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    The EU Clinical Trials Register currently displays   40995   clinical trials with a EudraCT protocol, of which   6701   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2004-003754-26
    Sponsor's Protocol Code Number:NV-02B-019
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-21
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-003754-26
    A.3Full title of the trial
    A Randomized, Double-Blind Trial of Telbivudine (LdT) versus Continued Lamivudine Treatment in Adults with Compensated Chronic Hepatitis B Who are Currently Receiving Lamivudine Treatment
    A.4.1Sponsor's protocol code numberNV-02B-019
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIdenix Pharmaceuticals, 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nametelbivudine
    D.3.4Pharmaceutical form 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 codeNV-02B
    D.3.9.3Other descriptive nameb-L-2’deoxythymidine, L-thymidine, LdT
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Zeffix
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Smith Kline
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLamivudine
    D.3.4Pharmaceutical form 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 INNLamivudine
    D.3.9.1CAS number 134678-17-4
    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) 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess antiviral efficacy (serum HBV DNA reductions) in hepatitis B patients
    randomly switched to telbivudine or continued on lamivudine treatment after 3-12
    months of previous treatment with lamivudine.
    E.2.2Secondary objectives of the trial
    To compare clinical efficacy outcomes. Clinical efficacy will be assessed by serum ALT normalization and a composite serologic efficacy endpoint termed Therapeutic Response (HBV DNA < 5 log10 copies/mL with HBeAg loss or ALT normalized). The number of patients with HBV DNA PCR negative and HBeAg responses (HBeAg loss and seroconversion) will be assessed in an exploratory fashion, in the patient subgroup who are HBeAg-seropositive at study entry.

    To compare clinical and laboratory safety observations.

    To characterize the frequency of viral breakthrough, and treatment-emergent HBV viral genotypes associated with viral breakthrough.

    The featured data analyses will be targeted to 12, 24, and 52 weeks after initiation of study treatment. The final data analysis is the Week 52 analysis.

    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria:
    Male or female, 18 to 70 years of age
    Documented compensated chronic hepatitis B defined by all of the following:
    • Clinical history compatible with compensated chronic hepatitis B
    • Detectable serum HBsAg at the Screening visit
    • HBeAg seropositive or seronegative
    • History of evidence of chronic liver inflammation, documented by previous history
    of elevated serum ALT and/or AST levels (at least two elevated ALT or AST values
    spanning six months or more, documented in available records), and/or chronic
    liver inflammation documented on previous liver biopsy with available pathology
    report.
    • Serum ALT level at Screen < 10 x ULN
    • Serum HBV DNA > 3 log10 copies/mL by the COBAS Amplicor HBV PCR assay at
    the central study laboratory
    Patient is currently receiving lamivudine treatment for his/her hepatitis B, and has
    received lamivudine continuously for a duration of at least 12 weeks (3 months) and
    not more than one year (12 months). The start of lamivudine therapy must be
    documented in the patient’s available medical records.
    Patient is willing and able to comply with the study drug regimen and all other study
    requirements.
    The patient is willing and able to provide written informed consent to participate in the study.
    E.4Principal exclusion criteria
    Patient is pregnant or breastfeeding.

    Patient is of childbearing potential (men and women) and unwilling to use a barrier
    method of contraception. It is required that a barrier method of contraception be
    used (i.e. condom with spermicide or diaphragm with spermicide) by patients of
    childbearing potential (men and women) regardless of whether a hormonal agent
    also is used as a method of contraception.

    Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or
    HIV-2. Patients will be tested for antibodies to HCV, HIV, and HDV in the
    Screening assessments performed at the central laboratory.

    Patient previously received antiviral treatment for hepatitis B other than lamivudine
    in the preceding 12 months. Precluded therapies include, but are not limited to,
    the following: interferon alpha-, beta-, or gamma-interferon), adefovir dipivoxil or
    other PMEA analogs (tenofovir, MCC-478), ganciclovir, ribavirin, entecavir, emtricitabine (FTC), L-FMAU, L-Fd4C, or other investigational anti-HBV
    nucleosides/nucleotides.

    Patient has received other systemic immunomodulatory treatment for HBV infection in the preceding 12 months. Precluded therapies include, but are not limited to any exposure to thymosin, IL-12, or other putative systemic immunomodulators.

    Patient has a medical condition that requires prolonged or frequent use of systemic
    acyclovir or famciclovir. Prolonged use means episodic treatment with these agents for periods exceeding 10 days every 3 months, or chronic suppressive therapy.
    A history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of hepatic decompensation.

    Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC, such as suspicious foci on imaging studies or elevated serum alpha-fetoprotein (AFP) levels. In patients with such findings, HCC should be ruled-out prior to randomization for the present study.

    Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse
    or illicit substance abuse within the preceding two years. For the purposes of the
    present study, alcohol abuse is defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40 g of ethanol. Patients
    currently on methadone maintenance treatment programs are NOT eligible for this
    study due to potential interference with study evaluations.

    Patient has a medical condition that requires frequent or prolonged use of systemic
    corticosteroids

    Patient has one or more additional known primary or secondary causes of liver
    disease, other than hepatitis B. Gilbert’s syndrome and Dubin-Johnson syndrome, two benign disorders associated with low-grade hyberbilirubinemia, will not exclude patients from participation in this trial. The presence of either of these two disorders should be so indicated on the appropriate page in the case report form.

    Patient has any other concurrent medical 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 (e.g., concurrent malignancies, history of unstable
    angina, repeated myocardial infarction or congestive heart failure, renal insufficiency, uncontrolled asthma or diabetes, unstable thyroid disease or other significant hormonal conditions, uncontrolled seizure disorders, severe psychiatric disorders, active tuberculosis under current treatment, etc.). A history of treated malignancy (other than hepatocellular carcinoma) is allowable if the patient’s malignancy has been in complete remission off chemotherapy and without additional surgical interventions during the preceding three years.

    Patient has a history of clinical pancreatitis.

    Patient is enrolled or plans to enroll in another clinical trial of an investigational
    agent while participating in this study.

    Patient has any of the following laboratory values at Screening:
    • Hemoglobin <11 g/dL for men or < 10 g/dL for women [Female <100 g/L;
    Male <110 g/L
    • Total WBC < 3,000/ mm3
    • Absolute neutrophil count (ANC) < 1,500/mm3 [<1.50 x 109/L]
    • Platelet count < 75,000/mm3 [<75 x 109/L]
    • Serum albumin < 3.3 g/dL [<33g/L]
    • Total bilirubin ≥ 2.0 mg/dl [ > 34 µmol/L]
    • Serum creatinine > 1.5 mg/dl [Female >106 µmol/L; Male >115 µmol/L]
    • AFP > 50 ng/mL [>50 µg/L] (requires further evaluation, to rule-out hepatocellular carcinoma)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be reduction from study Baseline in serum HBV DNA level,
    involving a comparison of results with telbivudine treatment (Group A) vs. continued
    lamivudine treatment (Group B).
    Featured data analyses on the primary endpoint and the secondary endpoints will
    occur at Weeks 12, 24, and 52. The main purpose of this interim analysis is to assure
    that continued pursuit of the scientific goals of the study is reasonable, by assessing
    whether the switch from lamivudine to telbivudine is, at least, not likely to produce any
    efficacy detriment for the patients. The principal treatment comparison on the primary
    endpoint will be the Week 24 comparison, with the Week 52 analysis considered to be confirmatory.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    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) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Lamivudine
    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.8.5The trial involves multiple Member States Yes
    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
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-02-21. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 230
    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 Decision2005-05-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-12-05
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