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    Clinical Trial Results:
    An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone When Administered to Patients With Systemic Sclerosis−Related Interstitial Lung Disease

    Summary
    EudraCT number
    		 2013-001353-28
    Trial protocol
    		 IT  
    Global end of trial date
    16 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2016
    First version publication date
    22 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PSSc-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01933334
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.com
    Scientific contact
    Roche Trial Information Hotline, F. Hoffmann-La Roche AG, +41 61 6878333, global.trial_information@roche.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
    09 Oct 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Sep 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This was a Phase 2, multinational, open-label, randomized, parallel-group study to evaluate safety and tolerability of pirfenidone in participants with systemic sclerosis−related interstitial lung disease (SSc-ILD).
    Protection of trial subjects
    This study was conducted according to the principles of Good Clinical Practices (GCP) as described in the International Conference on Harmonisation (ICH) document, Guidance for Industry-E6, Good Clinical Practice: Consolidated Guidance, and in keeping with local legal and regulatory requirements and the Declaration of Helsinki as currently endorsed by regional regulatory health authorities.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    31 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    United States: 54
    Worldwide total number of subjects
    63
    EEA total number of subjects
    6
    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)
    54
    From 65 to 84 years
    9
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Participants were screened based on the the diagnosis of SSc which was based on the American College of Rheumatology, with SSc disease duration less than (<) 7 years. The diagnosis of SSc-ILD was to be confirmed by a high-resolution computed tomography scan (obtained 2 years before written informed consent).

    Period 1
    Period 1 title
    Overall 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
    		 Pirfenidone: 4-Week Titration Group
    Arm description
    		 Participants received one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day [mg/day]) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pirfenidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).

    Arm title
    		 Pirfenidone: 2-Week Titration Group
    Arm description
    		 Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pirfenidone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).

    Number of subjects in period 1
    		Pirfenidone: 4-Week Titration Group Pirfenidone: 2-Week Titration Group
    Started
    31
    32
    Completed
    29
    27
    Not completed
    2
    5
         Consent withdrawn by subject
    1
    -
         Adverse event
    1
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Pirfenidone: 4-Week Titration Group
    Reporting group description
    		 Participants received one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day [mg/day]) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).

    Reporting group title
    Pirfenidone: 2-Week Titration Group
    Reporting group description
    		 Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).

    Reporting group values
    		 Pirfenidone: 4-Week Titration Group Pirfenidone: 2-Week Titration Group Total
    Number of subjects
    		 31 32 63
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 51.9 ± 12.52 49.3 ± 12.08 -
    Gender categorical
    Units: Subjects
        Female
    		 26 26 52
        Male
    		 5 6 11

    End points

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    End points reporting groups
    Reporting group title
    Pirfenidone: 4-Week Titration Group
    Reporting group description
    		 Participants received one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day [mg/day]) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).

    Reporting group title
    Pirfenidone: 2-Week Titration Group
    Reporting group description
    		 Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).

    Primary: Percentage of Participants With Treatment-Emergent Adverse Events (AEs)

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    End point title
    		 Percentage of Participants With Treatment-Emergent Adverse Events (AEs) [1]
    End point description
    Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category. Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.
    End point type
    Primary
    End point timeframe
    From baseline up to 28 days after the last dose of study drug (last dose = Week 16)
    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: No statistical analysis was planned for the safety endpoint.
    End point values
    		 Pirfenidone: 4-Week Titration Group Pirfenidone: 2-Week Titration Group
    Number of subjects analysed
    31
    32
    Units: percentage of participants
        number (not applicable)
    96.8
    96.9
    No statistical analyses for this end point

    Primary: Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs) [2]
    End point description
    An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Safety Population.
    End point type
    Primary
    End point timeframe
    From baseline up to 28 days after the last dose of study drug (last dose = Week 16)
    Notes
    [2] - 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: No statistical analysis was planned for the safety endpoint.
    End point values
    		 Pirfenidone: 4-Week Titration Group Pirfenidone: 2-Week Titration Group
    Number of subjects analysed
    31
    32
    Units: percentage of participants
        number (not applicable)
    0
    9.4
    No statistical analyses for this end point

    Secondary: University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores

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    End point title
    		 University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores
    End point description
    UCLA SCTC GIT Scale 2.0 is a 34-item self-administered questionnaire to obtain participant's assessment of frequency of GI symptoms in preceding 7 days and how symptoms affected his/her life. All but 2 items were scored on a 0-3 scale (0=better health, 3=worse health); remaining 2 items were scored as 0 (better health), 1 (worse health). The 34 items are divided into 7 scales (reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being, and constipation). Individual scale score was calculated as the average of items in scale. Individual scale score ranged from 0-3 for reflux, distention/bloating, fecal soilage, social functioning, and emotional well-being; 0-2 for diarrhea; and 0-2.5 for constipation. A total score was also calculated as average of 6 of 7 scales (omitting constipation) and ranged from 0-2.83. For individual and total scores 0 indicated better health and higher score indicates worse health. Safety Population. CFB=change from baseline.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 4, 8, 12, and 16
    End point values
    		 Pirfenidone: 4-Week Titration Group Pirfenidone: 2-Week Titration Group
    Number of subjects analysed
    31 [3]
    32 [4]
    Units: units on a scale
    arithmetic mean (standard deviation)
        Reflux: Baseline (n=31, 32)
    0.3347 ± 0.29117
    0.3398 ± 0.34083
        Reflux: Week 4 (n=31, 32)
    0.3548 ± 0.36529
    0.4727 ± 0.4327
        Reflux: CFB Week 4 (n=31, 32)
    0.0202 ± 0.26437
    0.1328 ± 0.36469
        Reflux: Week 8 (n=31, 32)
    0.4389 ± 0.46573
    0.466 ± 0.39881
        Reflux: CFB Week 8 (n=31, 32)
    0.1043 ± 0.41664
    0.1261 ± 0.36875
        Reflux: Week 12 (n=30, 27)
    0.3417 ± 0.33142
    0.4306 ± 0.41069
        Reflux: CFB Week 12 (n=30, 27)
    0.0042 ± 0.26155
    0.088 ± 0.35494
        Reflux: Week 16 (n=28, 25)
    0.3348 ± 0.39682
    0.395 ± 0.3727
        Reflux: CFB Week 16 (n=28, 25)
    -0.0045 ± 0.3182
    0.075 ± 0.25259
        Distention/Bloating: Baseline (n=31, 32)
    0.5968 ± 0.58693
    0.3984 ± 0.571
        Distention/Bloating: Week 4 (n=31, 32)
    0.4919 ± 0.65346
    0.6406 ± 0.65049
        Distention/Bloating: CFB Week 4 (n=31, 32)
    -0.1048 ± 0.50734
    0.2422 ± 0.41874
        Distention/Bloating: Week 8 (n=31, 32)
    0.4247 ± 0.57188
    0.5703 ± 0.60985
        Distention/Bloating: CFB Week 8 (n=31, 32)
    -0.172 ± 0.43245
    0.1719 ± 0.4728
        Distention/Bloating: Week 12 (n=30, 27)
    0.425 ± 0.56152
    0.537 ± 0.7061
        Distention/Bloating: CFB Week 12 (n=30, 27)
    -0.1833 ± 0.47766
    0.213 ± 0.59929
        Distention/Bloating: Week 16 (n=28, 25)
    0.4286 ± 0.48523
    0.48 ± 0.61627
        Distention/Bloating: CFB Week 16 (n=28, 25)
    -0.1518 ± 0.45307
    0.12 ± 0.45139
        Diarrhea: Baseline (n=31, 32)
    0.2742 ± 0.48026
    0.3281 ± 0.48542
        Diarrhea: Week 4 (n=31, 32)
    0.2258 ± 0.48026
    0.3125 ± 0.48775
        Diarrhea: CFB Week 4 (n=31, 32)
    -0.0484 ± 0.43503
    -0.0156 ± 0.5748
        Diarrhea: Week 8 (n=31, 32)
    0.3226 ± 0.556
    0.2813 ± 0.37968
        Diarrhea: CFB Week 8 (n=31, 32)
    0.0484 ± 0.58245
    -0.0469 ± 0.46419
        Diarrhea: Week 12 (n=30, 27)
    0.2 ± 0.48423
    0.2778 ± 0.46685
        Diarrhea: CFB Week 12 (n=30, 27)
    -0.0667 ± 0.58329
    -0.0556 ± 0.56045
        Diarrhea: Week 16 (n=28, 25)
    0.25 ± 0.51819
    0.34 ± 0.51478
        Diarrhea: CFB Week 16 (n=28, 25)
    -0.0179 ± 0.61587
    0.04 ± 0.57591
        Social Functioning: Baseline (n=31, 32)
    0.1893 ± 0.43585
    0.125 ± 0.28078
        Social Functioning: Week 4 (n=31, 32)
    0.1775 ± 0.27199
    0.1563 ± 0.26072
        Social Functioning: CFB Week 4 (n=31, 32)
    -0.0118 ± 0.28143
    0.0313 ± 0.25893
        Social Functioning: Week 8 (n=31, 32)
    0.1936 ± 0.33647
    0.1886 ± 0.31322
        Social Functioning: CFB Week 8 (n=31, 32)
    0.0044 ± 0.37997
    0.0635 ± 0.29233
        Social Functioning: Week 12 (n=30, 27)
    0.1944 ± 0.30028
    0.1173 ± 0.23488
        Social Functioning: CFB Week 12 (n=30, 27)
    -0.0011 ± 0.3573
    0.0432 ± 0.25154
        Social Functioning: Week 16 (n=28, 25)
    0.01667 ± 0.27596
    0.06 ± 0.13502
        Social Functioning: CFB Week 16 (n=28, 25)
    -0.0131 ± 0.40515
    0.0133 ± 0.16607
        Emotional Wellbeing: Baseline (n=31, 32)
    0.1326 ± 0.4191
    0.0937 ± 0.26033
        Emotional Wellbeing: Week 4 (n=30, 32)
    0.0778 ± 0.32516
    0.0937 ± 0.21697
        Emotional Wellbeing: CFB Week 4 (n=30, 32)
    -0.0593 ± 0.14808
    0 ± 0.17831
        Emotional Wellbeing: Week 8 (n=31, 32)
    0.0825 ± 0.2968
    0.1181 ± 0.33273
        Emotional Wellbeing: CFB Week 8 (n=31, 32)
    -0.0502 ± 0.19846
    0.0243 ± 0.11887
        Emotional Wellbeing: Week 12 (n=30, 27)
    0.0852 ± 0.30979
    0.0493 ± 0.13182
        Emotional Wellbeing: CFB Week 12 (n=30, 27)
    -0.0482 ± 0.14786
    0.0123 ± 0.12055
        Emotional Wellbeing: Week 16 (n=28, 25)
    0.0833 ± 0.39959
    0.0266 ± 0.0803
        Emotional Wellbeing: CFB Week 16 (n=28, 25)
    -0.0357 ± 0.12851
    0 ± 0.10627
        Fecal Soilage: Baseline (n=31, 32)
    0.129 ± 0.42755
    0.0313 ± 0.17678
        Fecal Soilage: Week 4 (n=31, 32)
    0.129 ± 0.42755
    0.0313 ± 0.17678
        Fecal Soilage: CFB Week 4 (n=31, 32)
    0 ± 0
    0 ± 0
        Fecal Soilage: Week 8 (n=31, 32)
    0.1613 ± 0.45437
    0.0313 ± 0.17678
        Fecal Soilage: CFB Week 8 (n=31, 32)
    0.0323 ± 0.17961
    0 ± 0
        Fecal Soilage: Week 12 (n=30, 27)
    0.1333 ± 0.43417
    0.037 ± 0.19245
        Fecal Soilage: CFB Week 12 (n=30, 27)
    0 ± 0
    0.037 ± 0.19245
        Fecal Soilage: Week 16 (n=28, 25)
    0.1071 ± 0.41627
    0.04 ± 0.2
        Fecal Soilage: CFB Week 16 (n=28, 25)
    0 ± 0
    0.04 ± 0.2
        Constipation: Baseline (n=31, 32)
    0.1694 ± 0.2613
    0.2422 ± 0.40899
        Constipation: Week 4 (n=30, 32)
    0.15 ± 0.29066
    0.2656 ± 0.34159
        Constipation: CFB Week 4 (n=30, 32)
    -0.025 ± 0.30336
    0.0234 ± 0.42293
        Constipation: Week 8 (n=31, 32)
    0.1613 ± 0.46345
    0.2578 ± 0.39901
        Constipation: CFB Week 8 (n=31, 32)
    -0.0081 ± 0.38989
    0.0156 ± 0.2535
        Constipation: Week 12 (n=30, 27)
    0.2111 ± 0.36075
    0.2407 ± 0.38904
        Constipation: CFB Week 12 (n=30, 27)
    0.0528 ± 0.49008
    0.037 ± 0.37148
        Constipation: Week 16 (n=28, 25)
    0.1518 ± 0.27504
    0.18 ± 0.29333
        Constipation: CFB Week 16 (n=28, 25)
    -0.0179 ± 0.42453
    0.02 ± 0.37444
        Total Score: Baseline (n=32, 31)
    0.2761 ± 0.32679
    0.2194 ± 0.24262
        Total Score: Week 4 (n=32, 31)
    0.2432 ± 0.31264
    0.2845 ± 0.28528
        Total Score: CFB Week 4 (n=32, 31)
    -0.033 ± 0.13591
    0.0651 ± 0.20058
        Total Score: Week 8 (n=32, 31)
    0.2706 ± 0.29132
    0.2759 ± 0.26133
        Total Score: CFB Week 8 (n=32, 31)
    -0.0055 ± 0.20053
    0.0564 ± 0.15749
        Total Score: Week 12 (n=27, 30)
    0.2299 ± 0.27136
    0.2416 ± 0.25329
        Total Score: CFB Week 12 (n=27, 30)
    -0.0492 ± 0.17709
    0.0564 ± 0.1679
        Total Score: Week 16 (n=25, 28)
    0.2284 ± 0.26906
    0.2237 ± 0.19767
        Total Score: CFB Week 16 (n=25, 28)
    -0.0372 ± 0.20737
    0.0481 ± 0.14444
    Notes
    [3] - n = number of participants analyzed at specified time
    [4] - n = number of participants analyzed at specified time
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline up to 28 days after the last dose of study drug (last dose = Week 16)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Pirfenidone: 2-Week Titration Group
    Reporting group description
    		 Participants received one 267 mg oral pirfenidone capsule (801 mg/day) TID for 1 week followed by two 267 mg oral pirfenidone capsules (1602 mg/day) TID for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).

    Reporting group title
    Pirfenidone: 4-Week Titration Group
    Reporting group description
    		 Participants received one 267 mg oral pirfenidone capsule (801 mg/day) TID for 2 weeks followed by two 267 mg oral pirfenidone capsules (1602 mg/day) TID for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).

    Serious adverse events
    		 Pirfenidone: 2-Week Titration Group Pirfenidone: 4-Week Titration Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 31 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Small intestinal obstruction
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Interstitial lung disease
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 32 (3.13%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pirfenidone: 2-Week Titration Group Pirfenidone: 4-Week Titration Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 32 (96.88%)
    30 / 31 (96.77%)
    Vascular disorders
    Hot flush
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Hypotension
         subjects affected / exposed
    3 / 32 (9.38%)
    0 / 31 (0.00%)
         occurrences all number
    3
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    2 / 32 (6.25%)
    5 / 31 (16.13%)
         occurrences all number
    3
    6
    Chest discomfort
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Chills
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Fatigue
         subjects affected / exposed
    13 / 32 (40.63%)
    10 / 31 (32.26%)
         occurrences all number
    18
    12
    Oedema peripheral
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 31 (3.23%)
         occurrences all number
    4
    2
    Pyrexia
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 32 (31.25%)
    4 / 31 (12.90%)
         occurrences all number
    11
    4
    Dysphonia
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Dyspnoea
         subjects affected / exposed
    3 / 32 (9.38%)
    4 / 31 (12.90%)
         occurrences all number
    3
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    2 / 32 (6.25%)
    5 / 31 (16.13%)
         occurrences all number
    3
    7
    Investigations
    Weight decreased
         subjects affected / exposed
    3 / 32 (9.38%)
    1 / 31 (3.23%)
         occurrences all number
    3
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 32 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    0
    3
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    3 / 32 (9.38%)
    2 / 31 (6.45%)
         occurrences all number
    4
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    5 / 32 (15.63%)
    5 / 31 (16.13%)
         occurrences all number
    6
    5
    Headache
         subjects affected / exposed
    14 / 32 (43.75%)
    14 / 31 (45.16%)
         occurrences all number
    18
    19
    Hypoaesthesia
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    4 / 32 (12.50%)
    2 / 31 (6.45%)
         occurrences all number
    4
    2
    Abdominal pain
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
         occurrences all number
    1
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
         occurrences all number
    2
    2
    Constipation
         subjects affected / exposed
    5 / 32 (15.63%)
    2 / 31 (6.45%)
         occurrences all number
    6
    3
    Diarrhoea
         subjects affected / exposed
    9 / 32 (28.13%)
    10 / 31 (32.26%)
         occurrences all number
    14
    11
    Dry mouth
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Dyspepsia
         subjects affected / exposed
    4 / 32 (12.50%)
    4 / 31 (12.90%)
         occurrences all number
    6
    5
    Flatulence
         subjects affected / exposed
    2 / 32 (6.25%)
    1 / 31 (3.23%)
         occurrences all number
    2
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 32 (18.75%)
    7 / 31 (22.58%)
         occurrences all number
    7
    10
    Nausea
         subjects affected / exposed
    16 / 32 (50.00%)
    15 / 31 (48.39%)
         occurrences all number
    18
    19
    Stomach discomfort
         subjects affected / exposed
    3 / 32 (9.38%)
    4 / 31 (12.90%)
         occurrences all number
    3
    5
    Vomiting
         subjects affected / exposed
    9 / 32 (28.13%)
    9 / 31 (29.03%)
         occurrences all number
    9
    11
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
         occurrences all number
    1
    3
    Photosensitivity reaction
         subjects affected / exposed
    2 / 32 (6.25%)
    2 / 31 (6.45%)
         occurrences all number
    3
    2
    Pruritus
         subjects affected / exposed
    4 / 32 (12.50%)
    4 / 31 (12.90%)
         occurrences all number
    5
    5
    Rash
         subjects affected / exposed
    8 / 32 (25.00%)
    5 / 31 (16.13%)
         occurrences all number
    10
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    5 / 32 (15.63%)
    4 / 31 (12.90%)
         occurrences all number
    5
    6
    Back pain
         subjects affected / exposed
    5 / 32 (15.63%)
    3 / 31 (9.68%)
         occurrences all number
    6
    4
    Joint swelling
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Muscle spasms
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Musculoskeletal pain
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Myalgia
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Pain in extremity
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2
    Infections and infestations
    Influenza
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 31 (9.68%)
         occurrences all number
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    3 / 32 (9.38%)
    2 / 31 (6.45%)
         occurrences all number
    3
    2
    Pneumonia
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Sinusitis
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 32 (3.13%)
    3 / 31 (9.68%)
         occurrences all number
    1
    3
    Urinary tract infection
         subjects affected / exposed
    0 / 32 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    2
    Gastroenteritis viral
         subjects affected / exposed
    2 / 32 (6.25%)
    0 / 31 (0.00%)
         occurrences all number
    2
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    5 / 32 (15.63%)
    2 / 31 (6.45%)
         occurrences all number
    5
    3
    Decreased appetite
         subjects affected / exposed
    1 / 32 (3.13%)
    2 / 31 (6.45%)
         occurrences all number
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jan 2014
    This amendment was done to include a change of mycophenolate mofetil to mycophenolate which is inclusive of mycophenolate mofetil or mycophenolate acid. Additional global changes included an administrative change to clarify the Mahler Dyspnea Index includes the Baseline Dyspnea Index (BDI) in addition to the Translational Dyspnea Index (TDI) as part of it standard assessment.

    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
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    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.

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