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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-004942-14
    Sponsor's Protocol Code Number:CLDT600A2306
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-06-09
    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 number2012-004942-14
    A.3Full title of the trial
    A randomized, double-blind, 104-weeks treatment study to evaluate the efficacy, safety, tolerability and pharmacokinetics of telbivudine oral solution and tablets in children and adolescents with compensated HBeAg-positive and negative chronic hepatitis B virus infection
    P/119/2010
    P/203/2011
    P/236/2012
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of efficacy and safety, tolerability and pharmacokinetics of telbivudine in children and adolescents with compensated chronic hepatitis B virus infection
    A.4.1Sponsor's protocol code numberCLDT600A2306
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/111/2008
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointHassan Gandjini
    B.5.3 Address:
    B.5.3.1Street Address27-35, rue Victor Hugo
    B.5.3.2Town/ cityIvry sur Seine Cedex
    B.5.3.3Post code94853
    B.5.3.4CountryFrance
    B.5.4Telephone number+33380451 201
    B.5.6E-mailHassan.Gandjini@ppdi.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 Sebivo
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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 nameSebivo
    D.3.2Product code LDT600
    D.3.4Pharmaceutical form Oral solution
    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 INNTELBIVUDINE
    D.3.9.1CAS number 3424-98-4
    D.3.9.2Current sponsor codeLDT600
    D.3.9.4EV Substance CodeSUB25231
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Sebivo
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm 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 nameSebivo
    D.3.2Product code LDT600
    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 INNTELBIVUDINE
    D.3.9.1CAS number 3424-98-4
    D.3.9.2Current sponsor codeLDT600
    D.3.9.4EV Substance CodeSUB25231
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 placeboOral solution
    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
    compensated HBeAg-positive and negative chronic hepatitis B virus infection
    E.1.1.1Medical condition in easily understood language
    Liver infection caused by hepatitis B virus in children and adolescents
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    The primary objective of this study is to demonstrate the antiviral efficacy of telbivudine compared to placebo in pediatric patients (2- < 18 years) by determining the percentage of patients achieving serum HBV DNA level of <300 copies/mL at Week 24.
    E.2.2Secondary objectives of the trial
    - Antiviral efficacy as evaluated by the proportion of patients achieving HBV DNA< 300 copies/mL at Week 52 and Week 104
    - Biochemical response at Week 24, 52 and 104 as evaluated by proportion of patients whose baseline ALTs were abnormal and subsequently normalized
    - Serological response at Week 24, 52 and 104 (HBeAg loss; HBeAg seroconversion and HBsAg loss and HBsAg seroconversion)
    - Percentage of patients achieving composite endpoints at Week 52 and 104 (HBV DNA < 300 copies/mL, ALT normalization and HBeAg seroconversion)
    - Cumulative rate of Virological Breakthrough at Week 52 and 104
    - Presence of genotypic resistance in VB and non-responders patients at Week 24
    - Safety assessments (SAEs, AEs, AESI (muscle related events), hepatic decompensation or HCC, chemistry or hematology abnormalities
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A signed informed constent/assent must have been obtenined from
    both parents or legal guardian(s) before any assessment is performed
    2. Male or female out-patients between 2 and < 18 years of age (at time
    of randomization), except in the Republic of South Korea, where children
    aged 2 years to < 12 years only (at time of randomization) will be
    enrolled
    3. Clinical history compatible with compensated chronic hepatitis B
    4. Documented compensated chronic hepatitis B defined by the following:
    a) Positive serum HBsAg at screening and at least one other documentation of HBsAg positive at least 6 months prior to screening
    b) For HBeAg positive patients at screening, significant biologic signs of disease activity following EASL guidelines recommendations for CHB pediatric patients (Sokal et al 2013)
    i) serum HBV DNA level ≥ 5 log10 copies/mL (COBAS Taqman®) (or 20
    000 IU/mL) at screeningas assesed by central laboratory and
    ii) serum ALT ≥ 1.5×ULN and < 10×ULN (pediatric ULN) either once
    during the screening period or twice (2 times)within 6 months prior to
    screening
    c) For HBeAg negative patients at screening, significant biologic signs of disease activity following EASL guidelines recommendations for CHB pediatric patients (Sokal et al 2013)
    i) serum HBV DNA level ≥ 4 log10 copies/mL (COBAS Taqman®) or 2000 IU/ml at screening as assessed by the central laboratory and
    ii) serum ALT ≥ 1.0 ×ULN and < 10×ULN (pediatric ULN) either once during the screening period or twice (2times) within 12 months prior to screening
    5. Patients and parent (or legal guardian) are willing to comply with the
    study drug regimen and all other study requirements.
    6. Patient meeting criteria for treatment according to local guidelines.
    E.4Principal exclusion criteria
    •Patients with acute or chronic infection of HCV, HDV, HIV, or with acute infection of HAV, HEV, CMV, or EBV.
    •Patient has received treatment of interferon or any other immunomodulatory agents within the last 12 months prior to screening or any nucleoside or nucleotide drugs or other anti-CHB treatment (approved or investigational) at any time before screening
    •Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir, systemic corticosteroids (topical and inhaled corticosteroids are allowed).
    • Patient has a decompensated liver disease defined as a Child-Turcotte-Pugh (CTP) Score ≥7 (Class B or C).
    •Patient has one or more additional known primary or secondary causes of liver disease, other than infectious agents, including alcoholic or nonalcoholic liver disease, fatty liver,
    hepatobiliary disease, Wilson disease and alpha-1 antitrypsin deficiency, Gilbert's syndrome, Dubin-Johnson syndrome etc.
    • Liver transplant recipient. Organ or bone marrow transplant recipients.
    • Patient is currently abusing illicit drugs, or has a history of illicit substance abuse.
    • All patients are required to be abstinent from alcohol during the course of the study otherwise excluded.
    • Patient has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs or chemotherapy
    • History of any other acute or chronic medical condition ( including congenital diseases, metabolic diseases, malignant diseases, neurological disorders, nephrotic diseases, pancreatitis, autoimmune disorders, diabetes, etc.)that in the opinion of the investigator would make the patient unsuitable for inclusion into the study.
    •Patient has a history of myopathy, myositis, persistent muscle weakness or persistent high serum CK levels (≥7×ULN), any muscular disease including but not limited to congenital / metabolic etiology, or with abnormal neuromuscular signs at screening or any screening CK
    values suggestive of muscular disease, or age at which independent walking time first achieved after 16 months of age (based on birthday).
    •Patient receiving any drugs potentially associated with myopathy within 3 months prior to screening
    •Any other clinical significant disease, condition or abnormality, unrelated to their HBV infection at screening, as assessed by the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to demonstrate the antiviral efficacy of telbivudine compared to placebo in pediatric patients (2 - < 18 years) by determining the percentage of patients achieving serum HBV DNA level of <300 copies/mL at Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    1.anti-viral efficacy at Week52 and Week104
    2. Biochemical response (ALT normalization) at Week 24, Week 52 and Week 104
    3.Serological response at Week 24, Week 52 and Week 104
    4. Composite endpoint (HBV DNA undetectability, ALT normalization and HBeAg seroconversion) at Week 52 and Week 104
    5. Cumulative rate of Virological Breakthrough at Week 52 and 104
    6. Presence of genotypic resistance in VB and non-responders patients at Week 24 ( or who discontinued before Week 24)
    7. safety endpoints (SAEs, AEs, Grade 3-4 AEs and AEs related to study drug, AESI (muscle related events), hepatic decompensation or HCC, Grade 3-4 chemistry or hematology abnormalities
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 24, 52, 104
    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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Bulgaria
    Greece
    Israel
    Korea, Republic of
    Romania
    Taiwan
    Turkey
    Ukraine
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    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 state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    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)
    Patients who complete the study treatment period enter into the 12 weeks post-treatment follow-up phase (also called Safety Follow-up). It is up to the investigator’s discretion to decide on the requirement of additional HBV treatment based on local practice guidelines after study completion. The Sponsor will make all effort to supply post-study provision of telbivudine until marketing authorization is received, as
    permitted by local law and regulation and as determined by the investigator.
    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 Decision2014-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-01-09
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