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    Summary
    EudraCT Number:2008-008444-25
    Sponsor's Protocol Code Number:TMC207-TiDP13-C209
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-29
    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 number2008-008444-25
    A.3Full title of the trial
    A Phase II, open-label trial with TMC207 as part of a multi-drug resistant tuberculosis (MDR-TB) treatment regimen in subjects with sputum smear-positive pulmonary infection with MDR-TB.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, tolerability and effectiveness of TMC207 in combination with an individualized background regimen in MDR-TB (Multi-drug Resistant Tuberculosis).

    A.4.1Sponsor's protocol code numberTMC207-TiDP13-C209
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sputum smear-positive pulmonary 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
    − To evaluate safety, tolerability, and efficacy of TMC207 as part of a multi-drug regimen in the treatment of subjects with MDR-TB;
    − To evaluate the pharmacokinetics of TMC207 and its primary metabolite M2, and pharmacokinetic/pharmacodynamic relationships for safety and efficacy.
    − To explore the effect of TMC207 on the experience of TB symptoms as measured by the Tuberculosis Symptoms Profile (TSP), and to explore the measurement properties of the TSP.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects aged 18 years or older. Females may participate if they are of nonchildbearing potential, if they are using effective birth control methods and are willing to continue practicing birth control methods as outlined in Protocol Section 5.2.4 throughout MDR-TB treatment, or if they are nonheterosexually active or willing to practice sexual abstinence throughout MDR-TB treatment.
    2. Confirmed pulmonary MDR-TB infection, which is defined as infection by a strain of M. tuberculosis resistant to at least both RMP and INH by previous screening from a TB treatment facility or by use of a rapid screen test within the preceding 6 months. Subjects infected with XDR-TB are also allowed to enter the trial if they have at least 3 TB drugs in their BR to which they are likely to be susceptible.
    3. Positive for acid-fast bacilli (AFB) on direct smear examination of expectorated sputum specimen (≥ 1+ smear-positive) or sputum culture positive for Mycobacterium tuberculosis within the preceding 6 months.
    4. Documented HIV-negative or -positive status at screening or within 1 month prior to trial start (via enzyme-linked immunosorbent assay [ELISA] and/or Western Blot). Note: HIV-positive subjects are eligible, provided they meet the requirements and are willing to follow the ARV treatment procedures as outlined in Section 5.2.4 and they are not using disallowed (ARV) medication as described in Section 5.3.11.
    5. Subjects having signed the ICF voluntarily before the first trial-related activity.
    6. Subjects who can comply with protocol requirements.
    7. Subjects who agree to comply with the NTP treatment guidelines.
    E.4Principal exclusion criteria
    1. Subjects having a known or suspected hypersensitivity or serious adverse reaction to TMC207.
    2. Subjects using disallowed concomitant therapy as specified in Protocol Section 5.3.11.
    3. Subjects having a current or past history of alcohol and/or drug use that, in the investigator's opinion, would compromise the subject's safety or compliance to the study protocol procedures.
    4. HIV infected subjects having a CD4+ count < 250 cells/μL.
    5. Subjects with significant cardiac arrhythmia requiring medication.
    6. Subjects with complicated or severe extrapulmonary manifestations of TB, including central nervous system infection.
    7. Having participated in other clinical studies with investigational agents, within 8 weeks prior to trial start.
    8. Presence of any concomitant severe illness or rapidly deteriorating health condition, including immune deficiency that would make implementation of the protocol or interpretation of the study results difficult or otherwise make the subject a poor candidate for a clinical trial.
    9. Subjects with the following QT/QTc interval characteristics at screening:
    a. A marked prolongation of QT/QTc interval, e.g., confirmed demonstration of QTcF (Fridericia correction) interval > 450 ms at screening;
    b. A history of additional risk factors for Torsade de Pointes, e.g., heart failure, hypokalemia, family history of Long QT Syndrome;
    c. The use of concomitant medications that prolong the QT/QTc interval listed as disallowed medication in Protocol Section 5.3.11;
    d. Pathological Q-waves (defined as > 40 ms or depth > 0.4-0.5 mV);
    e. Evidence of ventricular pre-excitation;
    f. ECG evidence of complete or incomplete left bundle branch block or right bundle branch block;
    g. Evidence of second or third degree heart block;
    h. Intraventricular conduction delay with QRS duration > 120 ms;
    i. Bradycardia as defined by sinus rate < 50 bpm.
    10. Subjects with the following toxicities at screening as defined by the enhanced Division of Microbiology and Infectious Diseases (DMID) adult toxicity table (November 2007):
    - Creatinine grade 2 or greater (> 1.5 times upper limit of normal [ULN]);
    - Lipase grade 3 or greater (> 2.0 x ULN);
    - Hemoglobin grade 4 (< 6.5 g/dL) except after discussion with the Medical Leader;
    - Aspartate aminotransferase (AST) grade 4 (> 8.0 x ULN) to be excluded, grade 3 (≥ 3.0 x ULN) must be discussed with Medical Leader;
    - Alanine aminotransferase (ALT) grade 4 (> 8.0 x ULN) to be excluded, grade 3 (≥ 3.0 x ULN) must be discussed with Medical Leader;
    - Alkaline phosphatase (ALP) grade 4 (> 8.0 x ULN) to be excluded, grade 3 (≥ 3.0 x ULN) must be discussed with Medical Leader;
    - Total bilirubin grade 3 or greater (> 2.00 x ULN, or > 1.50 x ULN when accompanied by any increase in other liver function test) to be excluded, grade 2 (> 1.50 x ULN, or > 1.25 x ULN when accompanied by any increase in other liver function test) must be discussed with the Medical Leader;
    11. Women who are pregnant or breastfeeding.
    12. Subjects who have previously received treatment with TMC207 as part of a clinical trial.
    13. Subjects having AIDS defining illnesses other than TB, or showing severe symptoms of HIV infection that would make the subject a poor candidate for participation in the trial.
    14. Subjects who, upon the evaluation of their pulmonary disease, will require surgical procedure for management of their TB infection within the 24-week treatment period with TMC207.
    E.5 End points
    E.5.1Primary end point(s)
    The median time to sputum conversion will be assessed using a Cox regression model.
    E.5.1.1Timepoint(s) of evaluation of this end point
    N/A
    E.5.2Secondary end point(s)
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned2
    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
    Argentina
    Brazil
    China
    Estonia
    Hong Kong
    India
    Korea, Democratic People's Republic of
    Latvia
    Mexico
    Peru
    Philippines
    Russian Federation
    South Africa
    Thailand
    Turkey
    Ukraine
    Vietnam
    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
    Last visit of the last subject
    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 months4
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days14
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 225
    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)
    Patient will be treated as per national standard of care.
    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 Decision2009-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-24
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