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    Clinical Trial Results:
    A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects with Chronic HCV Infection and Underlying Hemophilia Who are Treatment Naive or are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin

    Summary
    EudraCT number
    		 2012-003463-22
    Trial protocol
    		 ES   IT   NL   FR   RO  
    Global end of trial date
    22 Jan 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Apr 2016
    First version publication date
    23 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AI452-030
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01741545
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol Myers Squibb
    Sponsor organisation address
    Chaussee de la Hulpe 185, Brussels, Belgium,
    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
    22 Jan 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Jan 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the efficacy and safety of peginterferon lambda-1a (pegIFNλ-1a referred to as Lambda) in combination with the direct-acting antiviral agent daclatasvir (DCV) and ribavirin (RBV) in hemophilia subjects with genotype (GT)-1b, -2, -3, or -4 chronic hepatitis C virus (HCV) infection.
    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
    25 Mar 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 10
    Country: Number of subjects enrolled
    France: 5
    Country: Number of subjects enrolled
    Italy: 12
    Country: Number of subjects enrolled
    Netherlands: 16
    Country: Number of subjects enrolled
    Romania: 6
    Country: Number of subjects enrolled
    Russian Federation: 12
    Country: Number of subjects enrolled
    Spain: 8
    Country: Number of subjects enrolled
    United States: 2
    Worldwide total number of subjects
    71
    EEA total number of subjects
    47
    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)
    69
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 23 centres in 8 countries.

    Pre-assignment
    Screening details
    		 A total of 71 subjects were enrolled, of which 51 subjects were randomised and treated.

    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding was performed as the study was open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort A (Treatment period)
    Arm description
    		 Subjects with HCV GT-2 or GT-3 infection (Cohort A) were to be treated with Lambda/Ribavirin/Daclatasvir. Subjects were administered daclatasvir 60 mg orally, once daily; pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    BMS-790052
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered DCV 60 mg orally twice daily.

    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
    2 ribavirin 200-mg tablets were administered twice daily for a total dose of 800 mg.

    Investigational medicinal product name
    Peginterferon lambda-1a
    Investigational medicinal product code
    BMS-914143
    Other name
    Lambda
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered 180 μg pegIFNα-2a subcutaneously.

    Arm title
    		 Cohort B (Treatment period)
    Arm description
    		 Subjects with HCV GT-1b or GT-4 infection (Cohort B) were to be treated with Lambda/Ribavirin/Daclatasvir. Subjects were administered daclatasvir 60 mg orally, once daily, pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (subjects weighing <75 kg = 1000 mg and subjects weighing ≥75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    BMS-790052-05
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects were administered DCV 60 mg orally twice daily.

    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 administered ribavirin 200-mg tablets for a total daily dose stratified on body weight (<75kg=1000mg or>=75kg=1200 mg).

    Investigational medicinal product name
    Peginterferon lambda-1a
    Investigational medicinal product code
    BMS-914143
    Other name
    Lambda
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects were administered 180 μg pegIFNα-2a subcutaneously.

    Number of subjects in period 1 [1]
    		Cohort A (Treatment period) Cohort B (Treatment period)
    Started
    12
    39
    Completed
    11
    35
    Not completed
    1
    4
         Adverse event, non-fatal
    1
    3
         Lack of efficacy
    -
    1
    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: The number of subjects reported in the baseline period are different from the worldwide number enrolled in the trial, as out of 71 subjects only 51 were randomised and received treatment in the study.
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding was performed as the study was open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort A (Follow-up period)
    Arm description
    		 Subjects with HCV GT-2 or GT-3 infection (Cohort A) were followed up for 24 weeks who received treatment with Lambda/RBV/DCV. Subjects were administered daclatasvir 60 mg orally, once daily; pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Cohort B (Follow-up period)
    Arm description
    		 Subjects with HCV GT-1b or GT-4 infection (Cohort B) were followed up for 24 weeks who received treatment with Lambda/RBV/DCV. Subjects were administered daclatasvir 60 mg orally, once daily, pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (subjects weighing <75 kg = 1000 mg and subjects weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 2
    		Cohort A (Follow-up period) Cohort B (Follow-up period)
    Started
    11
    35
    Completed
    11
    37
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    1
         Other reason
    -
    1
    Joined
    1
    4
         Rejoined for follow-up
    1
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort A (Treatment period)
    Reporting group description
    		 Subjects with HCV GT-2 or GT-3 infection (Cohort A) were to be treated with Lambda/Ribavirin/Daclatasvir. Subjects were administered daclatasvir 60 mg orally, once daily; pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively.

    Reporting group title
    Cohort B (Treatment period)
    Reporting group description
    		 Subjects with HCV GT-1b or GT-4 infection (Cohort B) were to be treated with Lambda/Ribavirin/Daclatasvir. Subjects were administered daclatasvir 60 mg orally, once daily, pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (subjects weighing <75 kg = 1000 mg and subjects weighing ≥75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively.

    Reporting group values
    		 Cohort A (Treatment period) Cohort B (Treatment period) Total
    Number of subjects
    		 12 39 51
    Age categorical
    Units: Subjects
        21 - <65 years
    		 12 38 50
        >=65 years
    		 0 1 1
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.8 ± 9.94 45.2 ± 12.04 -
    Gender categorical
    Units: Subjects
        Male
    		 12 39 51
    HCV Genotype
    Units: Subjects
        Genotype 1A
    		 0 0 0
        Genotype 1B
    		 0 39 39
        Genotype 2
    		 2 0 2
        Genotype 3
    		 10 0 10
        Genotype 4
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Cohort A (Treatment period)
    Reporting group description
    		 Subjects with HCV GT-2 or GT-3 infection (Cohort A) were to be treated with Lambda/Ribavirin/Daclatasvir. Subjects were administered daclatasvir 60 mg orally, once daily; pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively.

    Reporting group title
    Cohort B (Treatment period)
    Reporting group description
    		 Subjects with HCV GT-1b or GT-4 infection (Cohort B) were to be treated with Lambda/Ribavirin/Daclatasvir. Subjects were administered daclatasvir 60 mg orally, once daily, pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (subjects weighing <75 kg = 1000 mg and subjects weighing ≥75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively.
    Reporting group title
    Cohort A (Follow-up period)
    Reporting group description
    		 Subjects with HCV GT-2 or GT-3 infection (Cohort A) were followed up for 24 weeks who received treatment with Lambda/RBV/DCV. Subjects were administered daclatasvir 60 mg orally, once daily; pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively.

    Reporting group title
    Cohort B (Follow-up period)
    Reporting group description
    		 Subjects with HCV GT-1b or GT-4 infection (Cohort B) were followed up for 24 weeks who received treatment with Lambda/RBV/DCV. Subjects were administered daclatasvir 60 mg orally, once daily, pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (subjects weighing <75 kg = 1000 mg and subjects weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively.

    Subject analysis set title
    Cohort A (Treatment and Follow-up periods)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects with HCV GT-2 or GT-3 infection (Cohort A) were followed up for 24 weeks who received treatment with Lambda/RBV/DCV. During treatment period subjects received daclatasvir 60 mg orally, once daily; pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, orally, twice daily (a total 800 mg per day) for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively.

    Subject analysis set title
    Cohort B (Treatment and Follow-up periods)
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects with HCV GT-1b or GT-4 infection (Cohort B) were followed up for 24 weeks who received treatment with Lambda/RBV/DCV. During treatment period subjects received daclatasvir 60 mg orally, once daily, pegIFNλ-1a 180 µg subcutaneous injection, once weekly and ribavirin tablets, twice daily, orally, based on weight (subjects weighing <75 kg = 1000 mg and subjects weighing >=75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively.

    Primary: Percentage of Subjects Who Achieve Sustained Virologic Response (SVR12) at Follow-Up Week 12

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    End point title
    		 Percentage of Subjects Who Achieve Sustained Virologic Response (SVR12) at Follow-Up Week 12 [1]
    End point description
    SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. The analysis was performed in modified intent to treat population defined as subjects meeting the response criteria over all treated subjects.
    End point type
    Primary
    End point timeframe
    Follow-up Week 12
    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 was planned for this outcome measure.
    End point values
    		 Cohort A (Follow-up period) Cohort B (Follow-up period)
    Number of subjects analysed
    12
    39
    Units: Percentage of subjects
        number (confidence interval 95%)
    91.7 (61.5 to 99.8)
    89.7 (75.8 to 97.1)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Rapid Virologic Response (RVR)

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    End point title
    		 Percentage of Subjects With Rapid Virologic Response (RVR)
    End point description
    RVR was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 4. The analysis was performed in modified intent to treat population defined as subjects meeting the response criteria over all treated subjects.
    End point type
    Secondary
    End point timeframe
    Week 4
    End point values
    		 Cohort A (Treatment period) Cohort B (Treatment period)
    Number of subjects analysed
    12
    39
    Units: Percentage of subjects
        number (confidence interval 95%)
    91.7 (61.5 to 99.8)
    76.9 (60.7 to 88.9)
    No statistical analyses for this end point

    Secondary: Percentage of subjects With Complete Early Virologic Response (cEVR)

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    End point title
    		 Percentage of subjects With Complete Early Virologic Response (cEVR)
    End point description
    cEVR was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at Week 12. The analysis was performed in modified intent to treat population defined as subjects meeting the response criteria over all treated subjects.
    End point type
    Secondary
    End point timeframe
    Week 12
    End point values
    		 Cohort A (Treatment period) Cohort B (Treatment period)
    Number of subjects analysed
    12
    39
    Units: Percentage of subjects
        number (confidence interval 95%)
    91.7 (61.5 to 99.8)
    92.3 (79.1 to 98.4)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With End of the Treatment Response (EOTR)

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    End point title
    		 Percentage of Subjects With End of the Treatment Response (EOTR)
    End point description
    EOTR was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target not detected at end of treatment. The analysis was performed in modified intent to treat population defined as subjects meeting the response criteria over all treated subjects.
    End point type
    Secondary
    End point timeframe
    End of the treatment (Week 24)
    End point values
    		 Cohort A (Treatment period) Cohort B (Treatment period)
    Number of subjects analysed
    12
    39
    Units: Percentage of subjects
        number (confidence interval 95%)
    100 (73.5 to 100)
    100 (91 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24)

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24)
    End point description
    SVR24 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24. The analysis was performed in modified intent to treat population defined as subjects meeting the response criteria over all treated subjects.
    End point type
    Secondary
    End point timeframe
    Follow-up Week 24 Follow-up
    End point values
    		 Cohort A (Follow-up period) Cohort B (Follow-up period)
    Number of subjects analysed
    12
    39
    Units: Percentage of subjects
        number (confidence interval 95%)
    66.7 (34.9 to 90.1)
    30.8 (17 to 47.6)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Treatment-Emergent Cytopenic Abnormalities On-Treatment

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    End point title
    		 Percentage of Subjects With Treatment-Emergent Cytopenic Abnormalities On-Treatment
    End point description
    Cytopenic abnormalities were defined as anemia as defined by Hb <10 g/dL, and/or neutropenia as defined by ANC <750 mm^3, and/or thrombocytopenia as defined by platelets <50,000 mm^3. The analysis was performed in modified intent to treat population defined as subjects meeting the response criteria over all treated subjects.
    End point type
    Secondary
    End point timeframe
    After Day 1 to end of treatment
    End point values
    		 Cohort A (Treatment period) Cohort B (Treatment period)
    Number of subjects analysed
    12
    39
    Units: Percentage of subjects
        number (confidence interval 95%)
    0 (0 to 26.5)
    0 (0 to 9)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment

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    End point title
    		 Percentage of Subjects With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment
    End point description
    Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain. The analysis was performed in modified intent to treat population defined as subjects meeting the response criteria over all treated subjects.
    End point type
    Secondary
    End point timeframe
    Day 1 to end of treatment
    End point values
    		 Cohort A (Treatment period) Cohort B (Treatment period)
    Number of subjects analysed
    12
    39
    Units: Percentage of subjects
    number (confidence interval 95%)
        Flu-like symptoms
    8.3 (0.2 to 38.5)
    12.8 (4.3 to 27.4)
        Musculoskeletal symptoms
    0 (0 to 26.5)
    15.4 (5.9 to 30.5)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Who Died

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    End point title
    		 Percentage of Subjects With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Who Died
    End point description
    AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug. The analysis was performed on all treated subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
    End point values
    		 Cohort A (Treatment and Follow-up periods) Cohort B (Treatment and Follow-up periods)
    Number of subjects analysed
    12
    39
    Units: Subjects
        AEs on treatment
    10
    38
        SAEs
    0
    4
        Death
    0
    0
        AE leading to discontinuation
    1
    3
        Dose reduction - Lambda
    0
    1
        Dose reduction - RBV
    0
    2
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities

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    End point title
    		 Number of Subjects With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
    End point description
    Laboratory abnormalities were determined and graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): >2.0*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : >5*ULN; Aspartate aminotransferase (AST): >5*ULN; Prothrombin Time (PT): >1.50*ULN; Bilirubin (Total): >2.5*ULN; Triglycerides (fasting): >750 mg/dL. The analysis was performed on all treated subjects.
    End point type
    Secondary
    End point timeframe
    After Day 1 to end of treatment
    End point values
    		 Cohort A (Treatment period) Cohort B (Treatment period)
    Number of subjects analysed
    12
    39
    Units: Subjects
        INR
    0
    1
        ALT
    2
    1
        AST
    0
    2
        PT
    0
    1
        Bilirubin
    2
    7
        Triglycerides
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    After Day 1 to end of treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Cohort A (Treatment period)
    Reporting group description
    		 Subjects with HCV GT-2 or GT-3 infection (Cohort A) were to be treated with Lambda/RBV/DCV. Subjects were administered with once daily DCV 60 mg orally, once weekly pegIFNλ-1a 180 µg SC injection and twice daily RBV a total 800 mg per day for 12 weeks treatment, 12 weeks and a maximum of 12 weeks, respectively.

    Reporting group title
    Cohort B (Treatment period)
    Reporting group description
    		 Subjects with HCV GT-1b or GT-4 infection (Cohort B) were to be treated with Lambda/RBV/DCV. Subjects were administered with once daily DCV 60 mg orally, once weekly pegIFNλ-1a 180 µg SC injection and twice daily RBV based on weight (subjects weighing <75 kg = 1000 mg and subjects weighing ≥75 kg = 1200 mg per day) for 12 weeks treatment, 24 weeks and a maximum of 24 weeks, respectively.

    Serious adverse events
    		 Cohort A (Treatment period) Cohort B (Treatment period)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 39 (5.13%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Hepatobiliary disorders
    Hepatitis acute
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort A (Treatment period) Cohort B (Treatment period)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 12 (83.33%)
    36 / 39 (92.31%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    4
    Haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 12 (0.00%)
    12 / 39 (30.77%)
         occurrences all number
    0
    13
    Fatigue
         subjects affected / exposed
    3 / 12 (25.00%)
    9 / 39 (23.08%)
         occurrences all number
    3
    9
    Pyrexia
         subjects affected / exposed
    1 / 12 (8.33%)
    5 / 39 (12.82%)
         occurrences all number
    1
    6
    Influenza like illness
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    4
    Dyspnoea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    3 / 12 (25.00%)
    13 / 39 (33.33%)
         occurrences all number
    3
    16
    Sleep disorder
         subjects affected / exposed
    1 / 12 (8.33%)
    5 / 39 (12.82%)
         occurrences all number
    1
    5
    Affect lability
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Anger
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Anxiety
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Irritability
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 39 (5.13%)
         occurrences all number
    2
    2
    Depression
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Initial insomnia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Blood bilirubin increased
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 39 (5.13%)
         occurrences all number
    2
    2
    Weight decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 39 (5.13%)
         occurrences all number
    1
    2
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 39 (2.56%)
         occurrences all number
    2
    1
    Lipase increased
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 39 (2.56%)
         occurrences all number
    1
    3
    Blood bicarbonate decreased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 12 (8.33%)
    7 / 39 (17.95%)
         occurrences all number
    1
    14
    Dizziness
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    3
    Disturbance in attention
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 12 (16.67%)
    8 / 39 (20.51%)
         occurrences all number
    3
    9
    Diarrhoea
         subjects affected / exposed
    0 / 12 (0.00%)
    6 / 39 (15.38%)
         occurrences all number
    0
    6
    Abdominal pain
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    3
    Dry mouth
         subjects affected / exposed
    0 / 12 (0.00%)
    3 / 39 (7.69%)
         occurrences all number
    0
    3
    Dyspepsia
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 39 (5.13%)
         occurrences all number
    1
    2
    Rectal haemorrhage
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Vomiting
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    1 / 12 (8.33%)
    7 / 39 (17.95%)
         occurrences all number
    1
    7
    Dry skin
         subjects affected / exposed
    0 / 12 (0.00%)
    4 / 39 (10.26%)
         occurrences all number
    0
    5
    Rash
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 39 (2.56%)
         occurrences all number
    1
    1
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    2 / 12 (16.67%)
    4 / 39 (10.26%)
         occurrences all number
    2
    4
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 12 (0.00%)
    4 / 39 (10.26%)
         occurrences all number
    0
    4
    Haemarthrosis
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Myalgia
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    2 / 12 (16.67%)
    5 / 39 (12.82%)
         occurrences all number
    2
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2012
    Removed GT-1a subjects from being eligible to participate in the trial.
    19 Jul 2013
    Updated to exclude cirrhotic subjects who have evidence of preexisting portal hypertension.
    24 Oct 2013
    Updated to include severe hemophiliacs, change in Medical Monitor.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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