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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44393   clinical trials with a EudraCT protocol, of which   7405   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:
    An open-label, multi-centre, randomised controlled trial evaluating the effects of short-course rifapentine-based regimens and additional adherence support on LTBI treatment adherence and completion among adults in the UK

    Summary
    EudraCT number
    		 2020-004444-29
    Trial protocol
    		 GB  
    Global end of trial date
    18 Dec 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Apr 2026
    First version publication date
    11 Apr 2026
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RID-TB:Treat
    Additional study identifiers
    ISRCTN number
    		 ISRCTN18128181
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University College London
    Sponsor organisation address
    90 High Holborn, London, United Kingdom, WC1V 6LJ
    Public contact
    Clinical Trials Manager, University College London, +44 2076704619, mrcctu.rid-tb@ucl.ac.uk
    Scientific contact
    Clinical Trials Manager, University College London, 7957778874 2076704619, mrcctu.rid-tb@ucl.ac.uk
    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
    18 Dec 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Dec 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Dec 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effect of a 28-dose daily and a 12-dose weekly rifapentine-based regimen compared to the standard 3 month daily rifampicin-based regimen on adherence of treatment for latent TB infection (LTBI). Adults aged 16-65 years eligible for TB preventive treatment were randomised 2:1:2:2 to: - 3 months of daily isoniazid plus rifampicin with routine adherence support (3HR, Arm 1) - 3HR with additional adherence support (3HR+AS, Arm 2) - weekly isoniazid plus rifapentine for 3 months with AS (3HP+AS, Arm 3) - daily isoniazid plus rifapentine for 4 weeks (1HP, Arm 4). Additional adherence support included electronic pill box reminders with supportive text messages.
    Protection of trial subjects
    The study engaged new entrants to the UK and contacts of people with active TB who subsequently received a positive LTBI test. This population is potentially marginalised, vulnerable or hard-to-engage in care. Engagement were carried out in such a way that stigma would be minimised, and participants were not disadvantaged in any way. Our PPI partner, TB Alert, has a long history working with the populations that we recruited from, and provided advice for our patient-facing interactions.
    Background therapy
    		 Pyridoxine
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Jun 2023
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 400
    Worldwide total number of subjects
    400
    EEA total number of subjects
    0
    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)
    399
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants recruited from 13 UK sites between 28 June 2023 and 30 June 2025.

    Pre-assignment
    Screening details
    		 LTBI diagnosis defined on the basis of all of the following: (a) a positive result on an Interferon Gamma Release Assay (IGRA), Tuberculin Skin Test (TST) or C-Tb skin test and (b) Active TB ruled out by attending clinicians Eligible for LTBI treatment at TB clinics and national LTBI screening services based on NICE guidelines

    Pre-assignment period milestones
    Number of subjects started
    		 400
    Number of subjects completed
    		 400

    Period 1
    Period 1 title
    Main Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1: 3HR
    Arm description
    		 Arm 1 - Standard of Care
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Rifampicin and Isoniazid
    Investigational medicinal product code
    3HR
    Other name
    Rifnah
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rifampicin and isoniazid (e.g. Rifinah® 150/100 mg or 300/150 mg. Sanofi Aventis. Fixed dose oral tablet) <50Kg 3 x Isoniazid/Rifampicin (e.g. fixed dose combination (150/100)) >= 50Kf 2 x Isoniazid / Rifampicin (e.g fixed dose combination (300/150)) Should be taken on an empty stomach (at least 30 minutes before food or 2 hours after food)

    Arm title
    		 Arm 2: 3HR + AS
    Arm description
    		 3HR + additional adherence support
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rifampicin and Isoniazid
    Investigational medicinal product code
    3HR
    Other name
    Rifnah
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rifampicin and isoniazid (e.g. Rifinah® 150/100 mg or 300/150 mg. Sanofi Aventis. Fixed dose oral tablet) <50Kg 3 x Isoniazid/Rifampicin (e.g. fixed dose combination (150/100)) >= 50Kf 2 x Isoniazid / Rifampicin (e.g fixed dose combination (300/150)) Should be taken on an empty stomach (at least 30 minutes before food or 2 hours after food)

    Arm title
    		 Arm 3: 3HP + AS
    Arm description
    		 3HP + additional adherence support
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rifapentine + Isonaiazid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rifapentine + Isoniazid once weekly for 12 doses (3 months) 30 to < 32Kg Rifapentine 600 mg _ Isoniazid 15mg / Kg 23 to < 50Kg Rifapentine 750 mg + Isoniazid 15 mg / kg >= 50 kg Rifapentine 900 mg + Isoniazid 15 mg / kg (900 mg maximum) Should be taken within one hour after a meal. The maximum recommended dose is 900 mg once weekly for 12 weeks and the maximum dose of isoniazid (15mg / Kg ) is 900 mg

    Arm title
    		 Arm 4: 1 HP
    Arm description
    		 1 HP
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rifapentine + isoniazid
    Investigational medicinal product code
    1HP
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Rifapentine plus isoniazid once daily for 28 doses (one month) 30 to <35 KG Rifapentine 300 mg + 300 mg isoniazid 35 to < 45 KG Rifapentine 450 mg + 300 mg isoniazid >= 45 KG Rifapentine 600 mg + 300 mg isoniazid Should be taken within one hour after a meal

    Number of subjects in period 1
    		Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1 HP
    Started
    116
    59
    113
    112
    Completed
    87
    45
    94
    89
    Not completed
    29
    14
    19
    23
         Other
    1
    1
    -
    3
         Participant refused to continue follow-up
    14
    3
    9
    8
         Lost to follow-up
    14
    8
    9
    11
         Late screening failure
    -
    2
    1
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: 3HR
    Reporting group description
    		 Arm 1 - Standard of Care

    Reporting group title
    Arm 2: 3HR + AS
    Reporting group description
    		 3HR + additional adherence support

    Reporting group title
    Arm 3: 3HP + AS
    Reporting group description
    		 3HP + additional adherence support

    Reporting group title
    Arm 4: 1 HP
    Reporting group description
    		 1 HP

    Reporting group values
    		 Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1 HP Total
    Number of subjects
    		 116 59 113 112 400
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 116 59 112 112 399
        From 65-84 years
    		 0 0 1 0 1
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 33 (28 to 39) 33 (28 to 36) 32 (27 to 38) 33 (27 to 41) -
    Gender categorical
    Units: Subjects
        Female
    		 58 27 59 48 192
        Male
    		 58 32 54 64 208
    TB Risk Group
    Units: Subjects
        High TB burden country
    		 58 29 56 55 198
        Close contact
    		 12 6 12 12 42
        Other
    		 46 24 45 45 160
    BCG vaccination status
    Units: Subjects
        Vaccinated
    		 77 47 82 78 284
        Unvaccinated
    		 13 4 11 10 38
        Unknown
    		 26 8 20 24 78
    Smoking status
    Units: Subjects
        Current smoker
    		 15 6 10 9 40
        Ex-smoker
    		 10 9 16 9 44
        Never smoked
    		 84 40 82 88 294
        Unknown
    		 7 4 5 5 21
        Prefer not to say
    		 0 0 0 1 1
    Weekly alcohol intake
    Units: Subjects
        No alcohol intake
    		 74 37 73 78 262
        0-4 units
    		 28 8 21 14 71
        5-9 units
    		 3 4 3 7 17
        10-14 units
    		 2 2 5 2 11
        15-20 units
    		 1 2 3 1 7
        Over 20 units
    		 0 0 0 1 1
        Unknown
    		 8 6 8 8 30
        Prefer not to say
    		 0 0 0 1 1

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Arm 1: 3HR
    Reporting group description
    		 Arm 1 - Standard of Care

    Reporting group title
    Arm 2: 3HR + AS
    Reporting group description
    		 3HR + additional adherence support

    Reporting group title
    Arm 3: 3HP + AS
    Reporting group description
    		 3HP + additional adherence support

    Reporting group title
    Arm 4: 1 HP
    Reporting group description
    		 1 HP

    Subject analysis set title
    Modified intention-to-treat
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The modified intention-to-treat (mITT) population excludes 5 participants, 1 who was randomised to Arm 1 but prescribed 1HP (Arm 4 IMP) in error and 4 who were late screening failures.

    Subject analysis set title
    Per protocol population
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Excludes 37 participants from the modified intention-to-treat population who did not have any drug intakes recorded by the Wisepill box.

    Subject analysis set title
    Safety population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Includes all randomised participants except for 19 participants who did not have study drug dispensed. One participant originally randomised to Arm 1 was prescribed 1HP in error and was analysed under Arm 4.

    Primary: Adequate treatment, defined as taking >=90 % of allocated doses

    		 Close Top of page
    End point title
    		 Adequate treatment, defined as taking >=90 % of allocated doses
    End point description
    In the primary analyses, adherence is measured using the Wisepill electronic pillboxes. The allowable time-frames for completing treatment are: For 3HP and 3HR- the original 12 weeks treatment period plus 4 weeks extension For 1HP- the original 4 weeks treatment period plus 2 weeks extension
    End point type
    Primary
    End point timeframe
    The allowable time-frame for achieving adequate treatment is considered from the date the study medication was first dispensed, and is defined according to the treatment regimen.
    End point values
    		 Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1 HP
    Number of subjects analysed
    100 [1]
    52 [2]
    108 [3]
    97 [4]
    Units: Subjects
    43
    25
    73
    53
    Notes
    [1] - 100 complete cases.
    [2] - 52 complete cases
    [3] - 108 complete cases
    [4] - 97 complete cases
    Statistical analysis title
    		 Co-primary analysis Arm 4 vs Arm 1 (mITT)
    Statistical analysis description
    The primary analyses included all of the mITT population, with imputation methods accounting for missing data. For EudrACT reporting of number of counts, this was based on complete cases only.
    Comparison groups
    Arm 1: 3HR v Arm 4: 1 HP
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.055 [5]
    Method
    		 Modified Poisson regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.73
    Notes
    [5] - Modified Poisson regression was used to estimate the risk ratio. BootMI procedure was used to account for missing Wisepill data. An ANOVA model was then fitted to the BxM point estimates to derive the standard error and p-value.
    Statistical analysis title
    		 Co-primary analysis Arm 3 vs Arm 1 (mITT)
    Statistical analysis description
    The primary analyses included all of the mITT population, with imputation methods accounting for missing data. For EudrACT reporting of number of counts, this was based on complete cases only.
    Comparison groups
    Arm 1: 3HR v Arm 3: 3HP + AS
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.001 [6]
    Method
    		 Modified Poisson regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 1.99
    Notes
    [6] - Modified Poisson regression was used to estimate the risk ratio. BootMI procedure was used to account for missing Wisepill data. An ANOVA model was then fitted to the BxM point estimates to derive the standard error and p-value.

    Secondary: Proportion (%) of allocated doses missed as measured using Wisepill box

    		 Close Top of page
    End point title
    		 Proportion (%) of allocated doses missed as measured using Wisepill box
    End point description
    End point type
    Secondary
    End point timeframe
    As defined for the primary outcome.
    End point values
    		 Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1 HP
    Number of subjects analysed
    115
    57
    112
    111
    Units: Proportion of allocated doses missed
        median (inter-quartile range (Q1-Q3))
    13.8 (1.1 to 51.8)
    9.9 (0.1 to 58.3)
    0.1 (0.0 to 37.7)
    3.1 (0.0 to 27.6)
    Statistical analysis title
    		 Comparing Arm 3 vs Arm 1
    Statistical analysis description
    Based on mITT population, with imputing methods accounting for missing Wisepill data. The absolute difference in the median proportion of doses missed between the arms was estimated.
    Comparison groups
    Arm 1: 3HR v Arm 3: 3HP + AS
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [7]
    Method
    		 Quantile regression
    Parameter type
    		 Median difference (final values)
    Point estimate
    -13.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -22.1
         upper limit
    		 -5.5
    Notes
    [7] - BootMI procedure used to account for missing data and estimate the standard error and corresponding p-value.
    Statistical analysis title
    		 Comparing Arm 4 vs Arm 1
    Comparison groups
    Arm 1: 3HR v Arm 4: 1 HP
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.046 [8]
    Method
    		 Quantile regression
    Parameter type
    		 Median difference (final values)
    Point estimate
    -10.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -21.2
         upper limit
    		 -0.2
    Notes
    [8] - BootMI procedure used to account for missing data and estimate the standard error and corresponding p-value.

    Secondary: Taking at least 90% of doses over treatment period, measured using pill counts

    		 Close Top of page
    End point title
    		 Taking at least 90% of doses over treatment period, measured using pill counts
    End point description
    End point type
    Secondary
    End point timeframe
    Same as that defined for the primary outcome.
    End point values
    		 Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1 HP
    Number of subjects analysed
    84 [9]
    41 [10]
    88 [11]
    80 [12]
    Units: subjects
    75
    39
    77
    72
    Notes
    [9] - 115 in modified intention to treat population 31 participants with missing pill count data
    [10] - 57 in modified intention to treat population 16 participants with missing pill count data
    [11] - 112 in modified intention to treat population 24 participants with missing pill count data
    [12] - 111 in modified intention to treat population 31 participants with missing pill count data
    Statistical analysis title
    		 Comparing Arm 4 vs Arm 1
    Statistical analysis description
    The original analysis included the overall mITT population accounting for missing data. For EudrACT reporting of number of participants achieving the endpoint, this was based on complete case analysis.
    Comparison groups
    Arm 1: 3HR v Arm 4: 1 HP
    Number of subjects included in analysis
    164
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.102
    Method
    		 Modified Poisson regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.22
    Statistical analysis title
    		 Comparing Arm 3 vs Arm 1
    Statistical analysis description
    The original analysis included the overall mITT population accounting for missing data. For EudrACT reporting of number of participants achieving the endpoint, this was based on complete case analysis.
    Comparison groups
    Arm 1: 3HR v Arm 3: 3HP + AS
    Number of subjects included in analysis
    172
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.989
    Method
    		 Modified Poisson regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.14

    Secondary: Permanently stopping study treatment due to drug-related adverse event

    		 Close Top of page
    End point title
    		 Permanently stopping study treatment due to drug-related adverse event
    End point description
    End point type
    Secondary
    End point timeframe
    As defined for the primary outcome.
    End point values
    		 Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1 HP Safety population
    Number of subjects analysed
    111
    56
    106
    108
    381
    Units: subjects
    4
    2
    1
    4
    11
    Statistical analysis title
    		 Comparing Arm 3 vs Arm 1
    Statistical analysis description
    Based on safety population.
    Comparison groups
    Arm 1: 3HR v Arm 3: 3HP + AS
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.37
    Method
    		 Fisher exact
    Parameter type
    		 Not estimated due to sparse data
    Confidence interval
    Statistical analysis title
    		 Comparing Arm 4 vs Arm 1
    Statistical analysis description
    Based on safety population.
    Comparison groups
    Arm 1: 3HR v Arm 3: 3HP + AS
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 1
    Method
    		 Fisher exact
    Parameter type
    		 No presented due to sparse data
    Confidence interval

    Secondary: Early study treatment discontinuation for any reason

    		 Close Top of page
    End point title
    		 Early study treatment discontinuation for any reason
    End point description
    Early discontinuation of treatment as reported by site staff.
    End point type
    Secondary
    End point timeframe
    Same as that for the primary outcome.
    End point values
    		 Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1 HP
    Number of subjects analysed
    115
    57
    112
    111
    Units: subjects
    20
    7
    17
    15
    Statistical analysis title
    		 Comparing Arm 3 vs Arm 1
    Statistical analysis description
    Based on mITT population.
    Comparison groups
    Arm 1: 3HR v Arm 3: 3HP + AS
    Number of subjects included in analysis
    227
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.646
    Method
    		 Modified Poisson regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.58
    Statistical analysis title
    		 Comparing Arm 4 vs Arm 1
    Statistical analysis description
    Based on mITT population.
    Comparison groups
    Arm 1: 3HR v Arm 4: 1 HP
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.41
    Method
    		 Modified Poisson regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.43

    Secondary: Grade >= 3 adverse events up to 20 weeks

    		 Close Top of page
    End point title
    		 Grade >= 3 adverse events up to 20 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 20 weeks from randomisation date
    End point values
    		 Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1 HP
    Number of subjects analysed
    111
    56
    106
    108
    Units: subjects
    1
    0
    3
    3
    Statistical analysis title
    		 Comparing Arm 4 vs Arm 1
    Statistical analysis description
    Based on safety population.
    Comparison groups
    Arm 1: 3HR v Arm 4: 1 HP
    Number of subjects included in analysis
    219
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.353
    Method
    		 Fisher exact
    Confidence interval
    Statistical analysis title
    		 Comparing Arm 3 vs Arm 1
    Statistical analysis description
    Based on safety population.
    Comparison groups
    Arm 3: 3HP + AS v Arm 1: 3HR
    Number of subjects included in analysis
    217
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.618
    Method
    		 Fisher exact
    Confidence interval

    Secondary: Development of active TB

    		 Close Top of page
    End point title
    		 Development of active TB
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 12 months from randomisation.
    End point values
    		 Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1 HP
    Number of subjects analysed
    111
    56
    106
    108
    Units: subjects
    1
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From date medication first dispensed up to 20 weeks from date of randomisation.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Arm 1: 3HR
    Reporting group description
    		 3HR

    Reporting group title
    Arm 2: 3HR + AS
    Reporting group description
    		 3HR + Additonal Adherence Support

    Reporting group title
    Arm 3: 3HP + AS
    Reporting group description
    		 3HP + Additonal Adherence Support

    Reporting group title
    Arm 4: 1HP
    Reporting group description
    		 1HP

    Serious adverse events
    		 Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1HP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    2 / 106 (1.89%)
    0 / 108 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Reproductive system and breast disorders
    Ovarian abscess
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm 1: 3HR Arm 2: 3HR + AS Arm 3: 3HP + AS Arm 4: 1HP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 111 (46.85%)
    24 / 56 (42.86%)
    53 / 106 (50.00%)
    50 / 108 (46.30%)
    General disorders and administration site conditions
    Hunger
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    1
    1
    Flank pain
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    2 / 111 (1.80%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    2
    1
    0
    1
    Asthenia
         subjects affected / exposed
    2 / 111 (1.80%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    3
    1
    0
    2
    Chest discomfort
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Malaise
         subjects affected / exposed
    3 / 111 (2.70%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Pain
         subjects affected / exposed
    0 / 111 (0.00%)
    2 / 56 (3.57%)
    2 / 106 (1.89%)
    0 / 108 (0.00%)
         occurrences all number
    0
    4
    2
    0
    Night sweats
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    8 / 111 (7.21%)
    1 / 56 (1.79%)
    11 / 106 (10.38%)
    3 / 108 (2.78%)
         occurrences all number
    8
    1
    11
    3
    Decreased appetite
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    4 / 106 (3.77%)
    2 / 108 (1.85%)
         occurrences all number
    1
    0
    4
    2
    Pyrexia
         subjects affected / exposed
    3 / 111 (2.70%)
    2 / 56 (3.57%)
    5 / 106 (4.72%)
    3 / 108 (2.78%)
         occurrences all number
    3
    2
    5
    3
    Immune system disorders
    Psoriasis
         subjects affected / exposed
    2 / 111 (1.80%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    2
    Reproductive system and breast disorders
    Ovarian abscess
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    0
    0
    Menstruation delayed
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    0 / 111 (0.00%)
    2 / 56 (3.57%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    2
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    2 / 106 (1.89%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Productive cough
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    3 / 108 (2.78%)
         occurrences all number
    0
    0
    0
    3
    Chest pain
         subjects affected / exposed
    0 / 111 (0.00%)
    2 / 56 (3.57%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Cough
         subjects affected / exposed
    1 / 111 (0.90%)
    4 / 56 (7.14%)
    2 / 106 (1.89%)
    1 / 108 (0.93%)
         occurrences all number
    1
    4
    2
    1
    Pleuritic pain
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Seasonal allergy
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Wheezing
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Sinus pain
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 111 (0.90%)
    1 / 56 (1.79%)
    3 / 106 (2.83%)
    2 / 108 (1.85%)
         occurrences all number
    1
    1
    3
    3
    Agitation
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Depression
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Anxiety
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Product issues
    Device colour issue
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    C-reactive protein increased
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Chest X-ray abnormal
         subjects affected / exposed
    2 / 111 (1.80%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Liver function test increased
         subjects affected / exposed
    6 / 111 (5.41%)
    1 / 56 (1.79%)
    1 / 106 (0.94%)
    11 / 108 (10.19%)
         occurrences all number
    9
    1
    1
    15
    Neutrophil count decreased
         subjects affected / exposed
    2 / 111 (1.80%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    White blood cell count decreased
         subjects affected / exposed
    2 / 111 (1.80%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Injury, poisoning and procedural complications
    Accident at work
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Palpitations
         subjects affected / exposed
    2 / 111 (1.80%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 111 (8.11%)
    4 / 56 (7.14%)
    12 / 106 (11.32%)
    16 / 108 (14.81%)
         occurrences all number
    10
    5
    13
    17
    Bradykinesia
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Burning feet syndrome
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dizziness
         subjects affected / exposed
    4 / 111 (3.60%)
    0 / 56 (0.00%)
    3 / 106 (2.83%)
    5 / 108 (4.63%)
         occurrences all number
    4
    0
    3
    5
    Memory impairment
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Migraine
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    3 / 108 (2.78%)
         occurrences all number
    0
    0
    1
    3
    Tinnitus
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Vision blurred
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Bradyphrenia
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Neuropathy peripheral
         subjects affected / exposed
    7 / 111 (6.31%)
    4 / 56 (7.14%)
    7 / 106 (6.60%)
    3 / 108 (2.78%)
         occurrences all number
    7
    4
    7
    3
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Scleral discolouration
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Dyspepsia
         subjects affected / exposed
    1 / 111 (0.90%)
    1 / 56 (1.79%)
    1 / 106 (0.94%)
    5 / 108 (4.63%)
         occurrences all number
    1
    1
    1
    5
    Faeces discoloured
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain lower
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 56 (1.79%)
    1 / 106 (0.94%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    1
    1
    Abdominal pain
         subjects affected / exposed
    3 / 111 (2.70%)
    1 / 56 (1.79%)
    2 / 106 (1.89%)
    3 / 108 (2.78%)
         occurrences all number
    4
    1
    2
    3
    Diarrhoea
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    2 / 106 (1.89%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Constipation
         subjects affected / exposed
    3 / 111 (2.70%)
    1 / 56 (1.79%)
    1 / 106 (0.94%)
    3 / 108 (2.78%)
         occurrences all number
    3
    1
    1
    3
    Tongue dry
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    10 / 111 (9.01%)
    4 / 56 (7.14%)
    14 / 106 (13.21%)
    14 / 108 (12.96%)
         occurrences all number
    11
    4
    20
    14
    Haematochezia
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Dysgeusia
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vomiting
         subjects affected / exposed
    2 / 111 (1.80%)
    0 / 56 (0.00%)
    6 / 106 (5.66%)
    4 / 108 (3.70%)
         occurrences all number
    2
    0
    6
    4
    Tooth fracture
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    2 / 108 (1.85%)
         occurrences all number
    1
    0
    0
    2
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Alopecia
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Pruritus
         subjects affected / exposed
    5 / 111 (4.50%)
    2 / 56 (3.57%)
    3 / 106 (2.83%)
    3 / 108 (2.78%)
         occurrences all number
    5
    2
    7
    3
    Lip oedema
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Swelling face
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash pruritic
         subjects affected / exposed
    2 / 111 (1.80%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Acne
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pruritus genital
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    1
    0
    0
    1
    Rash
         subjects affected / exposed
    4 / 111 (3.60%)
    3 / 56 (5.36%)
    4 / 106 (3.77%)
    7 / 108 (6.48%)
         occurrences all number
    4
    3
    4
    7
    Renal and urinary disorders
    Bladder irritation
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dysuria
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    2 / 106 (1.89%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Chromaturia
         subjects affected / exposed
    14 / 111 (12.61%)
    6 / 56 (10.71%)
    13 / 106 (12.26%)
    14 / 108 (12.96%)
         occurrences all number
    14
    6
    49
    16
    Proteinuria
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    2 / 106 (1.89%)
    1 / 108 (0.93%)
         occurrences all number
    1
    0
    2
    1
    Muscular weakness
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arthralgia
         subjects affected / exposed
    2 / 111 (1.80%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    3 / 108 (2.78%)
         occurrences all number
    2
    0
    1
    3
    Arthritis
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neck pain
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neuromuscular pain
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    2 / 106 (1.89%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Enterobiasis
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anal abscess
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 111 (1.80%)
    1 / 56 (1.79%)
    5 / 106 (4.72%)
    0 / 108 (0.00%)
         occurrences all number
    3
    1
    5
    0
    Eye infection
         subjects affected / exposed
    1 / 111 (0.90%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    0 / 108 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Genital candidiasis
         subjects affected / exposed
    0 / 111 (0.00%)
    1 / 56 (1.79%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    1
    0
    1
    Influenza
         subjects affected / exposed
    2 / 111 (1.80%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    2 / 108 (1.85%)
         occurrences all number
    2
    0
    1
    2
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    1 / 106 (0.94%)
    0 / 108 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vitamin D deficiency
         subjects affected / exposed
    0 / 111 (0.00%)
    0 / 56 (0.00%)
    0 / 106 (0.00%)
    1 / 108 (0.93%)
         occurrences all number
    0
    0
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Mar 2021
    Clarified exclusion criteria, included maximum recommended dosing, and clarified procedures for assessing safety.
    25 Apr 2022
    Removal of arm 6 (i.e. 1HP additional adherence support arm), clarification of an inclusion criteria point. Study sample size, randomisation allocation ratio, estimands, analysis plan updated. Addition of a new questionnaire and fidelity checklist.
    30 Jul 2022
    Updates to the assessment table, visit window periods, and Patient Information Sheet (v3.0) to reflect the study design change previously submitted. Addition of a health economics questionnaire. Rifapentine labels and Isoniazid SmPC submitted.
    10 Oct 2022
    Remove the 3HP with routine adherence support arm, lower the sample size, adjust the randomisation ratio, adjusting the adherence intervention, simplifing the inclusion and exclusion criteria, and update study hypotheses, primary and secondary objectives. Include single dose regimens with active substance, Rifampicin and Isoniazid, and leave Rifinah as the fixed dose regimen example. Update to the Patient Information Sheet (v4.0) to reflect the study design change.
    08 Apr 2024
    Standard of care arms (rifampicin plus isoniazid) can be taken for 84 doses (3 month long cycles of 28 doses) as per standard of care local practice, as well as 90 doses (3 months) as originally stated in the protocol. Update to primary outcome treatment completion timeframe. Clarification of tests needing repeating should they be too old at treatment start.
    03 Apr 2025
    Removal of a secondary outcome and rephrasing of a secondary outcome. Addition of optional questionnaire for migrant sensitivity analysis.

    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.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 18 05:08:56 CEST 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA