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    Summary
    EudraCT Number:2007-000180-13
    Sponsor's Protocol Code Number:CLDT600A2409
    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:2011-02-03
    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 number2007-000180-13
    A.3Full title of the trial
    OPTIMA: A Randomized, Open-label, 156-week Treatment Study to
    Evaluate the Efficacy and Safety of Telbivudine or Tenofovir Treatment in
    HBeAg-negative Chronic Hepatitis B Patients Based on the Roadmap
    Concept
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Telbivudine or Tenofovir Treatment in HBeAg-negative Chronic Hepatitis
    B Patients Based on the Roadmap Concept (LDT600A)
    A.3.2Name or abbreviated title of the trial where available
    OPTIMA
    A.4.1Sponsor's protocol code numberCLDT600A2409
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01379508
    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 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 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 pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressHansastrasse 32
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80686
    B.5.3.4CountryGermany
    B.5.4Telephone number+496172789 7077
    B.5.5Fax number+496172789 8091
    B.5.6E-mailGabriele.Klockner@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.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 Information not present in EudraCT
    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.3.10 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Treatment in HBeAg-negative chronic hepatitis B patients
    E.1.1.1Medical condition in easily understood language
    Hepatitis is caused by hepatitis B virus (HBV). HBeAg is a viral protein.
    HBeAg negative CHB is major type of the disease in Western countries
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 the study is to compare the efficacy of Roadmap-Concept-based telbivudine treatment versus Roadmap-Concept-based tenofovir treatment in HBeAg-negative CHB patients. The rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 will be used for the comparison of the efficacy. The hypothesis is that the aggregated rate of HBV DNA <300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2).
    E.2.2Secondary objectives of the trial
    The key secondary objective of the study is to assess the antiviral
    efficacy, as evaluated by rate of patients achieving HBV DNA <300
    copies/mL (51 IU/mL) at Week 104, 156; and in patients who achieve
    HBV DNA, <300 copies/mL at Week 104, to assess the rate of patients
    with maintained HBV DNA, <300 copies/mL at Week 156.
    •To compare the eGFR change in telbivudine arm versus tenofovir arm
    over the course of the study
    • eGFR change (absolute and percentage) from baseline to Week 52,
    104, and 156 (by C-G, MDRD, CKD-EPI formula), for the overall
    population (based on treatment arms) as well as sub-populations of
    patients with renal function impairment at
    baseline (defined as baseline eGFR 60-90 mL/min/1.73m2, or 60-80
    mL/min/1.73m2)
    • The percentage of patients with abnormal baseline eGFR (60-90
    mL/min/1.73m2, or 60-80 mL/min/1.73m2) shifting to normal eGFR
    (>90 mL/min/1.73m2 ) at Week 52, 104, and 156
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Immune Modulatory Effects Substudy of CLDT600A2409
    E.3Principal inclusion criteria
    Documented compensated HBeAg negative CHB defined by all of the following:
    •Detectable serum HBsAg at the screening visit and at least 6 months prior to the screening visit
    •HBeAg negative at the screening visit with positive HBeAb
    •Serum HBV DNA > 2000 IU/mL, as determined by the COBAS Taqman HBV DNA PCR assay at the central laboratory at screening visit
    •Serum ALT level > 1×ULN and <10×ULN at screening visit. Patients with normal ALT ≤ 1xULN at screening are eligible if: 1) they have at least moderate liver inflammation or fibrosis; or 2) clinical evidence of compensated liver cirrhosis; or 3) ALT level > 1×ULN within the last 6 months (EASL guidelines 2009; Lok and McMahon 2009)
    •Available liver histology report within 12 months before screening with diagnosis of chronic hepatitis B.Patients without evaluable liver histology report within 12 months of screening are eligible if: 1) they have clinical evidence of compensated liver cirrhosis; or 2) non-invasive methods which are recommended by guidelines and updated clinical practice and that support diagnosis of moderate to severe liver inflammation and/or fibrosis (i.e. Fibroscan) (EASL guidelines 2009; Lok and McMahon 2009)
    E.4Principal exclusion criteria
    •Women of child-bearing potential, defined as all women physiologically
    capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
    •Sexually active males must use a condom during intercourse while taking study drug and for 12 days after stopping study medication and should not father a child in this period.
    •Patients co-infected with HCV, HDV, or HIV.
    •Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time.
    •Patient has received IFN or other immunomodulatory treatment within six months before the screening visit. Precluded therapies include, but are not limited to any exposure to interferons, Thymosin, IL-12, or any types of immunological therapy.
    •Patient has a medical condition that requires frequent use of systemic acyclovir or famcyclovir, etc.
    •Patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.
    •Patient has clinical signs/symptoms of hepatic decompensation with Child-Pugh score of B or C.
    •History of malignancy of any organ system
    •Patient has one or more additional known primary or secondary causes of liver disease, other than CHB, including steatohepatitis and autoimmune hepatitis among other liver diseases.
    •Patient is currently abusing illicit drugs, or has a history of illicit substance abuse within the preceding two years.
    •Patients with a history of alcohol abuse will be required to be abstinent from alcohol 6 months prior to screening or at the investigator’s discretion, and during the course of the study.
    •Patients without a history of alcohol abuse are required to have an alcohol consumption of ≤ 30g ethanol/day for men and ≤ 15g ethanol/day for women twice a week during the course of the study.
    •Patient has a history of clinical and laboratory evidence of chronic renal insufficiency defined as an estimated serum creatinine clearance < 50 mL/min using either Cockcroft-Gault or MDRD; or with a lower serum phosphate < 1.5 mg/dL.
    •Patient has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
    •Patient has a medical condition requiring the use of chemotherapy.
    •History of any other acute or chronic medical condition that in the opinion of the investigator would make the patient unsuitable for inclusion into the study.
    •Patient has any other concomitant medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
    •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
    •Patient has a history of myopathy, myositis, or persistent muscle weakness.
    •Patient has any of the following laboratory values during the screening period:
    •Hemoglobin ≤11 g/dL(110g/L) for men or ≤10 g/dL (100g/L) for women
    • Total WBC ≤3500/mm3 (3.5× 109 /L)
    • Absolute neutrophil count (ANC) ≤1,500/mm3 (1.5×109/L)
    • Platelet count ≤ 75,000/mm3 (75× 109 /L)
    • Serum amylases or lipase ≥ 2 × ULN

    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint is the rate of HBV DNA < 300 copies/mL at week 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 52
    E.5.2Secondary end point(s)
    The secondary objectives of the study are to assess the antiviral efficacy
    at Week 104, the rate of patients with maintained antiviral efficacy at
    Week 156 and eGFR changes at Week 52, 104 and 156.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 52, 104 and 156
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    - Immunology sub-study
    - Renal function exploratory study
    - Liver fibrosis exploratory study
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    Turkey
    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
    Study completion is defined for an individual patient who meets the
    screening requirements, attends the Baseline Day 1 visit, completes the 104 week Treatment Phase of the study and 4
    week Follow-up Phase of the study. The study recruitment is completed when at least 240 patients have been randomized to the treatment arms.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 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: 240
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 240
    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 Decision2011-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-10
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