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    Clinical Trial Results:
    A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C Virus Infection with Advanced Cirrhosis and Child-Pugh (CP)-B Hepatic Insufficiency

    Summary
    EudraCT number
    		 2014-000672-25
    Trial protocol
    		 LT   ES   NL   EE   PL   IT   GB  
    Global end of trial date
    09 Sep 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    5172-059
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02115321
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 MK-5172-059: Merck Protocol 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
    16 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) taken once daily (q.d.) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP) score 7-9 moderate hepatic insufficiency (CP-B). The primary hypothesis is that the percentage of HCV-infected participants with hepatic insufficiency (the CP-B population) achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12) will be greater than 60%. Additionally, ten non-cirrhotic (NC) HCV-infected GT1 participants will also be given GZR + EBR at the beginning of the study; this will be done for the purpose of collecting plasma pharmacokinetic (PK) data in HCV GT1-infected participants who do not have hepatic insufficiency.
    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
    09 May 2014
    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
    United States: 40
    Worldwide total number of subjects
    40
    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)
    34
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was halted after enrolling participants in the two Part A arms, as the current clinical development plan is focused on a fixed-dose combination (FDC) product containing grazoprevir (GZR) 100 mg and elbasvir (EBR) 50 mg. No participants were enrolled in Parts B or C.

    Pre-assignment
    Screening details
    		 The screening period lasted for 60 days.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Part A: CP-B GZR 50 mg + EBR 50 mg
    Arm description
    		 CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EBR 50 mg was supplied as either EBR tablets or contained in the MK-5172A FDC and was taken q.d. by mouth.

    Investigational medicinal product name
    Grazoprevir
    Investigational medicinal product code
    Other name
    MK-5172
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GZR was supplied as two 25 mg tablets in the Part A CP-B arm, or as either one GZR 100 mg tablet or one fixed-dose combination (FDC) tablet containing GZR 100 mg + EBR 50 mg in a single tablet (MK-5172A) in the Part A NC arm. GZR was taken once daily (q.d.) by mouth.

    Arm title
    		 Part A: NC GZR 100 mg + EBR 50 mg
    Arm description
    		 NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elbasvir
    Investigational medicinal product code
    Other name
    MK-8742
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    EBR 50 mg was supplied as either EBR tablets or contained in the MK-5172A FDC and was taken q.d. by mouth.

    Investigational medicinal product name
    Grazoprevir
    Investigational medicinal product code
    Other name
    MK-5172
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    GZR was supplied as two 25 mg tablets in the Part A CP-B arm, or as either one GZR 100 mg tablet or one FDC tablet containing GZR 100 mg + EBR 50 mg in a single tablet (MK-5172A) in the Part A NC arm. GZR was taken q.d. by mouth.

    Number of subjects in period 1
    		Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Started
    30
    10
    Completed
    29
    10
    Not completed
    1
    0
         Adverse event, serious fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Part A: CP-B GZR 50 mg + EBR 50 mg
    Reporting group description
    		 CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.

    Reporting group title
    Part A: NC GZR 100 mg + EBR 50 mg
    Reporting group description
    		 NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.

    Reporting group values
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg Total
    Number of subjects
    		 30 10 40
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 26 8 34
        From 65-84 years
    		 4 2 6
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 58.3 ( 7 ) 60.4 ( 5.3 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 13 5 18
        Male
    		 17 5 22

    End points

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    End points reporting groups
    Reporting group title
    Part A: CP-B GZR 50 mg + EBR 50 mg
    Reporting group description
    		 CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.

    Reporting group title
    Part A: NC GZR 100 mg + EBR 50 mg
    Reporting group description
    		 NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.

    Primary: Percentage of participants achieving sustained viral response 12 weeks after completing study therapy (SVR12)

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    End point title
    		 Percentage of participants achieving sustained viral response 12 weeks after completing study therapy (SVR12) [1]
    End point description
    SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels below the lower limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
    End point type
    Primary
    End point timeframe
    Week 24 (Follow-up [FU] 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: Per protocol, only descriptive statistics are presented.
    End point values
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Number of subjects analysed
    30
    10
    Units: Percentage of participants
        number (confidence interval 95%)
    90 (73.5 to 97.9)
    100 (69.2 to 100)
    No statistical analyses for this end point

    Primary: Number of participants experiencing an adverse event (AE) during treatment and first 14 follow-up days

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    End point title
    		 Number of participants experiencing an adverse event (AE) during treatment and first 14 follow-up days [2]
    End point description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    End point type
    Primary
    End point timeframe
    Up to 14 weeks
    Notes
    [2] - 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: Per protocol, only descriptive statistics are presented.
    End point values
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Number of subjects analysed
    30
    10
    Units: Number of participants
    25
    8
    No statistical analyses for this end point

    Primary: Number of participants discontinuing study drug due to an AE

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    End point title
    		 Number of participants discontinuing study drug due to an AE [3]
    End point description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    End point type
    Primary
    End point timeframe
    Up to 12 weeks
    Notes
    [3] - 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: Per protocol, only descriptive statistics are presented.
    End point values
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Number of subjects analysed
    30
    10
    Units: Number of participants
    0
    0
    No statistical analyses for this end point

    Secondary: Mean change from baseline in Model for End-Stage Liver Disease (MELD) scores in CP-B participants

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    End point title
    		 Mean change from baseline in Model for End-Stage Liver Disease (MELD) scores in CP-B participants
    End point description
    The MELD score provides an objective and granular assessment of liver improvement as a continuous variable. The calculation of MELD score is based on three biochemical variables (serum bilirubin, creatinine and international normalized ratio [INR] of prothrombin time). The MELD equation is as follows: 9.57 x ln(creatinine mg/dL) +3.78 x ln (bilirubin mg/dL) + 11.2 x ln(INR) + 6.43. Scores are multiplied by 10 and rounded to the nearest whole number and range from 6 (less ill) to 40 (gravely ill). MELD scores were determined at Baseline (Day 1) and again at Week 12, FU Week 12 (Week 24), and FU Week 24 (Week 36). Change from baseline in MELD score = Post-baseline MELD score - baseline MELD score.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 12, 24, and 36
    End point values
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Number of subjects analysed
    30
    0 [4]
    Units: Units on a scale
    arithmetic mean (standard deviation)
        Week 12 (n=30)
    -0.67 ( 1.35 )
    ( )
        FU Week 12 (Week 24) [n=29]
    -0.38 ( 1.74 )
    ( )
        FU Week 24 (Week 36) [n=29]
    -0.34 ( 3.15 )
    ( )
    Notes
    [4] - MELD scores are not applicable to NC participants.
    No statistical analyses for this end point

    Secondary: Percentage of participants with HCV RNA undetectable at Weeks 2, 4, and 12

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    End point title
    		 Percentage of participants with HCV RNA undetectable at Weeks 2, 4, and 12
    End point description
    HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
    End point type
    Secondary
    End point timeframe
    Week 2, 4, and 12
    End point values
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: Percentage of participants
        number (confidence interval)
    ( to )
    ( to )
    Notes
    [5] - This was to be determined in Part C; enrollment was halted after Part A and no data are available.
    [6] - This was to be determined in Part C; enrollment was halted after Part A and no data are available.
    No statistical analyses for this end point

    Secondary: Percentage of participants with HCV RNA <LLoQ at Weeks 2, 4, and 12

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    End point title
    		 Percentage of participants with HCV RNA <LLoQ at Weeks 2, 4, and 12
    End point description
    HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
    End point type
    Secondary
    End point timeframe
    Weeks 2, 4, and 12
    End point values
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: Percentage of participants
        number (confidence interval)
    ( to )
    ( to )
    Notes
    [7] - This was to be determined in Part C; enrollment was halted after Part A and no data are available.
    [8] - This was to be determined in Part C; enrollment was halted after Part A and no data are available.
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving sustained viral response 4 weeks after completing study therapy (SVR4)

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    End point title
    		 Percentage of participants achieving sustained viral response 4 weeks after completing study therapy (SVR4)
    End point description
    SVR4 was defined as HCV RNA levels <LLoQ 4 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
    End point type
    Secondary
    End point timeframe
    Week 16
    End point values
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Number of subjects analysed
    30
    10
    Units: Percentage of participants
        number (confidence interval 95%)
    93.3 (77.9 to 99.2)
    100 (69.2 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of participants achieving sustained viral response 24 weeks after completing study therapy (SVR24)

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    End point title
    		 Percentage of participants achieving sustained viral response 24 weeks after completing study therapy (SVR24)
    End point description
    SVR24 was defined as HCV RNA levels <LLoQ 24 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
    End point type
    Secondary
    End point timeframe
    Week 36
    End point values
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Number of subjects analysed
    30
    10
    Units: Percentage of participants
        number (confidence interval 95%)
    90 (73.5 to 97.9)
    100 (69.2 to 100)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 36 weeks.
    Adverse event reporting additional description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Part A: CP-B GZR 50 mg + EBR 50 mg
    Reporting group description
    		 CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.

    Reporting group title
    Part A: NC GZR 100 mg + EBR 50 mg
    Reporting group description
    		 NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.

    Serious adverse events
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 30 (16.67%)
    0 / 10 (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)
    Hepatocellular carcinoma
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral infarction
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Ascites
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varices oesophageal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic failure
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Peritonitis bacterial
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Malnutrition
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 30 (3.33%)
    0 / 10 (0.00%)
         occurrences causally related to treatment / all
    0 / 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
    		 Part A: CP-B GZR 50 mg + EBR 50 mg Part A: NC GZR 100 mg + EBR 50 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 30 (66.67%)
    8 / 10 (80.00%)
    General disorders and administration site conditions
    Chills
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Fatigue
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    9 / 30 (30.00%)
    3 / 10 (30.00%)
         occurrences all number
    11
    3
    Feeling abnormal
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Pyrexia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Oropharyngeal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Sinus congestion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Affect lability
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Insomnia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Investigations
    Blood creatine phosphokinase increased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Ligament sprain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Muscle strain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Headache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 30 (10.00%)
    5 / 10 (50.00%)
         occurrences all number
    3
    6
    Sinus headache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Increased tendency to bruise
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear discomfort
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Eye disorders
    Retinal detachment
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 30 (3.33%)
    1 / 10 (10.00%)
         occurrences all number
    1
    1
    Abdominal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 30 (6.67%)
    1 / 10 (10.00%)
         occurrences all number
    2
    1
    Abdominal pain upper
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Diarrhoea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Nausea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 30 (10.00%)
    2 / 10 (20.00%)
         occurrences all number
    3
    2
    Vomiting
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Constipation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    5 / 30 (16.67%)
    2 / 10 (20.00%)
         occurrences all number
    5
    3
    Myalgia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 30 (6.67%)
    0 / 10 (0.00%)
         occurrences all number
    2
    0
    Infections and infestations
    Influenza
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Tooth infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1
    Urinary tract infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 30 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    3
    0
    Pneumonia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 30 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Mar 2014
    Amendment 1: Updated the laboratory exclusion criterion (EC) of platelets from < 40 x 10^3/μL to < 30 x 10^3/μL for CP-B participants and added the laboratory EC of creatinine clearance <30 mL/min for both populations.
    16 Apr 2014
    Amendment 2: Modified to indicate study will be discontinued if 3 or more CP-B participants in Part A have alanine transaminase (ALT) or aspartate transaminase (AST) elevations >5 times the upper limit of normal (ULN) after treatment week (TW) 4.
    04 Aug 2014
    Amendment 3: Modified laboratory EC for CP-B participants including (1) albumin changed from <2.8 grams/deciliter [g/dL] to <2.2 g/dL; and (2) hemoglobin changed from <10.5 g/dL to <9.5 g/dL.
    02 Mar 2015
    Amendment 4: An exploratory objective was added to evaluate improvement in neurocognitive function from Day 1 to end of treatment (EOT), follow-up (FU) Week 12, and FU Week 24 in Part C (Part C was not conducted).

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    09 Sep 2015
    Because the current development program is focused on a fixed dose combination product of 100 mg GZR + 50 mg EBR, it was decided not to proceed with the rest of the study. The study was terminated upon completion of Part A; no participants were enrolled in Parts B or C.
    -

    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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