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    Clinical Trial Results:
    Long-Term Follow-Up of Subjects in a Phase 1, 2, or 3 Clinical Trial in Which Boceprevir or Narlaprevir was Administered for the Treatment of Chronic Hepatitis C

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2006-006529-25
    Trial protocol
    FR   DE   ES   IT   NL   PT  
    Global end of trial date
    13 Oct 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    30 Jan 2016
    First version publication date
    30 Jan 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P05063
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00689390
    WHO universal trial number (UTN)
    -
    Other trial identifiers
    MK-3034-021: Merck Registration Number
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, 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)
    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
    13 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Study P05063 is a 3-year long-term follow-up (LTFU) study in participants previously treated with boceprevir (BOC) or narlaprevir (NAR) in a Phase 1, 2, or 3 clinical study. Participants will be followed for up to 3.5 years after the end of their participation in the treatment protocol to document maintenance of the antiviral response (for sustained responders) and to characterize the long-term safety after use of this therapeutic regimen. LTFU procedures include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid (HCV-RNA) by polymerase chain reaction (PCR) and HCV sequence analysis. No drug therapy will be administered as part of this study.
    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
    20 Feb 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 24
    Country: Number of subjects enrolled
    Belgium: 30
    Country: Number of subjects enrolled
    Brazil: 3
    Country: Number of subjects enrolled
    Canada: 91
    Country: Number of subjects enrolled
    France: 146
    Country: Number of subjects enrolled
    Germany: 103
    Country: Number of subjects enrolled
    Italy: 102
    Country: Number of subjects enrolled
    Netherlands: 13
    Country: Number of subjects enrolled
    Poland: 4
    Country: Number of subjects enrolled
    Spain: 64
    Country: Number of subjects enrolled
    United States: 1369
    Country: Number of subjects enrolled
    Portugal: 5
    Worldwide total number of subjects
    1954
    EEA total number of subjects
    467
    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)
    1871
    From 65 to 84 years
    83
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Participants were recruited from 9 boceprevir studies (P03523 [NCT00423670], P03659 [NCT00160251], P04487 [No NCT], P05101 [NCT00708500], P05216 [NCT00705432], P05411 [NCT00959699], P05514 [NCT00910624], P05685 [NCT00845065], and P06086 [NCT01023035]) and 1 narlaprevir study (P05104 [NCT00797745]).

    Pre-assignment
    Screening details
    1954 participants enrolled in this long-term follow-up (LTFU) study, with 1907 participants from 9 boceprevir studies and 47 participants from 1 narlaprevir study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Participants from Boceprevir Studies
    Arm description
    Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.
    Arm type
    Follow-up

    Investigational medicinal product name
    Boceprevir
    Investigational medicinal product code
    Other name
    VICTRELIS®
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    In previous treatment studies, boceprevir was administered as specified by the protocol. No treatment was administered in the current follow-up study (P05063, NCT00689390, 2006-006529-25).

    Investigational medicinal product name
    Peginterferon alfa-2b
    Investigational medicinal product code
    Other name
    PEG-Intron®, SCH 054031
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In previous treatment studies, peginterferon alfa-2b was administered as specified by the protocol. No treatment was administered in the current follow-up study (P05063, NCT00689390, 2006-006529-25).

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In previous treatment studies, ribavirin was administered as specified by the protocol. No treatment was administered in the current follow-up study (P05063, NCT00689390, 2006-006529-25).

    Arm title
    Participants from Narlaprevir Studies
    Arm description
    Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.
    Arm type
    Follow-up

    Investigational medicinal product name
    Narlaprevir
    Investigational medicinal product code
    Other name
    SCH 900518, MK-8515
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In previous treatment studies, narlaprevir was administered as specified by the protocol. No treatment was administered in the current follow-up study (P05063, NCT00689390, 2006-006529-25).

    Investigational medicinal product name
    Peginterferon alfa-2b
    Investigational medicinal product code
    Other name
    PEG-Intron®, SCH 054031
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    In previous treatment studies, peginterferon alfa-2b was administered as specified by the protocol. No treatment was administered in the current follow-up study (P05063, NCT00689390, 2006-006529-25).

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Rebetol®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In previous treatment studies, ribavirin was administered as specified by the protocol. No treatment was administered in the current follow-up study (P05063, NCT00689390, 2006-006529-25).

    Number of subjects in period 1
    Participants from Boceprevir Studies Participants from Narlaprevir Studies
    Started
    1907
    47
    Completed
    1481
    37
    Not completed
    426
    10
         Did Not Meet Protocol Eligibility
             1
             -
         Adverse event, serious fatal
             14
             -
         Adverse event, non-fatal
             5
             -
         Consent withdrawn by subject
             117
             3
         Non-Compliance With Protocol
             21
             -
         Administrative
             37
             -
         Withdrew Consent-Retreatment Opportunity
             52
             -
         Lost to follow-up
             179
             7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Participants from Boceprevir Studies
    Reporting group description
    Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.

    Reporting group title
    Participants from Narlaprevir Studies
    Reporting group description
    Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.

    Reporting group values
    Participants from Boceprevir Studies Participants from Narlaprevir Studies Total
    Number of subjects
    1907 47 1954
    Age categorical
    Units: Subjects
        <40 years
    173 5 178
        40 to <65 years
    1651 42 1693
        ≥65 years
    83 0 83
    Gender, Male/Female
    Units: participants
        Female
    785 19 804
        Male
    1122 28 1150

    End points

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    End points reporting groups
    Reporting group title
    Participants from Boceprevir Studies
    Reporting group description
    Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.

    Reporting group title
    Participants from Narlaprevir Studies
    Reporting group description
    Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.

    Subject analysis set title
    Previous SVR on Boceprevir + PR
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who previously received boceprevir plus PR in treatment studies and achieved sustained virologic response (SVR). No treatment was administered in the current follow-up study.

    Subject analysis set title
    Previous SVR on Narlaprevir + PR
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who previously received narlaprevir plus PR in treatment studies and achieved SVR. No treatment was administered in the current follow-up study.

    Subject analysis set title
    Previous SVR on PR Only
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who previously received PR only in boceprevir or narlaprevir treatment studies and achieved SVR. No treatment was administered in the current follow-up study

    Subject analysis set title
    Participants from Boceprevir Studies with TE-RAVs
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in the previous treatment study. No treatment was administered in the current follow-up study.

    Subject analysis set title
    Participants from Narlaprevir Studies with TE-RAVs
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.

    Primary: Number of participants with relapse during the LTFU among sustained responders from previous treatment studies with boceprevir or narlaprevir (Durability of virologic response)

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    End point title
    Number of participants with relapse during the LTFU among sustained responders from previous treatment studies with boceprevir or narlaprevir (Durability of virologic response) [1]
    End point description
    Durability of response was assessed by the number of participants who relapsed during the LTFU among those that had achieved sustained virologic response (SVR) by 24 weeks after treatment with boceprevir or narlaprevir in a previous Phase 1, 2, or 3 treatment study. In the current LTFU, participants were classified based on the last Hepatitis C Virus ribonucleic acid (HCV-RNA) result available at the time of the data cut-off date as follows: A participant was classified as a sustained virologic responder at a given time point if serum HCV-RNA was undetectable at that time point and there had not been a positive HCV-RNA since the participant was determined to have achieved SVR in the previous study. A participant was classified as a relapser if they were a sustained virologic responder in the previous treatment study and became serum HCV-RNA positive with no subsequent negative results during LTFU.
    End point type
    Primary
    End point timeframe
    From End Of Treatment (EOT) date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were reported for this endpoint. No statistical analyses were performed.
    End point values
    Previous SVR on Boceprevir + PR Previous SVR on Narlaprevir + PR Previous SVR on PR Only
    Number of subjects analysed
    1116 [2]
    40 [3]
    144 [4]
    Units: participants
    8
    0
    1
    Notes
    [2] - All sustained responders at 24 weeks post-treatment in the previous study with available data.
    [3] - All sustained responders at 24 weeks post-treatment in the previous study with available data.
    [4] - All sustained responders at 24 weeks post-treatment in the previous study with available data.
    No statistical analyses for this end point

    Primary: Kaplan-Meier exposure-adjusted relapse rate

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    End point title
    Kaplan-Meier exposure-adjusted relapse rate [5]
    End point description
    The distribution of time to relapse was summarized using Kaplan-Meier estimates for all participants who were sustained responders at 24 weeks post-treatment in the previous study. Exposure Adjusted Relapse Rate = 1000 × (number of relapses) / (Total exposure time in years). Total exposure time in years = [(total number of days from last day of treatment to the last follow-up day for all subjects who did not relapse) + (total number of days from last day of treatment to the day of relapse for those who relapsed)] / 365.25 days [for 1 year].
    End point type
    Primary
    End point timeframe
    From EOT date in the previous treatment study to the first date of a positive HCV RNA result for relapsers or the last contact date for non-relapsers in the LTFU (up to 3.5 years)
    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: Only descriptive statistics were reported for this endpoint. No statistical analyses were performed.
    End point values
    Previous SVR on Boceprevir + PR Previous SVR on Narlaprevir + PR Previous SVR on PR Only
    Number of subjects analysed
    1116 [6]
    40 [7]
    144 [8]
    Units: relapses per 1,000 person-years
        number (not applicable)
    2.3
    0
    2.2
    Notes
    [6] - All sustained responders at 24 weeks post-treatment in the previous study with available data.
    [7] - All sustained responders at 24 weeks post-treatment in the previous study with available data.
    [8] - All sustained responders at 24 weeks post-treatment in the previous study with available data.
    No statistical analyses for this end point

    Primary: Number of participants with HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A protease loci

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    End point title
    Number of participants with HCV Treatment-Emergent Resistance Associated Variants (TE-RAVs) of NS3/4A protease loci [9]
    End point description
    Plasma samples of all participants receiving at least one dose of study medication in a previous treatment protocol were evaluated by population sequencing and analyzed to detect amino acid variants in the NS3/4A protease known to be associated with reduced susceptibility to boceprevir and narlaprevir. RAVs in the NS3/4A protease gene were evaluated at 12 loci (V36, Q41, F43, T54, V55, V107, R155, A156, V158, D168, I/V170 and M175) on the basis of in vitro studies. A TE-RAV was defined as a RAV not present at baseline and that had not returned to wild type (WT) while the participant was still on treatment. The number of participants with TE-RAVS detected at the EOT in the previous treatment study are reported below, followed by those participants with TE-RAVS that returned to WT during the LTFU (among those with detected TE-RAVS). Participants could have had more than one TE-RAV. All TE-RAVs were observed in participants in the boceprevir studies.
    End point type
    Primary
    End point timeframe
    From EOT in the previous treatment study to the last available date in the LTFU (up to 3.5 years)
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were reported for this endpoint. No statistical analyses were performed.
    End point values
    Participants from Boceprevir Studies with TE-RAVs Participants from Narlaprevir Studies with TE-RAVs
    Number of subjects analysed
    308 [10]
    0 [11]
    Units: participants
        V36A TE-RAVs detected
    6
        __V36A TE-RAVs returned to WT (out of 6)
    6
        V36G TE-RAVs detected
    1
        __V36G TE-RAVs returned to WT (out of 1)
    1
        V36L TE-RAVs detected
    9
        __V36L TE-RAVs returned to WT (out of 9)
    8
        V36M TE-RAVs detected
    142
        __V36M TE-RAVs returned to WT (out of 142)
    135
        F43C TE-RAVs detected
    3
        __F43C TE-RAVs returned to WT (out of 3)
    3
        T54A TE-RAVs detected
    40
        __T54A TE-RAVs returned to WT (out of 40)
    40
        T54C TE-RAVs detected
    2
        __T54C TE-RAVs returned to WT (out of 2)
    2
        T54S TE-RAVs detected
    143
        __T54S TE-RAVs returned to WT (out of 143)
    104
        V55A TE-RAVs detected
    5
        __V55A TE-RAVs returned to WT (out of 5)
    3
        V107I TE-RAVs detected
    3
        __V107I TE-RAVs returned to WT (out of 3)
    2
        R155K TE-RAVs detected
    183
        __R155K TE-RAVs returned to WT (out of 183)
    154
        R155T TE-RAVs detected
    22
        __R155T TE-RAVs returned to WT (out of 22)
    20
        A156S TE-RAVs detected
    37
        __A156S TE-RAVs returned to WT (out of 37)
    35
        A156T TE-RAVs detected
    4
        __A156T TE-RAVs returned to WT (out of 4)
    4
        V158I TE-RAVs detected
    18
        __V158I TE-RAVs returned to WT (out of 16)
    16
        V158M TE-RAVs detected
    1
        __V158M TE-RAVs returned to WT (out of 1)
    1
        D168N TE-RAVs detected
    12
        __D168N TE-RAVs returned to WT (out of 12)
    11
        I170T TE-RAVs detected
    3
        __I170T TE-RAVs returned to WT (out of 3)
    3
        V170A TE-RAVs detected
    27
        __V170A TE-RAVs returned to WT (out of 27)
    24
        M175L TE-RAVs detected
    5
        __M175L TE-RAVs returned to WT (out of 5)
    2
    Notes
    [10] - Participants with TE-RAVs receiving ≥1 dose of study drug in a previous boceprevir clinical study.
    [11] - No participants in this treatment group had a TE-RAV.
    No statistical analyses for this end point

    Primary: Number of participants with serious adverse events (SAEs) reported during the LTFU

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    End point title
    Number of participants with serious adverse events (SAEs) reported during the LTFU [12]
    End point description
    Long-term safety was assessed based on the SAEs reported during the LTFU period. An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.
    End point type
    Primary
    End point timeframe
    From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were reported for this endpoint. No statistical analyses were performed.
    End point values
    Participants from Boceprevir Studies Participants from Narlaprevir Studies
    Number of subjects analysed
    1907 [13]
    47 [14]
    Units: participants
    136
    2
    Notes
    [13] - All enrolled participants were included in safety analyses.
    [14] - All enrolled participants were included in safety analyses.
    No statistical analyses for this end point

    Primary: Number of participants that discontinued the LTFU due to SAEs

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    End point title
    Number of participants that discontinued the LTFU due to SAEs [15]
    End point description
    An SAE was any adverse drug or biologic or device experience occurring at any dose that resulted in any of the following outcomes: death, life-threatening AE, persistent or significant disability/incapacity, required in-patient hospitalization or prolongs hospitalization, congenital anomaly or birth defect. Important medical events that did not result in any of these outcomes could still be considered SAEs if they jeopardized the participant and/or required medical/surgical intervention, based on appropriate medical judgment. Grade 4 laboratory abnormalities and out of normal range liver function tests that were not accompanied by clinical manifestations were NOT considered SAEs.
    End point type
    Primary
    End point timeframe
    From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive statistics were reported for this endpoint. No statistical analyses were performed.
    End point values
    Participants from Boceprevir Studies Participants from Narlaprevir Studies
    Number of subjects analysed
    1907 [16]
    47 [17]
    Units: participants
    19
    0
    Notes
    [16] - All enrolled participants were included in safety analyses.
    [17] - All enrolled participants were included in safety analyses.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From enrollment in the LTFU study to the last available date in the LTFU study (up to 3 years)
    Adverse event reporting additional description
    As specified in the protocol, only serious adverse events (SAEs) were collected. Other Adverse Events were not monitored and not collected, thus no participants were at risk for these events. All enrolled participants were included in safety analyses.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Participants from Narlaprevir Studies
    Reporting group description
    Participants who previously participated in treatment studies in which narlaprevir was administered were subsequently enrolled in Part 2 of the current follow-up study P05063 (NCT00689390, 2006-006529-25). Participants may have received narlaprevir or control PR in the previous treatment study. No treatment was administered in the current follow-up study.

    Reporting group title
    Participants from Boceprevir Studies
    Reporting group description
    Participants who previously participated in treatment studies in which boceprevir was administered were subsequently enrolled in Part 1 of the current follow-up study P05063 (NCT00689390, 2006-006529-25). Participants may have received boceprevir or control peginterferon plus ribavirin (PR) in theprevious treatment study. No treatment was administered in the current follow-up study.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: As specified in the protocol, long-term safety was assessed based on the SAEs reported during the long-term follow-up period. No non-serious AEs were collected or reported on this study.
    Serious adverse events
    Participants from Narlaprevir Studies Participants from Boceprevir Studies
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 47 (4.26%)
    136 / 1907 (7.13%)
         number of deaths (all causes)
    0
    14
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Aortic Aneurysm
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Arterial Occlusive Disease
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral Artery Thrombosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Coronary Artery Bypass
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Finger Amputation
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Arthroplasty
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Knee Arthroplasty
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Liver Transplant
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shoulder Arthroplasty
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgery
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Valvuloplasty Cardiac
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenoma Benign
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Cancer Stage 0
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bladder Cancer
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brain Neoplasm
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast Cancer
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diffuse Large B-Cell Lymphoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchioloalveolar Carcinoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic Cancer
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatocellular Carcinoma
         subjects affected / exposed
    0 / 47 (0.00%)
    9 / 1907 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Invasive Ductal Breast Carcinoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Neoplasm Malignant
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Adenocarcinoma Stage IV
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lymphoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metastases To Liver
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatic Carcinoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Prostate Cancer
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Cancer
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Cell Carcinoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salivary Gland Cancer
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin Cancer
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Squamous Cell Carcinoma Of Head And Neck
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thyroid Cancer
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest Pain
         subjects affected / exposed
    0 / 47 (0.00%)
    4 / 1907 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multi-Organ Failure
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Completed Suicide
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Confusional State
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterovaginal Prolapse
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle Fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol Poisoning
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Fibula Fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand Fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot Fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Injury
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rib Fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Scapula Fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stab Wound
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural Haematoma
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tibia Fracture
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity To Various Agents
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Wound Complication
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute Myocardial Infarction
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute Coronary Syndrome
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina Unstable
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Fibrillation
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 1907 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac Arrest
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac Failure Congestive
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardio-Respiratory Arrest
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiopulmonary Failure
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Coronary Artery Stenosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary Artery Disease
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 1907 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial Infarction
         subjects affected / exposed
    0 / 47 (0.00%)
    9 / 1907 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular Tachycardia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Endocardial Fibroelastosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Huntington's Disease
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Distress Syndrome
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Disorder
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Embolism
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleural Effusion
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Fibrosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Failure
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Arachnoid Cyst
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral Haemorrhage
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular Accident
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic Stroke
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tension Headache
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Corneal Oedema
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Fistula
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal Haemorrhage
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colitis Ischaemic
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 1907 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticular Perforation
         subjects affected / exposed
    1 / 47 (2.13%)
    0 / 1907 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Ulcer Haemorrhage
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Haemorrhage
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernial Eventration
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Perforation
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large Intestine Polyp
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Melaena
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal Varices Haemorrhage
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Palatal Disorder
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis Acute
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectal Haemorrhage
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varices Oesophageal
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Calculus Ureteric
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal Failure Acute
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatic Cirrhosis
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cholelithiasis
         subjects affected / exposed
    0 / 47 (0.00%)
    5 / 1907 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Cervical Spinal Stenosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar Spinal Stenosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteonecrosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 47 (0.00%)
    5 / 1907 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhabdomyolysis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Goitre
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic Ketoacidosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic Complication
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Malnutrition
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic Acidosis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute Hepatitis B
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Appendicitis Perforated
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis C
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Simplex Pneumonia
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 47 (0.00%)
    5 / 1907 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Postoperative Wound Infection
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retinitis
         subjects affected / exposed
    0 / 47 (0.00%)
    1 / 1907 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 1907 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    0 / 47 (0.00%)
    3 / 1907 (0.16%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Participants from Narlaprevir Studies Participants from Boceprevir Studies
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 1907 (0.00%)

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Dec 2009
    General amendment 1 (AM1) included changes to allow for the inclusion of participants who previously participated in boceprevir AND narlaprevir clinical studies, including Phase 1 studies and participants who received peginterferon alfa-2a as part of their therapeutic regimen. Changes included revisions to the protocol title, number of study sites, overall duration, background, rationale, primary objectives, statistical methods, and the addition of new methods for pharmacogenetic sampling and IL-28 genotype.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Jul 2014
    The study was terminated due to satisfaction of postmarketing commitments.
    -

    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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