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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:2009-009214-40
    Sponsor's Protocol Code Number:A8121014
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-009214-40
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FILIBUVIR PLUS PEGYLATED INTERFERON ALFA-2A AND RIBAVIRIN IN TREATMENT NAÏVE, HCV GENOTYPE 1 INFECTED SUBJECTS
    A.4.1Sponsor's protocol code numberA8121014
    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 SponsorPfizer Inc, 235 East 42nd Street, New York, NY 10017
    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 No
    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 nameFILIBUVIR
    D.3.2Product code PF-00868554
    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 INNFilibuvir
    D.3.9.1CAS number 877130-28-4
    D.3.9.2Current sponsor codePF-00868554
    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 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 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
    Treatment of chronic HCV genotype 1 infection.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10019752
    E.1.2Term Hepatitis C virus (HCV)
    E.1.2System Organ Class 10022891 - Investigations
    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 for this study is to determine if the addition of filibuvir to a SOC regimen of pegIFN/RBV significantly increases the proportion of subjects who achieve a sustained viral response at the end of study (SVR; defined as the proportion of subjects with an undetectable plasma HCV RNA at Week 72) compared to pegIFN/RBV therapy alone.
    E.2.2Secondary objectives of the trial
    Secondary objectives include determination of the following :

    •Proportion of subjects in Path 2 only with undetectable HCV RNA at Weeks 4 (rapid viral response (RVR)), 12 (early viral response (EVR)), 24 and 48.
    •Proportion of subjects with undetectable HCV RNA 12 weeks following the completion of therapy (SVR12).
    •Proportion of subjects in Path 1 only with undetectable HCV RNA 24 weeks following the completion of therapy (SVR24).
    •Proportion of subjects with breakthrough or relapsed viremia in each treatment arm.
    •Assess the safety, tolerability and pharmacokinetics of filibuvir administered in combination with pegIFN and RBV.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A8121014, Semen sub-study , 02 September 09
    A PARALLEL GROUP SUB-STUDY TO ASSESS THE EFFECT OF FILIBUVIR ON SEMEN AND REPRODUCTIVE HORMONE PARAMETERS IN TREATMENT NAÏVE, MALE HCV GENOTYPE 1 INFECTED SUBJECTS
    Objective
     To evaluate the effects of filibuvir (300 or 600 mg BID) administered in combination with SOC therapy compared to SOC therapy alone on semen parameters in treatment naïve, male HCV genotype 1 infected subjects.

    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Male or female subjects at least 18 years of age.
    2.A negative pregnancy test at Screening and immediately prior to start of study medication for Women of Child Bearing Potential (WOCBP).

    NOTE: WOCBP includes any female who has experienced menarche and who has not undergone hysterectomy, bilateral oophorectomy or tubal ligation or is not post‑menopausal (aged >45, amennorheic for >2 years, and serum FSH levels >30 IU/L). Even women who are using mechanical products (intrauterine devices; barrier methods) to prevent pregnancy, who are practicing abstinence, or who have a partner that is sterile (eg, vasectomy), should be considered to be of child bearing potential.

    3. Willingness to utilize effective barrier contraception for WOCBP, males and their
    partners, throughout the duration of the study and for at least 7 months following the last dose of study medication. In addition, WOCBP must use another acceptable
    method of contraception from screening to at least 6 months after the trial.
    Acceptable contraception includes highly effective intrauterine devices or
    vasectomised partner. NOTE: oral, transdermal, implantable, or injectable hormone
    therapy is NOT allowed.

    4. HCV seropositive.
    5. HCV RNA ≥10,000 IU/mL at screening.
    6. HCV Genotype 1. Subjects infected with a non-genotype 1 strain or mixed genotypes are not eligible.
    7. Treatment naïve (no prior treatment with IFN-alpha+/- RBV regimens or investigational anti-HCV agents).
    8. Liver biopsy within two years (24 months) of Screening with non-cirrhotic fibrosis classification (Ishak score ≤4 or equivalent). A copy of the pathology report must be available at the study site prior to randomization. For those subjects with liver biopsy outside of the time window or for those subjects with no history of liver biopsy, a biopsy must be performed prior to randomization.
    9. Ultrasound within 6 months of Screening for 1) those subjects with bridging fibrosis or 2) those subjects with alpha-fetoprotein (AFP) >50 and <100 ng/mL with no evidence of hepatocellular carcinoma. For those subjects with an ultrasound conducted outside the 6-month time window, an ultrasound must be performed prior to randomization.
    10. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    11. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the trial:
    1. Co-infection with either HIV or HBV.
    2. Infection with a non-genotype 1 strain of HCV or mixed genotypes.
    3. Evidence of severe or decompensated liver disease, as evidenced but not
    limited to by any of the following at Screening:
    a. Child-Pugh score >6;
    b. Total serum bilirubin >2.5X ULN and direct bilirubin >1.5X ULN;
    c. Serum albumin <2.0 g/dL;
    d. Prothrombin time >1.5X ULN or INR >2.0X ULN;
    e. AST or ALT >10X ULN;
    f. History of ascites, bleeding varices, hepatic encephalopathy or hepatocellular carcinoma.
    4. Subjects with liver disease unrelated to HCV infection including but not limited to:
    a. Hemochromatosis;
    b. Genetic liver disease:
    1. Alpha-1 antitrypsin deficiency;
    2. Wilson’s disease.
    c. Auto-immune disease;
    1. Auto-immune hepatitis;
    2. Auto-immune cholestatic disease.
    d. Drug induced liver disease (history of ingestion of drugs known to produce hepatic steatosis including corticosteroids, high-dose estrogens, methotrexate, tetracycline or amiodarone in the previous 6 months;
    e. Cholestatic liver disease; bile duct obstruction;
    f. Alpha-fetoprotein (AFP) levels greater than 100 ng/ml;
    g. Malignant neoplastic disease;
    5. Pre-existing medical condition that makes the subject unsuitable for treatment with pegIFN alpha/RBV therapy per product labeling including, but not limited to:
    a. Ocular abnormalities such as retinopathy, cotton wool spots, optic nerve
    disorders, retinal hemorrhage; etc.
    b. Major psychiatric disorders (severe depression, schizophrenia, psychosis, or a history of a suicide attempt).
    6. Laboratory abnormality at Screening that makes the subject unsuitable for treatment
    with pegIFN alpha/RBV therapy per product labeling including, but not limited to:
    a. HbA1c >8.5%;
    b. Estimated creatinine clearance of <50 mL/min;
    c. Thyroid-stimulating hormone >1.2 x ULN or <0.8 x LLN (euthyroid subjects
    exempt if euthyroid function is confirmed by T4/T3 testing);
    d. ANA >1:640;
    e. Hematologic abnormalities: hemoglobin <12 g/dL (women) or <13 g/dL (men),
    platelet count <120,000 cells/mm3, and/or neutrophil count <1,500 cells/mm3;
    7. Abnormal ECG suggestive of clinically significant cardiac disease or QTc >450 msec at screening.
    8. History of solid organ transplant.
    9. Contraindicated medications being taken by the subject at the time of randomization that must be continued during the study period, including potent CYP3A4 inhibitors, sensitive CYP3A4 substrates, CYP3A4 substrates with narrow therapeutic range and CYP3A4 inducers.

    10. Have the following reproductive hormones outside the specified normal limits (males only):

    Total Reference Range(Conventional) Reference Range (SI)
    Testosterone 1.75-7.81 ng/mL 6.07-27.10 nmol/L
    LH 2.0-12.0 mIU/mL 2.0-12.0 IU/L
    FSH 1.13-12.51 mIU/mL 1.13-12.51 IU/L
    11. Active alcohol or substance abuse sufficient, in the Investigator’s judgment, to prevent adherence to study medication and/or follow-up;
    12. Pregnant or nursing females;
    13. Males whose female partner is pregnant;
    14. Unwilling or unable to comply with the Lifestyle guidelines (eg, no active drug or alcohol abuse);
    15. Participation in other studies within 30 days before the current study begins and/or during study participation;
    16.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    NOTE: Subjects with laboratory values outside of the criteria specified above may be retested once only. If upon retest a laboratory value is within 10% of the criteria listed above, the investigator may consider the subject for enrolment so long as the laboratory value is not considered by the investigator to be clinically significant.

    E.5 End points
    E.5.1Primary end point(s)
     Proportion of subjects with undetectable HCV RNA at Week 72 (SVR).
    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 Yes
    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
    Tolerability
    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) 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 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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 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
    In Protocol
    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 months9
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days26
    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.1.3Elderly (>=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 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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 111
    F.4.2.2In the whole clinical trial 288
    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)
    Subjects assigned to Arm C (PBO + pegIFN/RBV) with undetectable HCV RNA at the end of treatment (Wk 24 or 48) but who subsequently relapse with HCV RNA detectable during the follow-up period will be discontinued from the study. These subjects will be eligible to enter a rollover study and receive open label filibuvir + pegIFN/RBV for a further 48 Wks. All other subjects after completing their participation in the trial will receive treatment 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 Decision2009-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-27
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