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    EudraCT Number:2010-021125-12
    Sponsor's Protocol Code Number:TMC207TBC3001
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-01
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedLithuania - SMCA
    A.2EudraCT number2010-021125-12
    A.3Full title of the trial
    Early access of TMC207 in combination with other anti-tuberculosis (TB) drugs in subjects with extensively drug resistant (XDR) or pre-XDR pulmonary TB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TMC207TBC3001 - Early Access of TMC207 in Patients with Extensively Drug Resistant (XDR) or Pre-XDR Pulmonary Tuberculosis (TB)
    A.4.1Sponsor's protocol code numberTMC207TBC3001
    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.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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group - Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.4Telephone number+31 71 524 21 66
    B.5.5Fax number+31 71 524 21 10
    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 nameJNJ-16175328-AEP – Tablet – 120,89 mg (equiv. 100 mg free base)
    D.3.2Product code JNJ-16175328
    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 INNbedaquiline fumarate
    D.3.9.1CAS number 845533-86-0
    D.3.9.2Current sponsor codeTMC207
    D.3.9.3Other descriptive nameJNJ-16175328-AEP, R403323
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Tuberculosis (TB)
    E.1.1.1Medical condition in easily understood language
    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 provide early access to TMC207 for subjects who have pulmonary infection due to strains of M. tuberculosis with resistance to INH, RMP, and to a fluoroquinolone (FQ) and/or injectable 2nd line TB drug(kanamycin, amikacin, or capreomycin).
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety and tolerability of TMC207. In addition, the results of microbiology assessments which are recommended to be performed during the early access study will be described.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject with confirmed pulmonary XDR or pre-XDR-TB infection with resistance to INH, RMP, and to a FQ and/or injectable 2nd line TB drug (kanamycin, amikacin, or capreomycin). Confirmation should include previous (within the preceding 6 months) smear or culture and DST results demonstrating pulmonary TB with an XDR or pre-XDR resistance pattern.
    2. Subject has limited or no treatment options and is unable/ineligible to participate in any other TMC207 study.
    3. Aged ≥ 18 years.
    4. Subject will be managed at a medical center that has been certified by the Green Light Committee of the WHO Stop TB Partnership, OR, following an assessment of the site confirms that the site meets equivalent standards, including DOTS-Plus-equivalent supervision of medication administration; laboratory capacity to provide regular sputum cultures and drug susceptibility tests (DST); and an uninterrupted supply of approved second line drugs with which to create a companion BR.
    5. Medically stable in the opinion of the investigator on the basis of physical examination, and safety examinations performed at screening.
    6. All women of childbearing potential must have a negative urine pregnancy test at screening.
    7. Women must:
    – be postmenopausal for at least 2 years, or
    – be surgically sterile (have had a total hysterectomy or bilateral oophorectomy, tubal ligation/bilateral tubal clips without reversal operation, or otherwise be incapable of
    pregnancy), or
    – not be heterosexually active for the duration of the early access study, or
    – be practicing a highly effective method of birth control (as specified below), and agree to continue to use the same method of contraception throughout TB treatment:
    ◊ Use a double barrier method (i.e., male condom + either diaphragm or cervical cap),
    ◊ Use non-estrogen hormonal based contraceptives in combination with a barrier
    contraceptive (i.e., male condom, diaphragm or cervical cap, or femal condom), or
    ◊ Use an intrauterine device in combination with a barrier contraceptive (i.e., male condom, diaphragm or cervical cap, or female condom).
    Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
    8. Men must agree to use a highly effective method of birth control (i.e., male condom with either female intrauterine device, diaphragm, cervical cap or [non-estrogen] hormonal based contraceptives) and not to donate sperm during the early access study and for 3 months after receiving the last dose of TB treatment.
    Note: A male and female condom should not be used together due to risk of breakage or damage caused by latex friction.
    9. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the early access study.
    E.4Principal exclusion criteria
    1. History of and/or clinically relevant, currently active or underlying gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, respiratory (other than due to TB), inflammatory, neoplastic, skin, immunological or infectious disease, which is not stable and controlled.
    If there are clinically relevant, currently active or underlying diseases, they should not compromise the safety of the subject or the ability to participate in the study as judged by the investigator. The investigator is encouraged to discuss concomitant illnesses with the sponsor.
    2. Subjects with complicated or severe extra pulmonary manifestations of TB, including osteoarticular and central nervous system infection.
    3. HIV-infected subjects who cannot be treated with antiretroviral (ARVs) regimens as outlined in Section 4.4 during administration of TMC207.
    4. Having received TMC207 in a previous study.
    5. Subject is eligible for other Tibotec sponsored TMC207 studies.
    6. Known allergies, hypersensitivity, or intolerance to TMC207 or its excipients.
    7. Use of disallowed therapies as specified in the section of disallowed medication (see Section 8). 8. Are currently enrolled in another investigational study or have been enrolled in an
    investigational study within 60 days before the planned start of treatment with TMC207, unless approved by the sponsor.
    9. Pregnant or breast-feeding.
    10. Any condition that, in the opinion of the investigator, would compromise the early access study or the well-being of the subject or prevent the subject from meeting or performing protocol requirements.
    11. Current alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator’s opinion would compromise subject’s safety and/or compliance with the protocol procedures.
    12. Subjects with the following laboratory abnormalities at screening as defined by the DMID Adult Toxicity Table and in accordance with the normal ranges of the clinical laboratory at the site:
    - serum creatinine grade 1 or greater (> 1.0 x ULN);
    - lipase grade 2 (with no signs or symptoms of pancreatitis) or greater (> 1.5 x ULN);
    - AST or ALT grade 2 or greater (≥ 2.0 - < 3.0 x ULN);
    - total bilirubin grade 1 or greater (> 1.0 x ULN).
    Note: If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges (including the above listed parameters), the subject may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically relevant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the investigator.
    13. Subjects with QTcF interval > 450 msec at screening (and, if above the limit, confirmed by repeat single ECG).
    14. Subjects with any other clinically significant ECG abnormality at screening, such as arrhythmia, ischemia, or evidence of heart failure.
    15. Subjects with a family history of Long QT Syndrome.
    16. Vulnerable subjects (e.g., persons kept in detention).
    E.5 End points
    E.5.1Primary end point(s)
    This early access study will be conducted to make TMC207 available to subjects with extensively drug resistant (XDR) or pre-XDR TB infection who have limited-to-no treatment options. Data collection will be limited and no statistical hypotheses will be tested.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Early Access Program
    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. 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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    Russian Federation
    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 years3
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    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.1.1Number of subjects for this age range: 0
    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: 290
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 295
    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)
    The Early Access Program will guarantee access to TMC207 to subjects until marketing authorization and/or availability of the IMP in respective countries.
    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 Decision2011-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-01
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