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    Summary
    EudraCT Number:2007-003704-35
    Sponsor's Protocol Code Number:GS-US-174-0115
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-30
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2007-003704-35
    A.3Full title of the trial
    A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Adolescents with Chronic Hepatitis B Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test the effectiveness and safety of Viread in adolescents with long lasting Hepatitis B Infection.
    A.3.2Name or abbreviated title of the trial where available
    GS-US-174-0115
    A.4.1Sponsor's protocol code numberGS-US-174-0115
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/180/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGilead Science Incorporated
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences Inc
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address333 Lakeside Drive
    B.5.3.2Town/ cityFoster City
    B.5.3.3Post codeCA 94404
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16505743000
    B.5.5Fax number+16505789264
    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 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.3.1Product nameViread
    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.3.10 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.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
    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 lasting infection with 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 15.0
    E.1.2Level LLT
    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 compare the antiviral efficacy, safety and tolerability of tenofovir DF 300 mg once daily versus placebo once daily in adolescents (aged 12–17 years) with chronic hepatitis B infection
    E.2.2Secondary objectives of the trial
    • To evaluate the biochemical and serological responses to tenofovir DF versus placebo in adolescents with chronic hepatitis B infection
    • To evaluate the incidence of drug resistance mutations
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female
    • 12 through 17 years of age, inclusive (consent of parent/legal guardian required)
    • Documented chronic HBV infection, defined as positive serum HBsAg ≥ 6 months
    • HBeAg-positive or HBeAg-negative (a maximum of 50% of subjects may be HBeAg-negative)
    • Weight ≥ 35 kg
    • Able to swallow oral tablets
    • HBV DNA ≥10(5) copies/mL (PCR method)
    • ALT ≥ 2 × ULN at screening, OR any history of ALT ≥ 2 × ULN over the past ≤ 24 months
    • Willing and able to provide written informed consent/assent (child and parent/legal guardian)
    • Negative serum β-HCG pregnancy test (for post-menarchal females only)
    • Estimated glomerular filtration rate (creatinine clearance) ≥ 80 mL/min/1.73m2
    • Adequate hematologic function (absolute neutrophil count ≥ 1,500/mm3; hemoglobin ≥ 10.0 g/dL)
    • No prior tenofovir DF therapy (subjects may have received prior interferon or oral anti-HBV nucleoside/nucleotide therapy; subjects must have discontinued interferon therapy ≥ 6 months prior to screening; subjects experienced on anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm)





    E.4Principal exclusion criteria
    • Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
    • Sexually-active males and females of reproductive potential who are not willing to use an effective method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
    • Decompensated liver disease defined as direct (conjugated) bilirubin > 1.2 x ULN, PT > 1.2 x ULN, platelets < 150,000/mm3, serum albumin < 3.5 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage).
    • Receipt of interferon (pegylated or not) therapy within 6 months of the Screening Visit
    • Receipt of anti-HBV nucleoside/nucleotide therapy within 16 weeks of the Screening Visit
    • α-fetoprotein > 50 ng/mL
    • Evidence of hepatocellular carcinoma (HCC)
    • Co-infection with HIV, HCV, or HDV
    • History of significant renal disease (e.g., nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal disease)
    • History of significant bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures)
    • Significant cardiovascular, pulmonary or neurological disease
    • Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications
    • History of solid organ or bone marrow transplantation
    • Ongoing therapy with any of the following:
    - Nephrotoxic agents
    - Chronic daily non-steroidal anti-inflammatory drug therapy
    Administration of any of the above medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period.
    • Known hypersensitivity to the study drugs, the metabolites or formulation excipients
    • Any other condition (including alcohol or substance abuse) 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 efficacy endpoint is HBV DNA < 400 copies/mL at Week 72. A long-term evaluation of efficacy intention-to-treat algorithm will be employed for handling missing data; the details of this algorithm will be included in a separate statistical analysis plan.

    The primary safety endpoint is cumulative incidence of at least a 6% decrease from baseline in bone mineral density of the spine through Week 72.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 72
    E.5.2Secondary end point(s)
    For Week 72, secondary endpoints to be evaluated in all subjects include:
    • ALT normal,
    • composite endpoint of HBV DNA < 400 copies/mL and ALT normal,
    • HBV DNA < 169 copies/mL,
    • HBsAg loss and seroconversion,
    • cumulative incidence of at least a 6% decrease from baseline in bone mineral density of whole body,
    • percent change from baseline in bone mineral density of spine,
    • percent change from baseline in bone mineral density of whole body,
    • change in Z-score for bone mineral density of spine,
    • change in Z-score for bone mineral density of whole body, and
    • development of drug resistance mutations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 72.

    At Weeks 48 and 192, secondary efficacy endpoints include all of the endpoints at Week 72, including HBV DNA < 400 copies/mL. Of note, Week 48 endpoints will not be analyzed prior to the primary efficacy analysis at Week 72, and Weeks 96 and 144 endpoints will not be analyzed prior to the Week 192 efficacy analyses.
    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 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) No
    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 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 trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Turkey
    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 when the last subject has completed the Week 192 visit and is 18 years of age or older. Subjects 17 years of age or younger at the Week 192 visit will be offered continuation in an extension of the study where they will receive open-label tenofovir DF (300 mg) until they have reached 18 years of age.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 106
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 106
    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 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 75
    F.4.2.2In the whole clinical trial 100
    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 study treatment will end after the each subject reaches Week 192. At Week 192, all active subjects will be offered tenofovir DF through a roll-over protocol until it becomes commercially available for the indication and age group studied in this protocol
    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 Decision2008-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-02
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