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    Clinical Trial Results:
    A DOUBLE-BLINDED, RANDOMIZED CONTROL STUDY EVALUATING THE EFFICACY AND SAFETY OF PEGINTERFERON LAMBDA-1a COMPARED TO PEGINTERFERON ALFA-2a, EACH IN COMBINATION WITH RIBAVARIN, IN THE TREATMENT OF NAIVE GENOTYPE 1 CHRONIC HEPATITIS C SUBJECTS

    Summary
    EudraCT number
    		 2012-003508-11
    Trial protocol
    		 CZ   PL  
    Global end of trial date
    18 Sep 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Dec 2018
    First version publication date
    29 Dec 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    AI452033
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, clinical.trails@bms.com
    Scientific contact
    Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trails@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
    18 Sep 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Evaluation of the safety of 48 weeks of treatment with Lambda/RBV compared to Alfa-2a/RBV in reducing an aggregate of treatment emergent cytopenic abnormalities (anemia as defined by hemoglobin [Hb] <10 g/dL, and/or neutropenia as defined by ANC <750 mm3 and/or thrombocytopenia as defined by platelets <50,000 mm3)
    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 Apr 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
    Korea, Republic of: 19
    Country: Number of subjects enrolled
    Mexico: 20
    Worldwide total number of subjects
    39
    EEA total number of subjects
    0
    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)
    36
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 76 subjects were enrolled; 40 subjects were randomized and received treatment; 36 subjects were not randomized due to administrative reason by sponsor (20), subject no longer met study criteria (13), lost to follow-up (1), subject withdrew consent (1), and other reason (1).

    Period 1
    Period 1 title
    Treatment Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Peginterferon Lambda-1a + Ribavirin
    Arm description
    		 Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribavarin
    Investigational medicinal product code
    Other name
    Ribasphere; RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    oral tablets administered twice a day for a total daily dose of 1000-1200 mg, for a maximum of 48 weeks.

    Investigational medicinal product name
    Peginterferon Lambda-1a
    Investigational medicinal product code
    Other name
    Lambda, BMS-914143
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 microgram subcutaneous (SC) injection once weekly

    Arm title
    		 Peginterferon alfa-2a + Ribavirin
    Arm description
    		 Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Peginterferon alfa-2a
    Investigational medicinal product code
    Other name
    Alfa-2a
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 microgram SC injection once weekly, for a maximum of 48 weeks

    Number of subjects in period 1
    		Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin
    Started
    26
    13
    Completed
    20
    7
    Not completed
    6
    6
         Adverse event, non-fatal
    3
    3
         Lack of efficacy
    3
    3
    Period 2
    Period 2 title
    Follow-Up Period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Peginterferon Lambda-1a + Ribavirin
    Arm description
    		 Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ribavarin
    Investigational medicinal product code
    Other name
    Ribasphere; RBV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    oral tablets administered twice a day for a total daily dose of 1000-1200 mg, for a maximum of 48 weeks.

    Investigational medicinal product name
    Peginterferon Lambda-1a
    Investigational medicinal product code
    Other name
    Lambda, BMS-914143
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 microgram subcutaneous (SC) injection once weekly

    Arm title
    		 Peginterferon alfa-2a + Ribavirin
    Arm description
    		 Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Peginterferon alfa-2a
    Investigational medicinal product code
    Other name
    Alfa-2a
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    180 microgram SC injection once weekly, for a maximum of 48 weeks

    Number of subjects in period 2
    		Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin
    Started
    20
    10
    Completed
    18
    9
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    1
         not present in CSR Final
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Peginterferon Lambda-1a + Ribavirin
    Reporting group description
    		 Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks

    Reporting group title
    Peginterferon alfa-2a + Ribavirin
    Reporting group description
    		 Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks

    Reporting group values
    		 Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin Total
    Number of subjects
    		 26 13 39
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 25 11 36
        From 65-84 years
    		 1 2 3
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.8 ( 10.98 ) 49.6 ( 12.31 ) -
    Gender categorical
    Units: Subjects
        Female
    		 17 1 18
        Male
    		 9 12 21

    End points

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    End points reporting groups
    Reporting group title
    Peginterferon Lambda-1a + Ribavirin
    Reporting group description
    		 Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks

    Reporting group title
    Peginterferon alfa-2a + Ribavirin
    Reporting group description
    		 Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
    Reporting group title
    Peginterferon Lambda-1a + Ribavirin
    Reporting group description
    		 Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks

    Reporting group title
    Peginterferon alfa-2a + Ribavirin
    Reporting group description
    		 Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks

    Primary: Percentage of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects

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    End point title
    		 Percentage of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects [1]
    End point description
    Subjects in treatment with GT-1 chronic HCV (hepatitis C virus) infection the display cytopenic abnormalities (anemia is defined by Hb < 100 g/L, neutropenia as defined by ANC < 0.75 X 10*9 C/L and thrombocytopenia as defined by platelets < 50 X 10*9 C/L). Subjects in treatment with GT-1 chronic HCV (hepatitis C virus) infection *ANC - Absolute Neutrophil Count *Hb - Hemoglobin
    End point type
    Primary
    End point timeframe
    Up to 48 weeks of treatment
    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 summary statistics were planned for this endpoint.
    End point values
    		 Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin
    Number of subjects analysed
    26
    13
    Units: percentage
    number (not applicable)
        Anemia
    0
    38.5
        Neutropenia
    3.8
    38.5
        Thrombocytopenia
    0
    7.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected)

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    End point title
    		 Percentage of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected) [2]
    End point description
    virologic responses for HCV RNA assessments
    End point type
    Secondary
    End point timeframe
    On treatment Week 4 (of an up to 48-week treatment period)
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only these measurements were made for this endpoint.
    End point values
    		 Peginterferon Lambda-1a + Ribavirin
    Number of subjects analysed
    26
    Units: percentage
        number (not applicable)
    23.1
    No statistical analyses for this end point

    Secondary: Percentage of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment

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    End point title
    		 Percentage of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment [3]
    End point description
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks of treatment
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only these measurements were made for this endpoint.
    End point values
    		 Peginterferon Lambda-1a + Ribavirin
    Number of subjects analysed
    26
    Units: percentage
        number (not applicable)
    11.5
    No statistical analyses for this end point

    Secondary: Percentage of subjects with dose reductions through end of treatment with Lambda (peginterferon lambda-1a)

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    End point title
    		 Percentage of subjects with dose reductions through end of treatment with Lambda (peginterferon lambda-1a)
    End point description
    The proportion of subjects who required one or more dose reductions during treatment with Lambda
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks of treatment
    End point values
    		 Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin
    Number of subjects analysed
    26
    13
    Units: percentage
    number (not applicable)
        Hematologic Toxicity
    0
    0
        Non-hematologic Toxicity
    0
    0
        Elevated Liver Function Tests
    11.5
    0
    No statistical analyses for this end point

    Secondary: Percentage of subjects with dose reductions through end of treatment with Alfa (peginterferon alfa-2a)

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    End point title
    		 Percentage of subjects with dose reductions through end of treatment with Alfa (peginterferon alfa-2a)
    End point description
    The proportion of subjects who required one or more dose reductions during treatment with Alfa
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks of treatment
    End point values
    		 Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin
    Number of subjects analysed
    26
    13
    Units: percentage
    number (not applicable)
        Hematologic Toxicity
    0
    46.2
        Non-hematologic Toxicity
    0
    46.2
        Elevated Liver Function Tests
    0
    7.7
    No statistical analyses for this end point

    Secondary: Percentage of subjects with dose reductions through end of treatment with Ribavirin

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    End point title
    		 Percentage of subjects with dose reductions through end of treatment with Ribavirin
    End point description
    The proportion of subjects who required one or more dose reductions during treatment with Ribavirin
    End point type
    Secondary
    End point timeframe
    up to 48 weeks of treatment
    End point values
    		 Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin
    Number of subjects analysed
    26
    13
    Units: percentage
    number (not applicable)
        Hematologic Toxicity
    0
    30.8
        Non-Hematologic Toxicity
    0
    7.7
        Elevated Liver Function Tests
    3.8
    0
    No statistical analyses for this end point

    Secondary: Percentage of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting

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    End point title
    		 Percentage of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting
    End point description
    On-treatment IFN-associated symptoms are: • Musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain) • Neurological symptoms (headache or dizziness) • Psychiatric symptoms (depression or irritability or insomnia) • General Disorders including: Constitutional symptoms (fatigue or asthenia) • Flu-like symptoms (as defined by pyrexia or chills or pain)
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks of treatment
    End point values
    		 Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin
    Number of subjects analysed
    26
    13
    Units: percentage
    number (not applicable)
        General Disorders (Symptoms)
    46.2
    46.2
        Musculoskeletal Symptoms
    11.5
    30.8
        Neurological (Nervous System) Symptoms
    23.1
    46.2
        Psychiatric Symptoms
    46.2
    15.4
    No statistical analyses for this end point

    Secondary: Percentage of subjects who discontinue due to Adverse Events (AEs) through end of treatment

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    End point title
    		 Percentage of subjects who discontinue due to Adverse Events (AEs) through end of treatment
    End point description
    Subjects who did not complete full planned treatment duration
    End point type
    Secondary
    End point timeframe
    Up to 48 weeks of treatment
    End point values
    		 Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin
    Number of subjects analysed
    26
    13
    Units: percentage
        number (not applicable)
    23.1
    46.2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From initiation of study drug to 30 days following discontinuation of drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Peginterferon Lambda-1a + Ribavirin
    Reporting group description
    		 Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks

    Reporting group title
    Peginterferon alfa-2a + Ribavirin
    Reporting group description
    		 Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks

    Serious adverse events
    		 Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 26 (11.54%)
    0 / 13 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Papillary Thyroid Cancer
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis Acute
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infective chondritis
    alternative dictionary used: MedDRA 17.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 26 (3.85%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Peginterferon Lambda-1a + Ribavirin Peginterferon alfa-2a + Ribavirin
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 26 (88.46%)
    11 / 13 (84.62%)
    General disorders and administration site conditions
    Fatigue
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    5 / 26 (19.23%)
    2 / 13 (15.38%)
         occurrences all number
    5
    2
    Injection Site Rash
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    3 / 26 (11.54%)
    0 / 13 (0.00%)
         occurrences all number
    3
    0
    Influenza Like Illness
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Pyrexia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 13 (15.38%)
         occurrences all number
    1
    2
    Asthenia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    3 / 13 (23.08%)
         occurrences all number
    0
    3
    Chest Pain
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Fat Tissue Increased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 13 (15.38%)
         occurrences all number
    2
    2
    Oropharyngeal Pain
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Dyspnoea Exertional
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Productive Cough
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Pulmonary Mass
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Insomnia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    10 / 26 (38.46%)
    0 / 13 (0.00%)
         occurrences all number
    10
    0
    Depression
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    3 / 26 (11.54%)
    2 / 13 (15.38%)
         occurrences all number
    3
    2
    Investigations
    Aspartate Aminotransferase Increased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Alanine Aminotransferase Increased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 26 (7.69%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Haemoglobin Decreased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Neutrophil Count Decreased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Platelet Count Decreased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Weight Decreased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    White Blood Cell Count Decreased
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Ligament Injury
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Cardiac disorders
    Palpitations
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Nervous system disorders
    Headache
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    6 / 26 (23.08%)
    3 / 13 (23.08%)
         occurrences all number
    6
    3
    Paraesthesia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Dizziness
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    4 / 13 (30.77%)
         occurrences all number
    0
    4
    Disturbance in Attention
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Neutropenia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    5 / 13 (38.46%)
         occurrences all number
    0
    5
    Leukopenia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Anaemia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Lymphadenpathy
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Eye disorders
    Ocular Hyperaemia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Dyspepsia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    5 / 26 (19.23%)
    1 / 13 (7.69%)
         occurrences all number
    5
    1
    Nausea
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    4 / 26 (15.38%)
    4 / 13 (30.77%)
         occurrences all number
    4
    4
    Diarrhoea
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 13 (15.38%)
         occurrences all number
    2
    2
    Abdominal Pain Upper
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Dry Mouth
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Toothache
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Jaundice
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 26 (7.69%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Hypertranaminasaemia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    6 / 26 (23.08%)
    2 / 13 (15.38%)
         occurrences all number
    6
    2
    Rash
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    3 / 26 (11.54%)
    2 / 13 (15.38%)
         occurrences all number
    3
    2
    Alopecia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    3 / 13 (23.08%)
         occurrences all number
    1
    3
    Dermatitis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Dry Skin
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Dermatitis Contact
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Rash Erythematous
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Rash Generalised
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 26 (7.69%)
    2 / 13 (15.38%)
         occurrences all number
    2
    2
    Back Pain
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Intervertebral Disc Protrusion
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    2 / 13 (15.38%)
         occurrences all number
    0
    2
    Arthralgia
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Pain In Extremity
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Infections and infestations
    Upper Respiratory Tract Infection
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    2 / 13 (15.38%)
         occurrences all number
    1
    2
    Nasopharyngitis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    1 / 26 (3.85%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Gastroenteritis
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Oral Herpes
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Otitis Media Acute
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    0 / 26 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased Appetite
    alternative dictionary used: MedDRA 17.0
         subjects affected / exposed
    2 / 26 (7.69%)
    4 / 13 (30.77%)
         occurrences all number
    2
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jul 2013
    The amendment is intended to exclude cirrhotics patients for enrollment in this study based on recent safety updates from patients who received Lambda, to incorporate updates and clarifications to study procedures and typo corrections and to incorporate some administrative changes.

    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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