Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   40665   clinical trials with a EudraCT protocol, of which   6637   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Early Access of TMC207 in Combination With Other Anti-tuberculosis (TB) Drugs in Subjects With Extensively Drug Resistant (XDR) or Pre-XDR Pulmonary TB

    Summary
    EudraCT number
    2010-021125-12
    Trial protocol
    LT  
    Global end of trial date
    01 Dec 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    15 Dec 2017
    First version publication date
    15 Dec 2017
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    TMC207TBC3001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01464762
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Infectious Diseases BVBA
    Sponsor organisation address
    Turnhoutseweg 30, Beerse, Belgium, 2340
    Public contact
    Clinical Registry Group, Janssen Infectious Diseases BVBA, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Infectious Diseases BVBA, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Dec 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective was to provide early access to bedaquiline for subjects who had pulmonary infection due to strains of Mycobacterium tuberculosis (M. tuberculosis) with resistance to Isoniazid (INH), Rifampicin/Rifampin (RMP), and to a Fluoroquinolone (FQ) and/or injectable second-line Tuberculosis (TB) drug (Kanamycin [KAN], Amikacin [AMK], or Capreomycin [CAP]).
    Protection of trial subjects
    The safety assessments included monitoring of adverse events (AEs), changes in clinical laboratory test values (hematology, serum chemistry and urinalysis), vital sign measurements, physical examination results, chest X-ray, microbiological status, specific toxicities and electrocardiogram (ECG) from the screening phase through study completion at defined timepoints.
    Background therapy
    The selection of the background (BR) was the responsibility of the investigator and had to be constructed with at least 3 anti-TB drugs to which the subject’s TB isolate was known to be susceptible from recent drug susceptibility testing (DST) results (within the previous 6 months) or likely to be susceptible based on known treatment history.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    11 Jan 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    2 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Lithuania: 3
    Country: Number of subjects enrolled
    Russian Federation: 54
    Worldwide total number of subjects
    57
    EEA total number of subjects
    3
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    57
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    The study was conducted from 11 January 2012 to 1 December 2016 at 04 sites in 2 countries.

    Pre-assignment
    Screening details
    A total 61 subjects were screened, of whom 57 were enrolled and treated. 43 subjects completed the study and 14 subjects discontinued the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Arm title
    Bedaquiline/BR
    Arm description
    Subjects received bedaquiline 400 milligram (mg) as (4*100 mg) oral tablet once daily for 2 weeks followed by 200 mg as (2*100 mg) oral tablet three times per week for 22 weeks, along with background regimen (BR) drugs (Investigational treatment phase). After the last intake of bedaquiline, all subjects continued to take their BR, under the supervision of their treating physician or local health center/hospital in accordance with national tuberculosis program (NTP) guidelines and local multidrug resistant tuberculosis including Pre-extensively drug resistant tuberculosis (pre-XDR) and XDR (MDR-TB) treatment practice up to weeks 96 (BR only phase).
    Arm type
    Experimental

    Investigational medicinal product name
    Bedaquiline
    Investigational medicinal product code
    TMC207
    Other name
    JNJ-16175328-AEP, R403323
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received bedaquiline 400 mg as (4*100 mg) oral tablet once daily for 2 weeks followed by 200 mg as (2*100 mg) oral tablet three times per week for 22 weeks.

    Number of subjects in period 1
    Bedaquiline/BR
    Started
    57
    Completed
    43
    Not completed
    14
         Other
    5
         Adverse event, serious fatal
    3
         Adverse event, non-fatal
    2
         Consent withdrawn by subject
    2
         Lost to follow-up
    2

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Bedaquiline/BR
    Reporting group description
    Subjects received bedaquiline 400 milligram (mg) as (4*100 mg) oral tablet once daily for 2 weeks followed by 200 mg as (2*100 mg) oral tablet three times per week for 22 weeks, along with background regimen (BR) drugs (Investigational treatment phase). After the last intake of bedaquiline, all subjects continued to take their BR, under the supervision of their treating physician or local health center/hospital in accordance with national tuberculosis program (NTP) guidelines and local multidrug resistant tuberculosis including Pre-extensively drug resistant tuberculosis (pre-XDR) and XDR (MDR-TB) treatment practice up to weeks 96 (BR only phase).

    Reporting group values
    Bedaquiline/BR Total
    Number of subjects
    57 57
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    57 57
        From 65 to 84 years
    0 0
        85 years and over
    0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    31.2 ± 10.87 -
    Title for Gender
    Units: subjects
        Female
    33 33
        Male
    24 24

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Bedaquiline/BR
    Reporting group description
    Subjects received bedaquiline 400 milligram (mg) as (4*100 mg) oral tablet once daily for 2 weeks followed by 200 mg as (2*100 mg) oral tablet three times per week for 22 weeks, along with background regimen (BR) drugs (Investigational treatment phase). After the last intake of bedaquiline, all subjects continued to take their BR, under the supervision of their treating physician or local health center/hospital in accordance with national tuberculosis program (NTP) guidelines and local multidrug resistant tuberculosis including Pre-extensively drug resistant tuberculosis (pre-XDR) and XDR (MDR-TB) treatment practice up to weeks 96 (BR only phase).

    Subject analysis set title
    Bedaquiline (Overall Treatment Phase)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Subjects received bedaquiline 400 milligram (mg) orally once daily for 2 weeks followed by 200 mg orally three times weekly for 22 weeks, along with background regimen drugs. After 22 weeks subjects were continued to take their background regimen for 96 weeks.

    Primary: Number of Subjects with Adverse Event

    Close Top of page
    End point title
    Number of Subjects with Adverse Event [1]
    End point description
    An adverse event is any untoward medical event that occurs in a subject administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Safety data were analyzed based on the Intent- to- Treat (ITT) population, which included all subjects who had at least one intake of bedaquiline, regardless of their compliance with the protocol.
    End point type
    Primary
    End point timeframe
    Screening up to weeks 120
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics was performed and no inferential statistical analyses was performed for this endpoint.
    End point values
    Bedaquiline (Overall Treatment Phase)
    Number of subjects analysed
    57
    Units: subjects
    50
    No statistical analyses for this end point

    Secondary: Number of Subjects with Mycobacterial Status Over Time

    Close Top of page
    End point title
    Number of Subjects with Mycobacterial Status Over Time
    End point description
    Mycobacterial growth culture was measured locally as per local standard of care (smear, culture, drug susceptibility testing {DST}). Subjects overall result was classified as: Positive, if at least one result was positive from qualitative results available for both media; Negative, if both results were negative or if one result was negative and the other unknown. Intent-to-treat (ITT) population includes all subjects who had at least one intake of bedaquiline, regardless of their compliance with the protocol.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24, 48, 72, 96 and 120
    End point values
    Bedaquiline (Overall Treatment Phase)
    Number of subjects analysed
    57
    Units: Subjects
        Baseline, Positive
    52
        Baseline, Negative
    4
        Week 24, Positive
    5
        Week 24, Negative
    35
        Week 48, Positive
    4
        Week 48, Negative
    27
        Week 72, Positive
    3
        Week 72, Negative
    19
        Week 96, Positive
    1
        Week 96, Negative
    5
        Week 120, Positive
    0
        Week 120, Negative
    7
    No statistical analyses for this end point

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Screening up to 120 weeks
    Adverse event reporting additional description
    A third subject died during the Follow up phase after the overall treatment phase.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Bedaquiline (Overall treatment phase)
    Reporting group description
    Subjects received bedaquiline 400 milligram (mg) orally once daily for 2 weeks followed by 200 mg orally three times weekly for 22 weeks, along with background regimen drugs. After 22 weeks subjects were to continue to take their background regimen for 120 weeks.

    Serious adverse events
    Bedaquiline (Overall treatment phase)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 57 (14.04%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cervix Carcinoma Stage 0
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Haemorrhage
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 2
    Psychiatric disorders
    Psychotic Disorder
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Bedaquiline (Overall treatment phase)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 57 (87.72%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Hypotension
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    General disorders and administration site conditions
    Facial Pain
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Asthenia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    4
    Abnormal Behaviour
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    4
    Depressive Symptom
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Insomnia
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Reproductive system and breast disorders
    Pelvic Fluid Collection
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Ovarian Cyst
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Prostatitis
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Investigations
    Bilirubin Conjugated Increased
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Alanine Aminotransferase Increased
         subjects affected / exposed
    15 / 57 (26.32%)
         occurrences all number
    27
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    28 / 57 (49.12%)
         occurrences all number
    44
    Blood Bilirubin Increased
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    3
    Blood Amylase Increased
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Blood Pressure Increased
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Blood Creatinine Increased
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    5
    Blood Urea Increased
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Blood Thyroid Stimulating Hormone Increased
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    4
    Electrocardiogram Repolarisation Abnormality
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Electrocardiogram QT Prolonged
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Blood Uric Acid Increased
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Arrhythmia Supraventricular
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Atrioventricular Block
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Atrioventricular Block First Degree
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Bundle Branch Block Left
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Sinoatrial Block
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Cardiomyopathy
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Sinus Bradycardia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Ventricular Extrasystoles
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Asphyxia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Cough
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    8
    Bronchitis Chronic
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Dyspnoea
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    4
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Eosinophilia
         subjects affected / exposed
    13 / 57 (22.81%)
         occurrences all number
    16
    Nervous system disorders
    Complex Regional Pain Syndrome
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Exertional Headache
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Encephalopathy
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    3
    Neuropathy Peripheral
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Hypoaesthesia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Hemianopia Heteronymous
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Peripheral Sensory Neuropathy
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Polyneuropathy
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Eye disorders
    Retinopathy Hypertensive
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Amblyopia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Vitreous Opacities
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Hearing Impaired
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Tinnitus
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Conductive Deafness
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Abdominal Pain Upper
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Disbacteriosis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    4
    Gastritis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    2
    Gastritis Atrophic
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Gastroduodenitis
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    3
    Nausea
         subjects affected / exposed
    8 / 57 (14.04%)
         occurrences all number
    11
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Hiatus Hernia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Odynophagia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Pancreatitis Acute
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Renal and urinary disorders
    Cystitis Noninfective
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    2
    Haematuria
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    3
    Nephropathy Toxic
         subjects affected / exposed
    7 / 57 (12.28%)
         occurrences all number
    16
    Leukocyturia
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    4
    Proteinuria
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    6
    Hepatobiliary disorders
    Hepatotoxicity
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    5
    Hyperbilirubinaemia
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Dermatitis
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    3
    Dermatitis Allergic
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Dermatitis Contact
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Dry Skin
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Hyperkeratosis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    6
    Fibromyalgia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Neck Pain
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Muscle Twitching
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Osteoporosis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Osteochondrosis
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Tendonitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    4
    Primary Hypothyroidism
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Hypernatraemia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Hyperuricaemia
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Hypokalaemia
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    8
    Hypomagnesaemia
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Ear Infection
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Hepatitis C
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Cervicitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Herpes Simplex
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Oesophageal Candidiasis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Papilloma Viral Infection
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Oral Herpes
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Rash Pustular
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Respiratory Tract Infection
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    2
    Respiratory Tract Infection Viral
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Vaginal Infection
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1
    Vaginitis Bacterial
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences all number
    2
    Vulvovaginal Candidiasis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences all number
    1

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    07 May 2012
    Based on new safety information regarding an effect on QT interval corrected for heart rate according to Fridericia (QTcF) during concomitant use of clofazimine and bedaquiline in study TMC207-TiDP13-C209, and based on feedback from the Food and Drug Administration (FDA) relative to the special protocol assessment for study TMC207-TiDP13-C210, the sponsor decided to add visits (Week 1, 3, 4, 6, and 8) for subjects who were taking clofazimine with bedaquiline to enable additional electrocardiogram (ECG) monitoring (on mandatory planned visits: Day 1, Week 2, 12 and 24, these subjects also require ECG monitoring). Directly observed treatment short course (DOT) verification had to take place at all additional visits.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    No control arm was included in this study and only subjects with Pre-extensively drug resistant (pre-XDR) or XDR tuberculosis (TB) were allowed to participate. Enrollment was predominantly in Russia.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA