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    Clinical Trial Results:
    A phase IV open-label multicentre, international trial of response guided treatment with directly observed pegylated interferon alfa 2b and self-administered ribavirin for patients with chronic HCV genotype 2 or 3 infection and ongoing injection drug use.

    Summary
    EudraCT number
    		 2010-024557-36
    Trial protocol
    		 GB   BE   DE  
    Global end of trial date
    20 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Oct 2019
    First version publication date
    16 Oct 2019
    Other versions
    Summary report(s)
    		 Primary paper ACTIVATE study 2017

    Trial information

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    Trial identification
    Sponsor protocol code
    VHCRP1007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01364090
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of New South Wales, The Kirby Institute
    Sponsor organisation address
    Wallace Wurth building, Sydney, Australia, 2052 NSW
    Public contact
    Pip Marks, University of New South Wales, The Kirby Institute, +61 0293850886, pmarks@kirby.unsw.edu.au
    Scientific contact
    Professor Gregory Dore, University of New South Wales, The Kirby Institute, +61 0293850898, gdore@kirby.unsw.edu.au
    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
    20 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following directly observed PEG-IFN alfa-2b (1.5 μg/kg weekly, to a maximum of 150 μg/week) in combination with self-administered ribavirin (800-1400 milligrams daily) for 12 weeks in participants with non-quantifiable (<15 IU/ml detected and <15 IU/ml undetected) HCV RNA or undetectable HCV RNA on qualitative assay at week 4 of therapy, and for 24 weeks in participants with quantifiable (≥15 IU/ml) HCV RNA or detectable HCV RNA on qualitative assay at week 4 of therapy. In this feasibility study, the primary endpoint measurement of efficacy of treatment will be SVR12.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    01 Sep 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Scientific research
    Long term follow-up duration
    		 30 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 40
    Country: Number of subjects enrolled
    Canada: 15
    Country: Number of subjects enrolled
    Switzerland: 9
    Country: Number of subjects enrolled
    Norway: 12
    Country: Number of subjects enrolled
    United Kingdom: 7
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Germany: 4
    Worldwide total number of subjects
    93
    EEA total number of subjects
    29
    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)
    93
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 From May 11, 2012, to September 30, 2014, participants were enrolled at 17 sites in Australia (n = 5), Belgium (n = 2), Canada (n = 3), Germany (n = 1), Norway (n = 2), Switzerland (n = 3) and the United Kingdom (n = 1). The last participant visit was July 15, 2015.

    Pre-assignment
    Screening details
    		 Participants had to be >18 years of age, have chronic HCV genotype 2 or 3 infection, be HCV treatment-naïve, and have reported recent injecting drug use. 119 patients were screened and 93 were enrolled. Among the 26 patients who were excluded, 7 refused to participate, 11 were ineligible and 8 were excluded for other reasons

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

    Arms
    Arm title
    		 all subjects
    Arm description
    		 -
    Arm type
    		 baseline

    Investigational medicinal product name
    PEG-IFN & Ribavirin
    Investigational medicinal product code
    PEF-IFN, RBV
    Other name
    Pharmaceutical forms
    Tablet, Suspension for suspension for injection
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    pegylated interferon alfa-2b (PEG-IFN weekly, 1.5 mg/kg/week) and self-administered ribavirin (RBV, 800–1400 mg daily, weight-based)

    Number of subjects in period 1
    		all subjects
    Started
    93
    Completed
    93
    Period 2
    Period 2 title
    Completed trial
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Shortened therapy
    Arm description
    		 Participants with an RVR [defined as non-quantifiable HCV RNA (<15 IU/ml detected and <15 IU/ml undetected) or undetectable HCV RNA on qualitative assay at week 4] received 12 weeks of therapy (shortened duration).
    Arm type
    		 Experimental

    Investigational medicinal product name
    PEG-IFN & Ribavirin
    Investigational medicinal product code
    PEF-IFN, RBV
    Other name
    Pharmaceutical forms
    Tablet, Suspension for suspension for injection
    Routes of administration
    Oral use, Intravenous use
    Dosage and administration details
    pegylated interferon alfa-2b (PEG-IFN weekly, 1.5 mg/kg/week) and self-administered ribavirin (RBV, 800–1400 mg daily, weight-based)

    Arm title
    		 Standard therapy
    Arm description
    		 Participants without an RVR [defined as quantifiable HCV RNA (15 IU/ml) or detectable HCV RNA on qualitative assay at week 4] received 24 weeks of therapy (standard duration).
    Arm type
    		 Standard arm

    Investigational medicinal product name
    PEG-IFN & Ribavirin
    Investigational medicinal product code
    PEF-IFN, RBV
    Other name
    Pharmaceutical forms
    Suspension for suspension for injection, Tablet
    Routes of administration
    Intravenous use, Oral use
    Dosage and administration details
    pegylated interferon alfa-2b (PEG-IFN weekly, 1.5 mg/kg/week) and self-administered ribavirin (RBV, 800–1400 mg daily, weight-based)

    Number of subjects in period 2 [1]
    		Shortened therapy Standard therapy
    Started
    61
    26
    Week 4
    61
    26
    ETR
    59
    12
    SVR12
    51
    10
    Completed
    51
    10
    Not completed
    10
    16
         Medical contraindication
    1
    2
         Consent withdrawn by subject
    2
    3
         Relapse
    3
    2
         Adverse event, non-fatal
    1
    4
         Lost to follow-up
    3
    4
         Lack of efficacy
    -
    1
    Notes
    [1] - 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: The period 2 starts at Week 4 where subjects are allocated to an arm (standard or shortened therapy). 4 subjects withdrew (for various reasons) the study between baseline (period 1) and the start of period 2 (starting at Week 4).

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    baseline
    Reporting group description
    		 -

    Reporting group values
    		 baseline Total
    Number of subjects
    		 93 93
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
        Adults <64
    		 0
    Age continuous
    Age was captured in the electronic case report form for all 93 enrolled participants.
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 41 (35 to 49) -
    Gender categorical
    Gender was captured in the electronic case report form for all 93 enrolled participants.
    Units: Subjects
        Female
    		 16 16
        Male
    		 77 77
        Not recorded
    		 0 0
    Ethnicity
    Ethnicity was captured in the electronic case report form for all 93 enrolled participants.
    Units: Subjects
        Caucasian
    		 84 84
        Non caucasian
    		 9 9
        Not recorded
    		 0 0
    Education
    Education was captured in the electronic case report form for all 93 enrolled participants.
    Units: Subjects
        High school or higher education
    		 40 40
        No high school or higher education
    		 53 53
        Not recorded
    		 0 0
    Housing
    Housing was captured in the electronic case report form for all 93 enrolled participants.
    Units: Subjects
        Stable housing
    		 71 71
        Non stable housing
    		 22 22
        Not recorded
    		 0 0
    Imprisonment
    Imprisonment was captured in the electronic case report form for all 93 enrolled participants.
    Units: Subjects
        History of imprisonment
    		 66 66
        No history of imprisonment
    		 27 27
        Not recorded
    		 0 0
    Drug use in the last 6 months
    Drug use in the last 6 months was captured in the case report form for all 93 participants.
    Units: Subjects
        injecting
    		 77 77
        non-injecting
    		 16 16
        Not recorded
    		 0 0
    Drug use in the last month
    Drug use in the last month was captured in the case report form for all 93 participants.
    Units: Subjects
        injecting
    		 62 62
        non-injecting
    		 31 31
        Not recorded
    		 0 0
    History of any injecting drug use (IDU)
    History of any injecting drug use was captured in the case report form for all 93 participants.
    Units: Subjects
        History of IDU
    		 89 89
        No history of IDU
    		 4 4
        Not recorded
    		 0 0
    Injecting drug use frequency in the last month
    Injecting drug use frequency in the last month was captured in the case report form for all 93 participants.
    Units: Subjects
        Never
    		 38 38
        > daily
    		 15 15
        < daily
    		 40 40
        Not recorded
    		 0 0
    Opioid substitution treatment (OST)
    Opioid substitution treatment was captured in the case report form for all 93 participants.
    Units: Subjects
        OST ever
    		 82 82
        No history of OST
    		 11 11
        Not recorded
    		 0 0
    HCV genotype
    HCV genotype was captured in the case report form for all 93 participants.
    Units: Subjects
        1a
    		 1 1
        2b
    		 7 7
        2a
    		 2 2
        3a
    		 83 83
        Not recorded
    		 0 0
    Stage of liver disease
    Stage of liver disease was captured in the case report form for all 93 participants.
    Units: Subjects
        No or mild fibrosis (F0-F1)
    		 63 63
        Moderate or advanced fibrosis (F2-F3)
    		 20 20
        Cirrhosis (F4)
    		 10 10
        Not recorded
    		 0 0
    Mean BMI
    Mean BMI was captured in the electronic case report form for all 93 enrolled participants.
    Units: kg/m2
        median (standard deviation)
    		 ± -
    Age of first injecting drug use
    History of any injecting drug use was captured in the case report form for 92 participants (1 missing value).
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 -
    Mean HCV RNA
    Mean HCV RNA was captured in the case report form for all 93 participants.
    Units: log IU/mL
        median (inter-quartile range (Q1-Q3))
    		 -
    Subject analysis sets

    Subject analysis set title
    ITT analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who have received at least one dose of PEG-IFN

    Subject analysis sets values
    		 ITT analysis
    Number of subjects
    93
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
        Adults <64
    Age continuous
    Age was captured in the electronic case report form for all 93 enrolled participants.
    Units: years
        median (inter-quartile range (Q1-Q3))
    41 (35 to 49)
    Gender categorical
    Gender was captured in the electronic case report form for all 93 enrolled participants.
    Units: Subjects
        Female
    16
        Male
    77
        Not recorded
    0
    Ethnicity
    Ethnicity was captured in the electronic case report form for all 93 enrolled participants.
    Units: Subjects
        Caucasian
    84
        Non caucasian
    9
        Not recorded
    0
    Education
    Education was captured in the electronic case report form for all 93 enrolled participants.
    Units: Subjects
        High school or higher education
    40
        No high school or higher education
    53
        Not recorded
    0
    Housing
    Housing was captured in the electronic case report form for all 93 enrolled participants.
    Units: Subjects
        Stable housing
    71
        Non stable housing
    22
        Not recorded
    0
    Imprisonment
    Imprisonment was captured in the electronic case report form for all 93 enrolled participants.
    Units: Subjects
        History of imprisonment
    66
        No history of imprisonment
    27
        Not recorded
    0
    Drug use in the last 6 months
    Drug use in the last 6 months was captured in the case report form for all 93 participants.
    Units: Subjects
        injecting
    77
        non-injecting
    16
        Not recorded
    0
    Drug use in the last month
    Drug use in the last month was captured in the case report form for all 93 participants.
    Units: Subjects
        injecting
    62
        non-injecting
    31
        Not recorded
    0
    History of any injecting drug use (IDU)
    History of any injecting drug use was captured in the case report form for all 93 participants.
    Units: Subjects
        History of IDU
    89
        No history of IDU
    4
        Not recorded
    0
    Injecting drug use frequency in the last month
    Injecting drug use frequency in the last month was captured in the case report form for all 93 participants.
    Units: Subjects
        Never
    38
        > daily
    15
        < daily
    40
        Not recorded
    0
    Opioid substitution treatment (OST)
    Opioid substitution treatment was captured in the case report form for all 93 participants.
    Units: Subjects
        OST ever
    82
        No history of OST
    11
        Not recorded
    0
    HCV genotype
    HCV genotype was captured in the case report form for all 93 participants.
    Units: Subjects
        1a
    1
        2b
    7
        2a
    2
        3a
    83
        Not recorded
    0
    Stage of liver disease
    Stage of liver disease was captured in the case report form for all 93 participants.
    Units: Subjects
        No or mild fibrosis (F0-F1)
    63
        Moderate or advanced fibrosis (F2-F3)
    20
        Cirrhosis (F4)
    10
        Not recorded
    0
    Mean BMI
    Mean BMI was captured in the electronic case report form for all 93 enrolled participants.
    Units: kg/m2
        median (standard deviation)
    26 ± 5.4
    Age of first injecting drug use
    History of any injecting drug use was captured in the case report form for 92 participants (1 missing value).
    Units: years
        median (inter-quartile range (Q1-Q3))
    20 (16 to 26)
    Mean HCV RNA
    Mean HCV RNA was captured in the case report form for all 93 participants.
    Units: log IU/mL
        median (inter-quartile range (Q1-Q3))
    6.08 (5.63 to 6.70)

    End points

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    End points reporting groups
    Reporting group title
    all subjects
    Reporting group description
    		 -
    Reporting group title
    Shortened therapy
    Reporting group description
    		 Participants with an RVR [defined as non-quantifiable HCV RNA (<15 IU/ml detected and <15 IU/ml undetected) or undetectable HCV RNA on qualitative assay at week 4] received 12 weeks of therapy (shortened duration).

    Reporting group title
    Standard therapy
    Reporting group description
    		 Participants without an RVR [defined as quantifiable HCV RNA (15 IU/ml) or detectable HCV RNA on qualitative assay at week 4] received 24 weeks of therapy (standard duration).

    Subject analysis set title
    ITT analysis
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All subjects who have received at least one dose of PEG-IFN

    Primary: Sustained virologic response at 12 weeks post-treatment (SVR12)

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    End point title
    		 Sustained virologic response at 12 weeks post-treatment (SVR12)
    End point description
    The aim of this endpoint was to compare the percentage of patients with an SVR among those who receive HCV therapy for 12 weeks (non-quantifiable HCV RNA [i.e. <15 IU/ml detected and <15 IU/ml undetected] or undetectable HCV RNA on qualitative assay at week 4) and 24 weeks (quantifiable HCV RNA [i.e. ≥15 IU/ml] or detectable HCV RNA on qualitative assay at week 4)
    End point type
    Primary
    End point timeframe
    HCV RNA results were collected 12 weeks after the end of treatment of study participants.
    End point values
    		 Shortened therapy Standard therapy
    Number of subjects analysed
    61
    26
    Units: subjects
    number (not applicable)
        HCV RNA undetectable
    51
    10
    Statistical analysis title
    		 Primary endpoint
    Statistical analysis description
    A total of 100 subjects is planned for enrolment and evaluation as the intention-to-treat population. This study population was chosen to provide a reasonably precise measure of treatment response and evaluate the feasibility of recruitment of active IDUs through the multinational network. Assuming an overall SVR of 70%, the 95% confidence intervals around this estimate will be 60% to 79%.
    Comparison groups
    Shortened therapy v Standard therapy
    Number of subjects included in analysis
    87
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 60
         upper limit
    		 79

    Secondary: End of treatment (ETR)

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    End point title
    		 End of treatment (ETR)
    End point description
    The aim of this endpoint was to compare the percentage of patients with ETR among those who receive HCV therapy for 12 weeks (non-quantifiable HCV RNA [i.e. <15 IU/ml detected and <15 IU/ml undetected] or undetectable HCV RNA on qualitative assay at week 4) and 24 weeks (quantifiable HCV RNA [i.e. ≥15 IU/ml] or detectable HCV RNA on qualitative assay at week 4)
    End point type
    Secondary
    End point timeframe
    HCV RNA results were collected at the end of treatment of study participants (either 12 or 24 weeks depending on the arm of treatment).
    End point values
    		 Shortened therapy Standard therapy
    Number of subjects analysed
    61
    26
    Units: Subjects
    number (not applicable)
        HCV RNA undetectable at ETR
    58
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All subjects were monitored for the occurrence of Adverse Events from screening through to 24 weeks following cessation of therapy.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Overall
    Reporting group description
    		 All patients enrolled in the study

    Reporting group title
    Standard therapy
    Reporting group description
    		 Subjects in the standard therapy arm

    Reporting group title
    Shortened therapy
    Reporting group description
    		 Subjects in the shortened therapy arm

    Serious adverse events
    		 Overall Standard therapy Shortened therapy
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 93 (11.83%)
    4 / 26 (15.38%)
    6 / 61 (9.84%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Pseudo-aneurysm
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 26 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Non-sustained ventricular tachycardia
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 26 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Accident automobile
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 26 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Nausea and vomiting
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 26 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Emesis
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 26 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Small bowel obstruction
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 26 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Abscess
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 26 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    1 / 93 (1.08%)
    1 / 26 (3.85%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug dependance
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 26 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Product issues
    Drug intoxication
         subjects affected / exposed
    3 / 93 (3.23%)
    1 / 26 (3.85%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Unspecified drug dependence
         subjects affected / exposed
    1 / 93 (1.08%)
    0 / 26 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug overdose
         subjects affected / exposed
    3 / 93 (3.23%)
    1 / 26 (3.85%)
    2 / 61 (3.28%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 93 (1.08%)
    1 / 26 (3.85%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall Standard therapy Shortened therapy
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    91 / 93 (97.85%)
    26 / 26 (100.00%)
    60 / 61 (98.36%)
    Injury, poisoning and procedural complications
    Injection site erythema
         subjects affected / exposed
    17 / 93 (18.28%)
    4 / 26 (15.38%)
    8 / 61 (13.11%)
         occurrences all number
    17
    4
    8
    Nervous system disorders
    Headache
         subjects affected / exposed
    35 / 93 (37.63%)
    14 / 26 (53.85%)
    21 / 61 (34.43%)
         occurrences all number
    35
    14
    21
    Insomnia
         subjects affected / exposed
    19 / 93 (20.43%)
    4 / 26 (15.38%)
    15 / 61 (24.59%)
         occurrences all number
    19
    4
    15
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    48 / 93 (51.61%)
    14 / 26 (53.85%)
    33 / 61 (54.10%)
         occurrences all number
    48
    14
    33
    Influenza like illness
         subjects affected / exposed
    36 / 93 (38.71%)
    13 / 26 (50.00%)
    19 / 61 (31.15%)
         occurrences all number
    36
    13
    19
    Blood and lymphatic system disorders
    Anemia
         subjects affected / exposed
    17 / 93 (18.28%)
    5 / 26 (19.23%)
    12 / 61 (19.67%)
         occurrences all number
    17
    5
    12
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    33 / 93 (35.48%)
    5 / 26 (19.23%)
    26 / 61 (42.62%)
         occurrences all number
    33
    5
    26
    Vomiting
         subjects affected / exposed
    18 / 93 (19.35%)
    5 / 26 (19.23%)
    11 / 61 (18.03%)
         occurrences all number
    18
    5
    11
    Skin and subcutaneous tissue disorders
    Dry skin
         subjects affected / exposed
    17 / 93 (18.28%)
    5 / 26 (19.23%)
    12 / 61 (19.67%)
         occurrences all number
    17
    5
    12
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    26 / 93 (27.96%)
    7 / 26 (26.92%)
    18 / 61 (29.51%)
         occurrences all number
    26
    7
    18
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    25 / 93 (26.88%)
    6 / 26 (23.08%)
    19 / 61 (31.15%)
         occurrences all number
    25
    6
    19

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Jun 2013
    Protocol amended to v5 dated 24-Jun-13. Changes were: - inclusion of patients receiving opiates substitution therapy - primary variable to assess efficacy changed to SVR12 - definition of active injecting drug use changed to 24 weeks prior to consent - definitions of detectable and undetectable HCV RNA clarified - PEG-IFN administration: Week 6 visit inserted
    09 Dec 2014
    Protocol v5 updated to protocol v6 dated 9-Dec-14. Changes were: - Addition of a follow-up 1 visit (long term follow-up) from 24 to 132 weeks post-treatment

    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.
    The study population may not be generalizable to all populations of PWID and may reflect a population more engaged in health services.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28624134
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    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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