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    Clinical Trial Results:
    A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in which Peginterferon Lambda-1a (BMS-914143) was Administered for the Treatment of Chronic Hepatitis C

    Summary
    EudraCT number
    		 2011-005293-31
    Trial protocol
    		 DE   AT   ES   PL   IT   GR   FI   BE   NL  
    Global end of trial date
    11 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 May 2016
    First version publication date
    26 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AI452-016
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01525810
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Bristol-Myers Squibb International Corporation, Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, clinical.trials@bms.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
    11 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to determine the durability of virologic response in subjects treated in a previous study with Lambda with or without Ribavirin and/or direct acting antiviral agents, who have Hepatitis C virus RNA less than the limit of quantitation of the assay at the completion of the required post-treatment follow-up in the previous (parent) study.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Mar 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 5
    Country: Number of subjects enrolled
    Australia: 35
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Korea, Republic of: 8
    Country: Number of subjects enrolled
    Mexico: 7
    Country: Number of subjects enrolled
    New Zealand: 3
    Country: Number of subjects enrolled
    Romania: 20
    Country: Number of subjects enrolled
    Russian Federation: 11
    Country: Number of subjects enrolled
    United States: 44
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    Spain: 9
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Austria: 1
    Country: Number of subjects enrolled
    Belgium: 4
    Country: Number of subjects enrolled
    Finland: 8
    Country: Number of subjects enrolled
    France: 22
    Country: Number of subjects enrolled
    Germany: 7
    Country: Number of subjects enrolled
    Greece: 3
    Country: Number of subjects enrolled
    Italy: 19
    Worldwide total number of subjects
    235
    EEA total number of subjects
    117
    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)
    222
    From 65 to 84 years
    13
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 64 sites in 20 countries.

    Pre-assignment
    Screening details
    		 A total of 235 eligible subjects were enrolled from 5 different studies AI452004 (526H04), AI452008, AI452017, AI452020, and AI452021. The analysis was focused on the 200 subjects who received Lambda in the parent 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
    Arm title
    		 Lambda-treated
    Arm description
    		 Subjects with Hepatitis C virus RNA <lower limit of quantitation, target detected or target not detected, who were previously treated with peginterferon lambda-1a in combination with or without ribavirin and/or other direct acting antiviral agents within 6 months after completion of follow-up in the parent study.
    Arm type
    		 Observational

    Investigational medicinal product name
    Peginterferon Lambda-1a
    Investigational medicinal product code
    BMS-914143
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were previously treated with Peginterferon Lambda-1a.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Ribasphere
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were previously treated with Peginterferon Lambda-1a in combination with or without ribavirin.

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were previously treated with Peginterferon Lambda-1a in combination with daclatasvir with or without ribavirin.

    Number of subjects in period 1 [1]
    		Lambda-treated
    Started
    200
    Completed
    0
    Not completed
    200
         Consent withdrawn by subject
    5
         Other
    4
         Lost to follow-up
    8
         Administrative reason by sponsor
    183
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 235 eligible subjects who were enrolled, the analysis was focused on the 200 subjects who received Lambda in the parent study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Lambda-treated
    Reporting group description
    		 Subjects with Hepatitis C virus RNA <lower limit of quantitation, target detected or target not detected, who were previously treated with peginterferon lambda-1a in combination with or without ribavirin and/or other direct acting antiviral agents within 6 months after completion of follow-up in the parent study.

    Reporting group values
    		 Lambda-treated Total
    Number of subjects
    		 200 200
    Age categorical
    Units: Subjects
        <65 years
    		 191 191
        >=65 years
    		 9 9
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 46.1 (20 to 75) -
    Gender categorical
    Units: Subjects
        Female
    		 89 89
        Male
    		 111 111

    End points

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    End points reporting groups
    Reporting group title
    Lambda-treated
    Reporting group description
    		 Subjects with Hepatitis C virus RNA <lower limit of quantitation, target detected or target not detected, who were previously treated with peginterferon lambda-1a in combination with or without ribavirin and/or other direct acting antiviral agents within 6 months after completion of follow-up in the parent study.

    Primary: Percentage of Hepatitis C Virus (HCV) subjects With Durable Virologic Response

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    End point title
    		 Percentage of Hepatitis C Virus (HCV) subjects With Durable Virologic Response [1]
    End point description
    Durability of virologic response was defined as the time to loss of virologic response assessed by HCV RNA levels in subjects treated in a previous study with BMS-914143 who had HCV RNA <lower limit of quantitation (LLOQ) (target detected or target not detected) at the completion of the required post-treatment follow-up in the previous (parent) study. The analysis was performed in all the subjects with HCV RNA <LLOQ, who were previously treated with peginterferon lambda-1a in combination with or without ribavirin and/or other direct acting antiviral agents within 6 months after completion of follow-up in the parent study.
    End point type
    Primary
    End point timeframe
    Day 1 and at follow-up Week 24, 48, 72, and 96 (early termination of study)
    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 summary statistics were planned for this outcome measure. 
    End point values
    		 Lambda-treated
    Number of subjects analysed
    200
    Units: Percentage of subject
        number (not applicable)
    0.5
    No statistical analyses for this end point

    Secondary: Number of Subjects With Long-Term Progression of Liver Disease

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    End point title
    		 Number of Subjects With Long-Term Progression of Liver Disease
    End point description
    Long-term progression of liver disease was measured by laboratory indicators of hepatic status and function, all-cause mortality and liver related mortality in subjects previously treated with BMS-914143 who have Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ) (target detected or target not detected) at the completion of the required post-treatment follow-up in the parent study. The analysis was performed in all the subjects with HCV RNA < LLOQ, who were previously treated with peginterferon lambda-1a in combination with or without ribavirin and/or other direct acting antiviral agents within 6 months after completion of follow-up in the parent study.
    End point type
    Secondary
    End point timeframe
    Day 1 and at follow-up Week 24, 48, 72, and 96 (early termination of study)
    End point values
    		 Lambda-treated
    Number of subjects analysed
    200
    Units: Subjects
    0
    No statistical analyses for this end point

    Secondary: Duration of Persistence of Anti-Lambda Antibodies (ADA) in Subjects Who Are Positive For Anti-Lambda Antibodies at End of Treatment in The Parent Study

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    End point title
    		 Duration of Persistence of Anti-Lambda Antibodies (ADA) in Subjects Who Are Positive For Anti-Lambda Antibodies at End of Treatment in The Parent Study
    End point description
    The duration of persistence of ADA in eligible Lambda-treated subjects who were positive at end of treatment (EOT) in the parent study was summarized using a Kaplan-Meier life table. For subjects who had ADA-positive samples and then became ADA-negative, the duration of persistence of ADA was measured from EOT in the parent study to the time of the first confirmed negative sample. For subjects who had ADA-positive samples in the parent study and did not become ADA-negative during follow-up in AI452016 study, the duration of persistence of ADA was measured from EOT in the parent study to the time of the last positive anti-Lambda antibody sample. The analysis was performed in all the subjects who were positive for anti-Lambda antibodies at the end of treatment in the parent study. Here, ‘99999’ represents not estimable data.
    End point type
    Secondary
    End point timeframe
    Day 1 and at follow-up Week 24, 48, 72, and 96 (early termination of study)
    End point values
    		 Lambda-treated
    Number of subjects analysed
    0 [2]
    Units: Weeks
        number (not applicable)
    Notes
    [2] - The study was prematurely terminated.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Day 1 and at follow-up Week 24, 48, 72, and 96 (early termination of study)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NIL
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    Lambda-treated
    Reporting group description
    		 Subjects with Hepatitis C virus RNA <lower limit of quantitation (target detected or target not detected) who were previously treated with peginterferon lambda-1a in combination with or without RBV and/or other direct acting antiviral agents within 6 months after completion of follow-up in the parent study.

    Serious adverse events
    		 Lambda-treated
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 200 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Lambda-treated
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 200 (0.00%)
    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: The study was prematurely terminated and safety data was collected if it was considered related to peginterferon lambda-1a.

    More information

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

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was terminated due to the availability of effective all-oral hepatitis C virus (HCV) treatment regimens which had changed the clinical landscape significantly, and reduced the unmet medical need in HCV.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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