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    Summary
    EudraCT Number:2008-005709-20
    Sponsor's Protocol Code Number:TMC435350-TiDP16-C202
    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:2008-11-21
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2008-005709-20
    A.3Full title of the trial
    An open-label trial in genotype 2, 3, 4, 5 and 6 hepatitis C-infected subjects to evaluate the antiviral activity, safety, tolerability and pharmacokinetics of TMC435350 following 7 days once daily dosing as monotherapy.
    A.4.1Sponsor's protocol code numberTMC435350-TiDP16-C202
    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 SponsorTibotec Pharmaceuticals
    B.1.3.4CountryBelgium
    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 nameTMC435350 or R494617
    D.3.2Product code TMC435350 or R494617, formulation F007
    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 INNnot assigned yet
    D.3.9.1CAS number 923604-59-5
    D.3.9.2Current sponsor codeTMC435350
    D.3.9.3Other descriptive nameR494617 or JNJ-38733214-AAA
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatitis C virus (HCV)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10019751
    E.1.2Term Hepatitis C virus
    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 this trial is to determine the antiviral activity of TMC435 during 7 days q.d. dosing at 200 mg as monotherapy in treatment naïve, genotype 2 to 6 HCV-infected subjects.
    E.2.2Secondary objectives of the trial
    The secondary objective of this trial is to determine the safety, tolerability and pharmacokinetic profile of TMC435 during 7 days q.d. dosing at 200 mg as monotherapy in treatment naïve, genotype 2 to 6 HCV-infected subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria to be eligible for this trial:
    1. Male and female subjects aged between 18 and 70 years, extremes included.
    2. Subjects with documented chronic (diagnosis of hepatitis C > 6 months before the
    screening period) genotype 2, 3, 4, 5 or 6 HCV infection (confirmed at screening)
    Note: HCV-infected subjects with hemophilia may be enrolled.
    3. HCV treatment-naïve subjects (not receiving or having received any treatment including investigational treatment for HCV with the exception of non-hepatoxic herbal remedies)
    4. Patients with either no cirrhosis or up to Child Pugh A (compensated cirrhosis) liver disease.
    5. HCV plasma viral load of ≥ 100,000 IU/mL at screening (as assessed by the Taqman assay).
    6. Informed Consent Form (ICF) signed voluntarily before the first trial related activity.
    7. Able to comply with the protocol requirements and having good accessible veins.
    8. Normal weight as defined by a Body Mass Index (BMI: weight in kg divided by the square of height in meters) of 18 to 32 kg/m2, extremes included.
    E.4Principal exclusion criteria
    1. Evidence of Child Pugh B or C liver disease at screening; evidence of decompensated liver disease defined as prior or current history of ascites, hepatic encephalopathy, esophageal or gastric varices.
    2. Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to hepatitis B, drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis.
    3. Subjects with diagnosed or suspected hepatocellular carcinoma.
    4. Subjects (male or women of childbearing potential) not agreeing to use highly effective birth control methods i.e. two separate forms of contraception, from screening through 90 days after the last dose of TMC435 and to continue if applicable (i.e. when continuing on SoC treatment) as dictated by the approved product information of the medication administered. For details see paragraph 5.2.4.
    5. Use of herbal medications, dietary supplements and products containing Hypericum perforatum (e.g. St. John’s wort) in a period of 14 days before the first trial medication intake until end of pharmacokinetic assessments (96 h post last dose of study medication).
    6. History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the Investigator’s opinion would compromise the subject’s safety and/or compliance with the trial procedures (period of non-drug/alcoholic misuse must at least be 1 month before the first administration of trial medication).
    7. A positive urine drug test at screening. Urine will be tested to check the current use of amphetamines, cocaine, and opioids (with the exclusion of methadone or equivalents).
    8. Subjects with at least one of the following laboratory abnormalities as defined by the Division of Microbiology and Infectious Diseases (DMID) Adult Toxicity Table (see
    Section 7.2, Addendum 2) at screening:
    - Bilirubin > 1.25x upper limit of laboratory normal range (ULN) (when accompanied
    by any increase in other liver function test) or > 1.5 x ULN (when other liver functions are in the normal range)
    - Platelet count < 90,000/mm3;
    - White blood cell (WBC) count < 2,000 cells/mm3;
    - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) grade 4;
    - Any other lab toxicity found to be clinically significant by the Investigator.
    Note: Retesting of abnormal screening values that lead to exclusion will be allowed once using an unscheduled visit during the screening period.
    9. Subjects coinfected with human immunodeficiency virus type 1 or 2 (HIV-1 or HIV-2), or hepatitis A or B virus infection (confirmed by hepatitis A antibody immunoglobulin [IgM], or hepatitis B surface antigen [HBsAg]) or active tuberculosis at screening.
    10. Subjects with any active clinically significant disease (e.g., cardiac dysfunction,
    cardio(myo)pathy, cardiac insufficiency, pancreatitis, renal insuffiency), or medical history or physical examination or electrocardiogram (ECG) findings during screening that, in the Investigator’s opinion, would compromise the outcome of the trial.
    11. Subjects having uncontrolled/unstable diabetes, active epilepsy or history of epilepsy, history of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalization or prior suicidal attempt.
    12. Subjects enrolled in another clinical trial within 90 days prior to screening.
    E.5 End points
    E.5.1Primary end point(s)
    Determine the antiviral activity of TMC435
    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 No
    E.6.6Pharmacokinetic Yes
    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
    antiviral activity, tolerability
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 months6
    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 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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 40
    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:
    - section 2 flowchart after last drug intake
    - section 5.1.1 overview of trial
    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 Decision2008-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-02-18
    P. End of Trial
    P.End of Trial StatusCompleted
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