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    Summary
    EudraCT Number:2010-019884-12
    Sponsor's Protocol Code Number:INFIRE-001
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-10-14
    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 number2010-019884-12
    A.3Full title of the trial
    Induction of Fibrosis Regression regarding Chronic Hepatitis B Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reducing liver fibrosis in patients with chronic Hepatitis B infection
    A.3.2Name or abbreviated title of the trial where available
    INFIRE
    A.4.1Sponsor's protocol code numberINFIRE-001
    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 SponsorUniversitätsklinikum Aachen
    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 supportBristol-Myers Squibb
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Aachen
    B.5.2Functional name of contact pointProf. Dr. med. Christian Trautwein
    B.5.3 Address:
    B.5.3.1Street AddressPauwelsstraße 30
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52074
    B.5.3.4CountryGermany
    B.5.4Telephone number+492418080866
    B.5.5Fax number+492418082455
    B.5.6E-mailctrautwein@ukaachen.de
    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 Baraclude
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    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 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 INNENTECAVIR
    D.3.9.1CAS number 142217-69-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with chronic hepatitis B infection and a relevant grade of fibrosis (histological >= F2)
    E.1.1.1Medical condition in easily understood language
    Hepatitis B Infection
    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
    Prospective evaluation of fibrosis regression for therapy with entecavir (Baraclude®) in patients with cHBV infection by means of non-invasive markers (FibroScan®, hyaluronic acid value) after 12 months
    E.2.2Secondary objectives of the trial
    -Prospective evaluation of fibrosis regression by means of procollagen III N peptide, TIMP-1 and YKL-40 after 12 months
    -Investigation of diagnostic accuracy (on the basis of sensitivity and speci-ficity) of the non-invasive markers (FibroScan®, serum parameters) with liver biopsy as gold standard
    -Evaluation of the proportional decrease in liver fibrosis after 6, 18, 24, and 36 months therapy with entecavir by means of FibroScan® and serum pa-rameters
    -Assessment of the anti-viral efficacy and safety of three years therapy with entecavir for fibrosis regression
    -Investigation of the relationship between fibrosis regression and the effi-cacy and kinetics of viral suppression with entecavir (Baraclude®)
    therapy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patients aged 18 to 75 years at the time of inclusion in the study
    •Written informed consent of the patient
    •Chronic hepatitis B infection (cHBV) with detectable HBV-DNA at study start
    •Availability of results from a recent liver biopsy. The date of the liver biopsy may not be more than six months before the day of the screen-ing visit.
    •Evidence for relevant liver fibrosis in the liver histology after percutane-ous or laparoscopic puncture (histologically >= F2) according to the as-sessment of an experienced pathologist and sufficient evaluability of the biopsy material (as a rule, evaluation of at least eight portal fields) or clinical evidence of a liver cirrhosis (on the basis of unequivocal endo-scopic or sonographic indications). The number of patients included with clinical evidence for a liver cirrhosis may not exceed 40%. After in-clusion of 40 patients (= 40%) with clinical evidence for a liver cirrhosis all study centres will be notified not to include more patients from this subgroup
    •Therapy indication according to the current guidelines for the cHBV infection (i.e. every virus replication in patients with liver cirrhosis or de-tection of an HBV-DNA >= 2000 IU/ml and/or liver histology with inflam-mation >= degree 2/ fibrosis >= stage 2 and ALT < 5 x ULN)
    •Non-pregnant (verified by a negative pregnancy test) and non-breast feeding women fulfilling at least one of the following criteria:
    -post-menopausal (12 months natural amenorrhea or six months amenorrhea with serum FSH > 40mlU/ml)
    -6 weeks after operative sterilisation by bilateral tubal ligation or bi-lateral ovarectomy with or without hysterectomy
    -Correct use of two methods for reliable contraception. This includes any combination of a hormonal contraceptive (pill, intra-uterine spi-ral, depot injection, hormone implant, hormone patch or vaginal ring) or an intra-uterine device with spermicidal barrier contracep-tive agent (diaphragm, cervical cap, lea contraceptivum, femidom or condom) or a spermacide
    -Sexual abstinence from two weeks before the first administration of the investigational medicinal product (IMP), during the entire dura-tion of the study, and 30 days following the study, covering the elimination of the IMP
    -Patients with only female sexual partners
    -Male partner of a patient who is sterile before inclusion of the fe-male patient in the study and is the only sexual partner of the fe-male patient
    E.4Principal exclusion criteria
    •Anamnestically known hypersensitivity to Baraclude® or its components or to medication with a similar chemical structure
    •Participation of the patient in another clinical study within the last four weeks before inclusion or simultaneous participation in another clinical study
    •Anamnestically known addictive or other disorders, which do not allow the person to assess the nature, impact and possible consequences of the clinical study
    •Indications that the patient will probably not comply with the study pro-tocol (e.g. lack of willingness to co-operate)
    •Anamnestically known co-infection with hepatitis C, hepatitis D or HIV
    •Evidence for a hepatocellular carcinoma
    •Severe chronic disease with an estimated survival prognosis of less than three years
    •Any previous therapy with lamivudine or telbivudine or previous therapy within the last six months before inclusion in the clinical study with an-other active anti-viral drug
    •Contra-indications for taking entecavir
    •Creatinine clearance < 50ml/min and/or need for haemodialysis
    •MELD Score > 15 points and/ or evidence for ascites
    E.5 End points
    E.5.1Primary end point(s)
    Co-primary endpoints:
    Change in the liver stiffness measurement (LSM) value measured with the FibroScan® and the hyaluronic acid value after 12 months therapy with entecavir (Baraclude®)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 month
    E.5.2Secondary end point(s)
    1. Change in the serum parameters procollagen III N peptide, TIMP-1 and YKL-40 after 12 months
    2. Sensitivity and specificity of the FibroScan and the serum parameters compared with baseline with the result of the liver biopsy as gold standard
    3. Change in the LSM value (from the FibroScan®) and the serum pa-rameters after 6, 18, 24 and 36 months
    4. Reduction of HBV-DNA and the fraction of patients with non-detectable HBV-DNA at the different study visits (6, 12, 18, 24 and 36 months)
    5. Fraction of patients with ALT normalisation at the different study vis-its (6, 12, 18, 24 and 36 months)
    6. Fraction of patients with HBeAg loss, anti-HBe sero-conversion, HBsAg loss and anti-HBs sero-conversion at the different study visits 6, 12, 18, 24 and 36 months)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 12 month
    2. 12 month
    3. 6, 18, 24 and 36 months
    4.-6. 6, 12, 18, 24 and 36 months
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned10
    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 No
    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
    see protocol
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state100
    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)
    see 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 Decision2010-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-11-30
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