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    Clinical Trial Results:
    Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron Plus REBETOL for Pediatric Patients with Chronic Hepatitis C

    Summary
    EudraCT number
    		 2004-000558-22
    Trial protocol
    		 IT   ES   Outside EU/EEA  
    Global end of trial date
    10 Jan 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    21 Feb 2016
    First version publication date
    21 Jan 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    P02538: Part 2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00761735
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol Number: P02538: Part 2
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, New Jersey, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000071-PIP01-07 EMEA-000384-PIP01-08
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jan 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Jan 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Feb 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety
    Long term follow-up duration
    		 5 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Spain: 21
    Country: Number of subjects enrolled
    Germany: 11
    Country: Number of subjects enrolled
    Austria: 3
    Country: Number of subjects enrolled
    United States: 32
    Country: Number of subjects enrolled
    Puerto Rico: 2
    Country: Number of subjects enrolled
    Argentina: 15
    Country: Number of subjects enrolled
    Chile: 1
    Country: Number of subjects enrolled
    France: 11
    Worldwide total number of subjects
    107
    EEA total number of subjects
    57
    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)
    67
    Adolescents (12-17 years)
    40
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 The Treatment and Follow-up Period 1 enrolled participants 3 to 17 years old with untreated, chronic hepatitis C virus (HCV) of any genotype. Other inclusion and exclusion criteria applied. The Long-term Follow-up (LTFU) Period 2 enrolled participants who received >=1 dose of study drug and completed the 24-week post-treatment follow-up

    Period 1
    Period 1 title
    Treatment and Follow-up Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PEG-Intron plus REBETOL (Treatment and Follow-up Period 1)
    Arm description
    		 Participants received PEG-Intron (peginterferon alfa-2b, SCH 54031) 60 µg/m^2 subcutaneous injection once weekly plus REBETOL (ribavirin, SCH 18908) 15 mg/kg by mouth daily in two divided doses for 48 weeks for participants with Genotypes 1,4,5,6 and for participants with Genotype 3 with a high viral load (≥600,000 IU/mL). For participants with Genotype 2, or participants with Genotype 3 with a low viral load (<600,000 IU/mL), the same treatment was given for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rebetol
    Investigational medicinal product code
    J05AB04
    Other name
    Ribavirin, SCH 18908
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received REBETOL 15 mg/kg by mouth daily in two divided doses for 48 weeks for participants with Genotypes 1,4,5,6 and for participants with Genotype 3 with a high viral load (≥600,000 IU/mL). For participants with Genotype 2, or participants with Genotype 3 with a low viral load (<600,000 IU/mL), the same treatment was given for 24 weeks.

    Investigational medicinal product name
    PegIntron
    Investigational medicinal product code
    L03AB10
    Other name
    peginterferon alfa-2b, SCH 54031
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Participants received PEG-Intron 60 µg/m^2 by subcutaneous injection once weekly for 48 weeks for participants with Genotypes 1,4,5,6 and for participants with Genotype 3 with a high viral load (≥600,000 IU/mL). For participants with Genotype 2, or participants with Genotype 3 with a low viral load (<600,000 IU/mL), the same treatment was given for 24 weeks

    Number of subjects in period 1
    		PEG-Intron plus REBETOL (Treatment and Follow-up Period 1)
    Started
    107
    Participants who completed treatment
    78 [1]
    Completed
    106
    Not completed
    1
         Did not enter follow-up for unknown reason
    1
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This is the number of participants who completed the treatment regimen. Completion of treatment was not a requirement to complete the Treatment and Follow-up Period 1.
    Period 2
    Period 2 title
    Long-term Follow-up Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 PEG-Intron plus REBETOL (Long Term Follow-up Period 2)
    Arm description
    		 Participants who received >=1 dose of PEG-Intron plus REBETOL and completed the 24-week follow-up in the Treatment and Follow-up Period 1 were eligible to enroll in the 5-year LTFU Period of the study. No study treatment was administered in the LTFU Period 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rebetol
    Investigational medicinal product code
    J05AB04
    Other name
    Ribavirin, SCH 18908
    Pharmaceutical forms
    Capsule, Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    In the Treatment and Follow-up Period, participants received REBETOL 15 mg/kg by mouth daily in two divided doses for 48 weeks for participants with Genotypes 1,4,5,6 and for participants with Genotype 3 with a high-viral-load (≥600,000 IU/mL). For participants with Genotype 2, or participants with Genotype 3 with a low-viral-load (<600,000 IU/mL), the same treatment was given for 24 weeks. No study treatment was administered during the LTFU Period.

    Investigational medicinal product name
    PegIntron
    Investigational medicinal product code
    L03AB10
    Other name
    peginterferon alfa-2b, SCH 54031
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In the Treatment and Follow-up Period, participants received PEG-Intron 60 µg/m^2 by subcutaneous injection once weekly for 48 weeks for participants with Genotypes 1,4,5,6 and for participants with Genotype 3 with a high-viral-load (≥600,000 IU/mL). For participants with Genotype 2, or participants with Genotype 3 with a low-viral-load (<600,000 IU/mL), the same treatment was given for 24 weeks. No study treatment was administered during the LTFU Period.

    Number of subjects in period 2 [2]
    		PEG-Intron plus REBETOL (Long Term Follow-up Period 2)
    Started
    94
    Completed
    80
    Not completed
    14
         Consent withdrawn by subject
    6
         Administrative
    1
         Lost to follow-up
    6
         Protocol deviation
    1
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Enrollment in the LTFU Period 2 was optional. Not all eligible participants enrolled in the LTFU Period 2.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PEG-Intron plus REBETOL (Treatment and Follow-up Period 1)
    Reporting group description
    		 Participants received PEG-Intron (peginterferon alfa-2b, SCH 54031) 60 µg/m^2 subcutaneous injection once weekly plus REBETOL (ribavirin, SCH 18908) 15 mg/kg by mouth daily in two divided doses for 48 weeks for participants with Genotypes 1,4,5,6 and for participants with Genotype 3 with a high viral load (≥600,000 IU/mL). For participants with Genotype 2, or participants with Genotype 3 with a low viral load (<600,000 IU/mL), the same treatment was given for 24 weeks.

    Reporting group values
    		 PEG-Intron plus REBETOL (Treatment and Follow-up Period 1) Total
    Number of subjects
    		 107 107
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 67 67
        Adolescents (12-17 years)
    		 40 40
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 9.7 ( 4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 56 56
        Male
    		 51 51

    End points

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    End points reporting groups
    Reporting group title
    PEG-Intron plus REBETOL (Treatment and Follow-up Period 1)
    Reporting group description
    		 Participants received PEG-Intron (peginterferon alfa-2b, SCH 54031) 60 µg/m^2 subcutaneous injection once weekly plus REBETOL (ribavirin, SCH 18908) 15 mg/kg by mouth daily in two divided doses for 48 weeks for participants with Genotypes 1,4,5,6 and for participants with Genotype 3 with a high viral load (≥600,000 IU/mL). For participants with Genotype 2, or participants with Genotype 3 with a low viral load (<600,000 IU/mL), the same treatment was given for 24 weeks.
    Reporting group title
    PEG-Intron plus REBETOL (Long Term Follow-up Period 2)
    Reporting group description
    		 Participants who received >=1 dose of PEG-Intron plus REBETOL and completed the 24-week follow-up in the Treatment and Follow-up Period 1 were eligible to enroll in the 5-year LTFU Period of the study. No study treatment was administered in the LTFU Period 2.

    Subject analysis set title
    PEG-Intron plus REBETOL 24 Weeks
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who received >=1 dose of PEG-Intron plus REBETOL in the 24-week treatment group and completed the 24-week follow-up in the Treatment and Follow-up Period 1 were eligible to enroll in the 5-year LTFU Period 2 of the study. No study treatment was administered in the LTFU Period 2.

    Subject analysis set title
    PEG-Intron plus REBETOL 48 weeks
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants who received >=1 dose of PEG-Intron plus REBETOL in the 48-week treatment group and completed the 24-week follow-up in the Treatment and Follow-up Period 1 were eligible to enroll in the 5-year LTFU Period 2 of the study. No study treatment was administered in the LTFU Period 2.

    Subject analysis set title
    PEG-Intron plus REBETOL Females
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Female participants who received >=1 dose of PEG-Intron plus REBETOL and completed the 24-week follow-up in the Treatment and Follow-up Period 1 were eligible to enroll in the 5-year LTFU Period 2 of the study. No study treatment was administered in the LTFU Period 2.

    Subject analysis set title
    PEG-Intron plus REBETOL Males
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Male participants who received >=1 dose of PEG-Intron plus REBETOL and completed the 24-week follow-up in the Treatment and Follow-up Period 1 were eligible to enroll in the 5-year LTFU Period 2 of the study. No study treatment was administered in the LTFU Period 2.

    Primary: Number of Participants with a Sustained Virologic Response

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    End point title
    		 Number of Participants with a Sustained Virologic Response [1]
    End point description
    Sustained virologic response was defined as undetectable plasma HCV RNA at 24 weeks post-treatment
    End point type
    Primary
    End point timeframe
    24 weeks after end of treatment (up to 72 weeks)
    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 between-group statistical analysis was conducted for Number of Participants with a Sustained Virologic Response
    End point values
    		 PEG-Intron plus REBETOL (Treatment and Follow-up Period 1)
    Number of subjects analysed
    107
    Units: Participants
    70
    No statistical analyses for this end point

    Primary: Number of Participants Who Relapsed

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    End point title
    		 Number of Participants Who Relapsed [2]
    End point description
    Relapse was defined as undetectable plasma HCV RNA at the last treatment visit and plasma HCV RNA above the lower limit of quantification at the last follow-up visit in the LTFU Period 2
    End point type
    Primary
    End point timeframe
    End of LTFU Period 2 (5 years)
    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 conducted for Number of Participants who Relapsed
    End point values
    		 PEG-Intron plus REBETOL (Long Term Follow-up Period 2)
    Number of subjects analysed
    54 [3]
    Units: Participants
    0
    Notes
    [3] - Participants with sustained virologic response at the last treatment visit and completing LTFU
    No statistical analyses for this end point

    Primary: Mean Height Percentile

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    End point title
    		 Mean Height Percentile [4]
    End point description
    To determine long-term effects of treatment on height, changes in height during LTFU Period 2 were evaluated using height percentiles based on 2000 Centers for Disease Control growth charts for the general population
    End point type
    Primary
    End point timeframe
    Treatment and Follow-up Period 1: pre-treatment baseline; LTFU Period 2: year 1, year 2, year 3, year 4, year 5, and last available visit up to year 5
    Notes
    [4] - 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 conducted for Mean Height Percentile
    End point values
    		 PEG-Intron plus REBETOL 24 Weeks PEG-Intron plus REBETOL 48 weeks
    Number of subjects analysed
    46
    48
    Units: Percentile of participants
    arithmetic mean (standard deviation)
        Pre-treatment baseline
    48.94 ( 27.38 )
    52.5 ( 29.98 )
        Year 1 (N=40, 44)
    49.21 ( 29.03 )
    43.37 ( 27.87 )
        Year 2 (N=39, 39)
    50.56 ( 29.18 )
    46.24 ( 29.19 )
        Year 3 (N=39, 44)
    48.05 ( 28.38 )
    46 ( 28.24 )
        Year 4 (N=40, 38)
    49.62 ( 30.87 )
    45.27 ( 29.44 )
        Year 5 (N=38, 42)
    47.61 ( 29.57 )
    43.51 ( 27.57 )
        Last available visit (N=46, 48)
    45.96 ( 30.45 )
    43.56 ( 27.19 )
    No statistical analyses for this end point

    Primary: Mean Weight Percentile

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    End point title
    		 Mean Weight Percentile [5]
    End point description
    To determine long-term effects of treatment on weight, changes in weight during LTFU Period 2 were evaluated using weight percentiles based on the 2000 Centers for Disease Control growth charts for the general population
    End point type
    Primary
    End point timeframe
    Treatment and Follow-up Period 1: pre-treatment baseline; LTFU Period 2: year 1, year 2, year 3, year 4, year 5, and last available visit up to year 5
    Notes
    [5] - 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 conducted for Mean Weight Percentile
    End point values
    		 PEG-Intron plus REBETOL 24 Weeks PEG-Intron plus REBETOL 48 weeks
    Number of subjects analysed
    46
    48
    Units: Percentile of participants
    arithmetic mean (standard deviation)
        Pre-treatment baseline
    52.5 ( 26.83 )
    58.56 ( 30.56 )
        Year 1 (N=40, 44)
    53.62 ( 26.75 )
    56.38 ( 30.55 )
        Year 2 (N=39, 39)
    51.73 ( 26.89 )
    52.03 ( 30.47 )
        Year 3 (N=39, 44)
    53.18 ( 29.12 )
    54.26 ( 30.37 )
        Year 4 (N=40, 38)
    51.75 ( 28.9 )
    49.5 ( 30.37 )
        Year 5 (N=38, 42)
    51.16 ( 27.16 )
    53.12 ( 31.38 )
        Last available visit (N=46, 48)
    50.15 ( 28.44 )
    55.53 ( 30.67 )
    No statistical analyses for this end point

    Primary: Mean Body Mass Index Percentile

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    End point title
    		 Mean Body Mass Index Percentile [6]
    End point description
    To determine long-term effects of treatment on Body Mass Index (BMI), changes in BMI during LTFU Period 2 were evaluated using BMI percentiles base on 2000 Centers for Disease Control growth charts for the general population
    End point type
    Primary
    End point timeframe
    Treatment and Follow-up Period 1: pre-treatment baseline; LTFU Period ): year 1, year 2, year 3, year 4, year 5, and last available visit up to year 5
    Notes
    [6] - 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 conducted for Mean Body Mass Index Percentile
    End point values
    		 PEG-Intron plus REBETOL 24 Weeks PEG-Intron plus REBETOL 48 weeks
    Number of subjects analysed
    46
    48
    Units: Percentile of participants
    arithmetic mean (standard deviation)
        Pre-treatment baseline
    50.4 ( 29.63 )
    59.76 ( 31.52 )
        Year 1 (N=40, 44)
    51.15 ( 30.27 )
    59.91 ( 31.55 )
        Year 2 (N=39, 39)
    48.11 ( 29.59 )
    52.89 ( 30.82 )
        Year 3 (N=39, 44)
    52.14 ( 31 )
    54.96 ( 30.89 )
        Year 4 (N=40, 38)
    48.44 ( 30.46 )
    48.69 ( 31.52 )
        Year 5 (N=38, 42)
    48.61 ( 29.72 )
    52.34 ( 31.87 )
        Last available visit (N=46, 48)
    48.79 ( 29.4 )
    55.38 ( 31.48 )
    No statistical analyses for this end point

    Primary: Mean Age at Attained Tanner Stage

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    End point title
    		 Mean Age at Attained Tanner Stage [7]
    End point description
    The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants were evaluated for breast development and pubic hair distribution and male participants were evaluated for genital development and pubic hair distribution based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of Period 2 long-term follow-up (last observation), females and males were staged and the mean age at each TS attained was reported.
    End point type
    Primary
    End point timeframe
    Last observation during LTFU Period 2 (up to 5 years)
    Notes
    [7] - 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 conducted for Mean Age at Attained Tanner Stage
    End point values
    		 PEG-Intron plus REBETOL Females PEG-Intron plus REBETOL Males
    Number of subjects analysed
    41 [8]
    42 [9]
    Units: Years
    arithmetic mean (standard deviation)
        Tanner Stage 1 (N=4, 5)
    9.75 ( 1.13 )
    11 ( 0.8 )
        Tanner Stage 2 (N=5, 3)
    11.86 ( 0.78 )
    12.53 ( 1.27 )
        Tanner Stage 3 (N=7, 1)
    15.26 ( 4.64 )
    13.6 ( 0 )
        Tanner Stage 4 (N=4, 6)
    16 ( 4.31 )
    14.75 ( 1.47 )
        Tanner Stage 5 (N=21, 27)
    17.37 ( 2.71 )
    19.18 ( 2.48 )
    Notes
    [8] - Participants with a non-missing Tanner Stage at the last observation
    [9] - Participants with a non-missing Tanner Stage at the last observation
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious AEs: Beginning of Screening to the end of the LTFU Period 2 (up to 336 weeks) Non-serious AEs: Day 1 to the end of Treatment and Follow-up Period 1 (up to 72 weeks). Non-serious AEs were not collected in the LTFU Period 2.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    PEG-Intron plus REBETOL
    Reporting group description
    		 Participants received PEG-Intron (peginterferon alfa-2b, SCH 54031) 60 µg/m^2 subcutaneous injection once weekly plus REBETOL (ribavirin, SCH 18908) 15 mg/kg by mouth daily in two divided doses for 48 weeks for participants with Genotypes 1,4,5,6 and for participants with Genotype 3 with a high-viral-load (≥600,000 IU/mL). For participants with Genotype 2, or participants with Genotype 3 with a low-viral-load (<600,000 IU/mL), the same treatment was given for 24 weeks.

    Serious adverse events
    		 PEG-Intron plus REBETOL
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 107 (5.61%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Carbon monoxide poisoning
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Fall
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Congenital, familial and genetic disorders
    Talipes
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 107 (0.93%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    2 / 107 (1.87%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PEG-Intron plus REBETOL
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    107 / 107 (100.00%)
    Investigations
    Blood thyroid stimulating hormone increased
         subjects affected / exposed
    6 / 107 (5.61%)
         occurrences all number
    9
    Weight decreased
         subjects affected / exposed
    20 / 107 (18.69%)
         occurrences all number
    29
    Nervous system disorders
    Headache
         subjects affected / exposed
    71 / 107 (66.36%)
         occurrences all number
    410
    Dizziness
         subjects affected / exposed
    15 / 107 (14.02%)
         occurrences all number
    25
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    86 / 107 (80.37%)
         occurrences all number
    617
    Asthenia
         subjects affected / exposed
    16 / 107 (14.95%)
         occurrences all number
    40
    Chills
         subjects affected / exposed
    23 / 107 (21.50%)
         occurrences all number
    58
    Fatigue
         subjects affected / exposed
    32 / 107 (29.91%)
         occurrences all number
    125
    Influenza like illness
         subjects affected / exposed
    10 / 107 (9.35%)
         occurrences all number
    51
    Injection site erythema
         subjects affected / exposed
    31 / 107 (28.97%)
         occurrences all number
    50
    Irritability
         subjects affected / exposed
    16 / 107 (14.95%)
         occurrences all number
    42
    Malaise
         subjects affected / exposed
    10 / 107 (9.35%)
         occurrences all number
    24
    Pain
         subjects affected / exposed
    10 / 107 (9.35%)
         occurrences all number
    20
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    12 / 107 (11.21%)
         occurrences all number
    20
    Leukopenia
         subjects affected / exposed
    11 / 107 (10.28%)
         occurrences all number
    15
    Lymphadenopathy
         subjects affected / exposed
    10 / 107 (9.35%)
         occurrences all number
    14
    Neutropenia
         subjects affected / exposed
    35 / 107 (32.71%)
         occurrences all number
    61
    Eye disorders
    Eye pain
         subjects affected / exposed
    6 / 107 (5.61%)
         occurrences all number
    7
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    15 / 107 (14.02%)
         occurrences all number
    24
    Abdominal pain
         subjects affected / exposed
    28 / 107 (26.17%)
         occurrences all number
    58
    Aphthous stomatitis
         subjects affected / exposed
    6 / 107 (5.61%)
         occurrences all number
    12
    Diarrhoea
         subjects affected / exposed
    16 / 107 (14.95%)
         occurrences all number
    20
    Nausea
         subjects affected / exposed
    22 / 107 (20.56%)
         occurrences all number
    41
    Vomiting
         subjects affected / exposed
    36 / 107 (33.64%)
         occurrences all number
    76
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    7 / 107 (6.54%)
         occurrences all number
    10
    Cough
         subjects affected / exposed
    24 / 107 (22.43%)
         occurrences all number
    31
    Oropharyngeal pain
         subjects affected / exposed
    15 / 107 (14.02%)
         occurrences all number
    20
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    6 / 107 (5.61%)
         occurrences all number
    6
    Alopecia
         subjects affected / exposed
    19 / 107 (17.76%)
         occurrences all number
    21
    Dry skin
         subjects affected / exposed
    15 / 107 (14.02%)
         occurrences all number
    19
    Eczema
         subjects affected / exposed
    8 / 107 (7.48%)
         occurrences all number
    9
    Erythema
         subjects affected / exposed
    8 / 107 (7.48%)
         occurrences all number
    9
    Rash
         subjects affected / exposed
    8 / 107 (7.48%)
         occurrences all number
    14
    Psychiatric disorders
    Nervousness
         subjects affected / exposed
    9 / 107 (8.41%)
         occurrences all number
    9
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    18 / 107 (16.82%)
         occurrences all number
    70
    Back pain
         subjects affected / exposed
    8 / 107 (7.48%)
         occurrences all number
    13
    Myalgia
         subjects affected / exposed
    20 / 107 (18.69%)
         occurrences all number
    100
    Pain in extremity
         subjects affected / exposed
    11 / 107 (10.28%)
         occurrences all number
    28
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    6 / 107 (5.61%)
         occurrences all number
    7
    Nasopharyngitis
         subjects affected / exposed
    11 / 107 (10.28%)
         occurrences all number
    15
    Pharyngitis streptococcal
         subjects affected / exposed
    6 / 107 (5.61%)
         occurrences all number
    6
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    54 / 107 (50.47%)
         occurrences all number
    75

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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