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    Summary
    EudraCT Number:2011-000653-23
    Sponsor's Protocol Code Number:TMC207-TiDP13-C210
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-05-15
    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 ConcernedEstonia - SAM
    A.2EudraCT number2011-000653-23
    A.3Full title of the trial
    A Phase III placebo-controlled, double-blind, randomized trial to evaluate the efficacy and safety of TMC207 in subjects with sputum smear-positive pulmonary infection with multi-drug resistant Mycobacterium tuberculosis (MDR-TB)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of TMC207 in patients with pulmonary infection with multi-drug resistant Mycobacterium tuberculosis
    A.4.1Sponsor's protocol code numberTMC207-TiDP13-C210
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation PlanP/55/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Infectious Diseases BVBA
    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 supportJanssen Infectious Diseases BVBA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV - Clinical Registry Group
    B.5.2Functional name of contact pointJanssen Biologics BV
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31(0)71524 2166
    B.5.5Fax number+31(0)71524 2110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/05/314
    D.3 Description of the IMP
    D.3.1Product nameTMC207 (as fumarate salt), R403323
    D.3.2Product code F001
    D.3.4Pharmaceutical form 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 INNN/A
    D.3.9.1CAS number 845533-86-0
    D.3.9.2Current sponsor codeTMC207
    D.3.9.3Other descriptive nameR403323
    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) 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
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Multi-drug resistant tuberculosis
    E.1.1.1Medical condition in easily understood language
    Tuberculosis
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10044755
    E.1.2Term Tuberculosis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate that TMC207 added to a BR is superior to this BR plus placebo in regard to the proportion of subjects with favourable treatment outcome 60 weeks after randomization (i.e., 36 weeks of treatment and 24 weeks of treatment-free follow-up).
    A favourable treatment outcome requires confirmed culture conversion at Week 60.
    E.2.2Secondary objectives of the trial
    For the secondary objectives please refer to chapter 2.1.2 of the Clinical Trial Protocol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosed with sputum smear-positive pulmonary Mycobacterium multi-drug resistant tuberculosis; including pre-extensively drug resistant TB, and positive for acid fast bacilli on direct smear examination of expectorated or induced sputum specimen (>=1+ smear positive within the preceding 3 weeks) at screening and also on Day-1.
    E.4Principal exclusion criteria
    - Has TB infection that has been demonstrated prior to randomization to be extensively drug resistant
    - Has a clinically significant active medical condition such as, but not limited to, hepatic, pancreatic, renal, cardiovascular, gastrointestinal, hematologic, neurologic, locomotor, immunologic, ophthalmologic (e.g.,corneal opacification or ulcers, uveitis, chorioretinitis), metabolic (except stable diabetes based on the
    investigator’s judgement), endocrine, oncological disease, muscular disease (e.g., myositis, rhabdomyolysis), or psychiatric, dermatological illness, or any other illness that the investigator considers should exclude the patient or that could interfere with the interpretation of the study results
    E.5 End points
    E.5.1Primary end point(s)
    Number of patients with favorable treatment outcome at Week 60
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 60
    E.5.2Secondary end point(s)
    1- Number of patients with confirmed culture conversion at Week 84
    2- Number of patients with confirmed culture conversion at Week 60 or at time of trial discontinuation
    3- The number of patients with development of pre-extensively drug-resistant
    tuberculosis and extensively drug-resistant tuberculosis
    4- Time to sputum culture conversion
    5- Number of patients with negative culture and smear for tuberculosis
    6- Time to positive signal in Mycobacteria Growth Indicator Tube (MGIT960)
    7- Number of patients with confirmed culture conversion by lung cavity status
    8- Number of patients with confirmed culture conversion by geographic region
    9- Number of patients with confirmed culture conversion by human immunodeficiency virus status
    10- Number of patients with confirmed culture conversion by baseline resistance to antituberculosis therapy
    11- Number of patients with Tuberculosis Symptom Profile symptoms at Week 36 and at the end of the treatment-free follow up
    12- Number of tuberculosis-related deaths per investigator assessment
    13- Number of patients with weight gain at Week 36 and at the end of the treatment-free follow up
    14- Number of patients with improvements in laboratory assessments at Week 36 and at the end of the treatment-free follow up
    15- Number of patients with improvements in chest radiograph assessments at Week 36 and at the end of the treatment-free follow up
    16 - Number of patients that received salvage regimen with favorable treatment outcome 24 weeks after the end of the individualized salvage regimen
    17 - Mean plasma concentrations of TMC207
    18- Mean plasma concentrations of N-monodesmethyl metabolite of TMC207
    19- Number of patients affected by an adverse event
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- Week 84
    2- Up to week 84
    3- Up to week 84
    4- Up to week 84
    5- Up to week 84
    6- Up to week 84
    7- Up to week 84
    8- Up to week 84
    9- Up to week 84
    10- Up to week 84
    11- Up to week 84
    12- Up to week 84
    13- Up to week 84
    14- Up to week 84
    15- Up to week 84
    16- Up to week 84
    17- Up to week 36
    18- Up to week 36
    19- Up to week 84
    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 Yes
    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
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number of treatment arms in the trial2
    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.8.5.1Number of sites anticipated in the EEA3
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Cambodia
    China
    Colombia
    Estonia
    Korea, Democratic People's Republic of
    Latvia
    Peru
    Philippines
    Russian Federation
    South Africa
    Taiwan
    Thailand
    Turkey
    Ukraine
    Vietnam
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 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: 594
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 13
    F.4.2.2In the whole clinical trial 600
    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 Decision2012-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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