tlast, λz, CL/F, Vz/F, and T1/2 for TAF and TFV,
    and AUCtau, and Ctau for TFV
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 24, 48, 96, and 240
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety 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) Yes
    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 trial5
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Hong Kong
    India
    Italy
    Korea, Republic of
    New Zealand
    Romania
    Russian Federation
    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
    last patient last visit (LPLV)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 150
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 75
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 75
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    adolescents, children
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 150
    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)
    none
    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 Decision2016-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-05
    P. End of Trial
    P.End of Trial StatusCompleted
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