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    Summary
    EudraCT Number:2005-005987-94
    Sponsor's Protocol Code Number:GAHB-Study
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-04-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-005987-94
    A.3Full title of the trial
    Double-blind placebo-controlled randomised trial of lamivudine in the treatment of acute hepatitis B
    A.3.2Name or abbreviated title of the trial where available
    GAHB-Study
    A.4.1Sponsor's protocol code numberGAHB-Study
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number07772084
    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 SponsorUniversity of Leipzig
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name Zeffix
    D.2.1.1.2Name of the Marketing Authorisation holderGSK
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameZeffix
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLamivudin
    D.3.9.1CAS number 159989-64-7
    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 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 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 placeboCapsule, hard
    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
    Acute Hepatitis B
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10059193
    E.1.2Term Acute hepatitis B
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Is time to bilirubin < 2mg/dl shortened by the treatment with lamivudine?
    E.2.2Secondary objectives of the trial
    - Is the time to clear HBV-DNA/HBeAg/HBsAg and/or development of anti-HBe/anti-
    HBs shortened by the treatment with lamivudine?
    - Is the rate of HBsAg positive patients at 6 resp. 12 month lowered by the
    treatment with lamivudine?
    - If initiallly abnormal: Is the time to normalization of prothrombin time (Quick ≥70%)
    and liver enzymes ALAT, ASAT shortened by the treatment with lamivudine?
    - Is the rate of patients progressing to fulminant hepatitis lowered by the treatment
    with lamivudine?
    - Is the rate of Adverse and Serious Adverse Events similar in both treatment arms?
    - For patients with ongoing employment relationship: Is the time to end of absence
    from work shortened by the treatment with lamivudine?

    In addition, the aspects of quality of life/physical capacity resp. health economics will be adressed within two independent sub-studies.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1.) Analysis of single nucleotide polymorphisms, 03.04.2006, final version:
    Objectives:
    Is there a difference in frequency for certain SNP in patients with acute vs. chronic hepatitis B?

    2.) Immune genetics in HBV, 03.04.2006, final version:
    Objectives:
    Are SNP on Chromosome 6 and 21 associated with severe acute hepatitis B?

    3.) Immunology in acute HBV infection, 03.04.2006, final version:
    Objectives:
    Is viral clearance associated with an immune response against HBsAg or HBcAg?

    4.) HBV-Genetics in acute HBV-Infection, 03.04.2006, final version:
    Objectives:
    To assess HBV variants (genotypes, precore ane basal core promotor, polymerase and preS/S-gene) as predictors for antiviral treatment efficacy in acute hepatitis B.

    5.) ASSESSMENT OF QUALITY OF LIFE
    Objectives:
    Is the quality of life impaired by acute hepatitis B, and does this impairment persist after viral clearance?

    6.) HEALTH ECONOMICS
    Objectives:
    Is treatment intervention with lamivudine cost effective?
    Economic evaluation of lamivudine in the treatment of acute hepatitis B.
    E.3Principal inclusion criteria
    - Acute hepatitis
    - HBsAg positive
    - Compensated liver function (Quick > 50%)
    - Bilirubin > 5mg/dl (i.e. >85µmol/l)
    - ALAT > 10 times upper normal range
    - Age >= 18 years
    - Time since diagnosis < 8 days
    - Written informed consent of the patient
    E.4Principal exclusion criteria
    - Known or obvious pre-existing liver disease (by e.g. spider naevis, ascites)
    - Ongoing interferon therapy or stop of interferon less than 3 months ago
    - Ongoing drug abuse
    - HIV positive
    - Anti-HCV or HCV-RNA positive
    - Anti-HDV positive
    - Renal insufficiency (creatinine >1.5mg/dl or 135µmol/l)
    - Pregnant or nursing women
    - Women with child bearing potential (< 2 years after last menstruation) without
    effective contraception
    - Use of oral contraception
    - Patient with transplanted organs
    - Any disease requiring immunosuppressive therapy, incl. cancer chemotherapy
    - Any acute infectious disease requires administration of sulphonamide/ trimethoprim
    - Evidence of any other disease, metabolic dysfunction, physical examination finding,
    or clinical laboratory finding giving reasonable suspicion of a disease or condition
    that contraindicates use of an investigational drug, or patient at high risk from
    treatment complications
    - Known hypersensitivity to any of the study drugs or its ingredients
    - Current or recent (within 30 days prior to start of trial treatment) treatment with
    another investigational drug or participation in another investigational trial
    - Expected low compliance (e.g. by travel distance to trial site)
    E.5 End points
    E.5.1Primary end point(s)
    Time until Bilirubin < 2 mg/dl
    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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 concerned75
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) Information not present in EudraCT
    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 Yes
    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 2006-04-25. Yes
    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 state140
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 140
    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 still HBsAg positive after 24 weeks of study therapy might be further treated openly with an antiviral drug at the discretion of 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 Decision2006-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-08
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