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    Clinical Trial Results:
    A Phase 3, Safety and Efficacy Study of Boceprevir/Peginterferon Alfa-2a/ribavirin in Chronic HCV Genotype 1 IL28B CC Subjects (P07755)

    Summary
    EudraCT number
    		 2011-001345-32
    Trial protocol
    		 PT   ES   CZ   SE   AT   BE   DE   GB   PL   LT   EE   HU  
    Global end of trial date
    19 May 2015

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    P07755
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01544920
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Merck Protocol No.: MK-3034-040
    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
    19 May 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    19 May 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary purpose of this study is to compare the efficacy of two boceprevir (BOC)-containing therapeutic regimens in the treatment of naïve participants with chronic hepatitis C virus (HCV) genotype 1 who have the IL28B CC allele. The regimens differ in the treatment for participants who achieve undetectable HCV ribonucleic acid (RNA) at the end of the peginterferon alfa-2a (peg-IFN) plus ribavirin (RBV) 4 week lead-in. Participants receive either peg-IFN + RBV (Arm 1) or BOC + peg-IFN + RBV (Arm 2). The hypothesis is that Arm 2 is noninferior to Arm 1 in the proportion of participants with undetectable HCV RNA at Follow-Up (FU) Week 24.
    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
    30 May 2012
    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
    Argentina: 21
    Country: Number of subjects enrolled
    Australia: 11
    Country: Number of subjects enrolled
    Austria: 20
    Country: Number of subjects enrolled
    Brazil: 10
    Country: Number of subjects enrolled
    Canada: 23
    Country: Number of subjects enrolled
    Chile: 7
    Country: Number of subjects enrolled
    Colombia: 1
    Country: Number of subjects enrolled
    Czech Republic: 26
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 18
    Country: Number of subjects enrolled
    Guatemala: 1
    Country: Number of subjects enrolled
    Hong Kong: 9
    Country: Number of subjects enrolled
    Israel: 15
    Country: Number of subjects enrolled
    Korea, Republic of: 34
    Country: Number of subjects enrolled
    Malaysia: 40
    Country: Number of subjects enrolled
    Mexico: 11
    Country: Number of subjects enrolled
    New Zealand: 6
    Country: Number of subjects enrolled
    Peru: 2
    Country: Number of subjects enrolled
    Philippines: 31
    Country: Number of subjects enrolled
    Poland: 103
    Country: Number of subjects enrolled
    Portugal: 11
    Country: Number of subjects enrolled
    Russian Federation: 149
    Country: Number of subjects enrolled
    Singapore: 8
    Country: Number of subjects enrolled
    Spain: 24
    Country: Number of subjects enrolled
    Sweden: 9
    Country: Number of subjects enrolled
    Taiwan: 12
    Country: Number of subjects enrolled
    Thailand: 20
    Country: Number of subjects enrolled
    Turkey: 8
    Country: Number of subjects enrolled
    United States: 106
    Worldwide total number of subjects
    737
    EEA total number of subjects
    212
    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)
    711
    From 65 to 84 years
    26
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Adult male and female participants infected with the HCV genotype (GT) 1 with IL-28B CC gene allele and no evidence of liver cirrhosis or hepatocellular carcinoma were recruited.

    Pre-assignment
    Screening details
    		 The screening period lasted 8 weeks.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1: peg-IFN + RBV
    Arm description
    		 Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
    Arm type
    		 Active comparator

    Investigational medicinal product name
    peg-Interferon alfa-2a (peg-IFN)
    Investigational medicinal product code
    Other name
    Pegasys™; SCH 054031
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    peg-IFN (180 µg) was taken once weekly via subcutaneous injection.

    Investigational medicinal product name
    Ribavirin (RBV)
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV 200 mg tablets were taken by mouth at a total daily dose of 1,000 mg (body weight <75 kg) or 1,200 mg (body weight ≥75 kg) with total daily dose divided into 2 separate dosings.

    Arm title
    		 Arm 2: BOC + Peg-IFN + RBV
    Arm description
    		 Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
    Arm type
    		 Experimental

    Investigational medicinal product name
    peg-Interferon alfa-2a (peg-IFN)
    Investigational medicinal product code
    Other name
    Pegasys™; SCH 054031
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    peg-IFN (180 µg) was taken once weekly via subcutaneous injection.

    Investigational medicinal product name
    Boceprevir (BOC)
    Investigational medicinal product code
    Other name
    Victrelis™; SCH 503034
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    BOC was taken as four 200 mg capsules taken three times daily at a total daily dose of 2,400 mg.

    Investigational medicinal product name
    Ribavirin (RBV)
    Investigational medicinal product code
    Other name
    Rebetol™
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    RBV 200 mg tablets were taken by mouth at a total daily dose of 1,000 mg (body weight <75 kg) or 1,200 mg (body weight ≥75 kg) with total daily dose divided into 2 separate dosings.

    Number of subjects in period 1
    		Arm 1: peg-IFN + RBV Arm 2: BOC + Peg-IFN + RBV
    Started
    368
    369
    Completed
    349
    346
    Not completed
    19
    23
         Adverse event, serious fatal
    -
    1
         Physician decision
    4
    1
         Consent withdrawn by subject
    4
    4
         Adverse event, non-fatal
    -
    3
         Lost to follow-up
    11
    12
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: peg-IFN + RBV
    Reporting group description
    		 Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].

    Reporting group title
    Arm 2: BOC + Peg-IFN + RBV
    Reporting group description
    		 Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].

    Reporting group values
    		 Arm 1: peg-IFN + RBV Arm 2: BOC + Peg-IFN + RBV Total
    Number of subjects
    		 368 369 737
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 352 359 711
        From 65-84 years
    		 16 10 26
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 43.9 ( 12 ) 42.4 ( 12.4 ) -
    Gender, Male/Female
    Units: Participants
        Female
    		 167 148 315
        Male
    		 201 221 422

    End points

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    End points reporting groups
    Reporting group title
    Arm 1: peg-IFN + RBV
    Reporting group description
    		 Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].

    Reporting group title
    Arm 2: BOC + Peg-IFN + RBV
    Reporting group description
    		 Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].

    Subject analysis set title
    Arm 1a: peg-IFN + RBV 24 weeks
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of peg-IFN + RBV for a total of 24 weeks of peg-IFN + RBV therapy.

    Subject analysis set title
    Arm 2a: BOC + peg-IFN + RBV 24 weeks
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of BOC + peg-IFN + RBV for a total of 24 weeks of BOC (added at Week 4) + peg-IFN + RBV therapy.

    Primary: Percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing study treatment (SVR24)

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    End point title
    		 Percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) 24 weeks after completing study treatment (SVR24)
    End point description
    SVR24 rates were determined for all participants in Arm 1 and Arm 2. HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL. The Full Analysis Set (FAS) consisted of all participants who completed the 4-week peg-IFN + RBV lead-in and who were randomized at Week 4.
    End point type
    Primary
    End point timeframe
    Up to Week 74
    End point values
    		 Arm 1: peg-IFN + RBV Arm 2: BOC + Peg-IFN + RBV
    Number of subjects analysed
    368
    369
    Units: Percentage of participants
        number (not applicable)
    86.7
    88.3
    Statistical analysis title
    		 Difference in SVR24 Percentage
    Statistical analysis description
    This SVR24 analysis includes all participants.
    Comparison groups
    Arm 1: peg-IFN + RBV v Arm 2: BOC + Peg-IFN + RBV
    Number of subjects included in analysis
    737
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in SVR24% in Arm 2 vs. Arm 1
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 6.5
    Notes
    [1] - Non-inferiority was declared if the lower bound of the 95% CI of the difference in SVR24 % exceeded -10%.

    Secondary: Percentage of participants who had undetectable HCV RNA at Week 4 achieving SVR24

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    End point title
    		 Percentage of participants who had undetectable HCV RNA at Week 4 achieving SVR24
    End point description
    SVR24 rates were determined for only participants that had undetectable HCV RNA at Week 4 of treatment (Arm 1a and Arm 2a). HCV RNA viral load was determined using the Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test v1.0, which has a lower limit of quantification of 43 IU/mL. The analysis set consisted of all participants who completed the 4-week peg-IFN + RBV lead-in, were randomized at Week 4, and had undetectable HCV RNA at Week 4.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 Arm 1a: peg-IFN + RBV 24 weeks Arm 2a: BOC + peg-IFN + RBV 24 weeks
    Number of subjects analysed
    108
    107
    Units: Percentage of participants
        number (not applicable)
    87
    97.2
    Statistical analysis title
    		 Difference in SVR24 percentage
    Statistical analysis description
    This SVR24 analysis includes only the participants with undetectable HCV RNA at Week 4.
    Comparison groups
    Arm 1a: peg-IFN + RBV 24 weeks v Arm 2a: BOC + peg-IFN + RBV 24 weeks
    Number of subjects included in analysis
    215
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in SVR24%
    Point estimate
    10.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.5
         upper limit
    		 18.1
    Notes
    [2] - The observed lower bound of the 95% CI for the difference was 2.5% (which exceeds 0) for BOC added to peg-IFN + RBV in contrast to peg-IFN + RBV alone.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 78 weeks
    Adverse event reporting additional description
    An adverse event (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. The All Participants as Treated (APaT) population includes all participants who received at least one dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    .18.0
    Reporting groups
    Reporting group title
    Arm 2: BOC + peg-IFN + RBV
    Reporting group description
    		 Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].

    Reporting group title
    Arm 1: peg-IFN + RBV
    Reporting group description
    		 Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].

    Serious adverse events
    		 Arm 2: BOC + peg-IFN + RBV Arm 1: peg-IFN + RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    37 / 369 (10.03%)
    27 / 368 (7.34%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Conjunctival melanoma
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Deep vein thrombosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Malaise
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 369 (0.54%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Miscarriage of partner
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Uterine haemorrhage
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleurisy
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Adjustment disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Depression
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychotic disorder
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suicide attempt
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Activated partial thromboplastin time prolonged
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutrophil count decreased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prothrombin time prolonged
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental overdose
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alcohol poisoning
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ligament sprain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic haematoma
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrioventricular block first degree
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (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
    Dizziness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (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
    2 / 369 (0.54%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    3 / 368 (0.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancytopenia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain upper
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric ulcer
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory bowel disease
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholecystitis chronic
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Rash
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal cyst
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Autoimmune thyroiditis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthyroidism
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Lumbar spinal stenosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis viral
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 369 (0.54%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes pharyngitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lobar pneumonia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    3 / 369 (0.81%)
    4 / 368 (1.09%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary tuberculosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    2 / 369 (0.54%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis chronic
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Decreased appetite
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    0 / 369 (0.00%)
    1 / 368 (0.27%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    1 / 369 (0.27%)
    0 / 368 (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
    		 Arm 2: BOC + peg-IFN + RBV Arm 1: peg-IFN + RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    351 / 369 (95.12%)
    348 / 368 (94.57%)
    Investigations
    Haemoglobin decreased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    31 / 369 (8.40%)
    24 / 368 (6.52%)
         occurrences all number
    33
    29
    Neutrophil count decreased
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    29 / 369 (7.86%)
    24 / 368 (6.52%)
         occurrences all number
    41
    30
    Nervous system disorders
    Dizziness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    42 / 369 (11.38%)
    46 / 368 (12.50%)
         occurrences all number
    48
    51
    Dysgeusia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    94 / 369 (25.47%)
    65 / 368 (17.66%)
         occurrences all number
    95
    69
    Headache
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    100 / 369 (27.10%)
    118 / 368 (32.07%)
         occurrences all number
    148
    152
    Blood and lymphatic system disorders
    Anaemia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    168 / 369 (45.53%)
    169 / 368 (45.92%)
         occurrences all number
    210
    219
    Leukopenia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    33 / 369 (8.94%)
    39 / 368 (10.60%)
         occurrences all number
    46
    66
    Neutropenia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    108 / 369 (29.27%)
    109 / 368 (29.62%)
         occurrences all number
    161
    194
    Thrombocytopenia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    24 / 369 (6.50%)
    19 / 368 (5.16%)
         occurrences all number
    28
    24
    General disorders and administration site conditions
    Asthenia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    74 / 369 (20.05%)
    82 / 368 (22.28%)
         occurrences all number
    90
    108
    Chills
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    26 / 369 (7.05%)
    36 / 368 (9.78%)
         occurrences all number
    32
    39
    Fatigue
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    117 / 369 (31.71%)
    118 / 368 (32.07%)
         occurrences all number
    154
    135
    Influenza like illness
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    35 / 369 (9.49%)
    34 / 368 (9.24%)
         occurrences all number
    48
    39
    Pyrexia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    148 / 369 (40.11%)
    101 / 368 (27.45%)
         occurrences all number
    243
    148
    Gastrointestinal disorders
    Abdominal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    22 / 369 (5.96%)
    18 / 368 (4.89%)
         occurrences all number
    26
    18
    Abdominal pain upper
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    14 / 369 (3.79%)
    22 / 368 (5.98%)
         occurrences all number
    18
    26
    Diarrhoea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    49 / 369 (13.28%)
    62 / 368 (16.85%)
         occurrences all number
    55
    77
    Dry mouth
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    26 / 369 (7.05%)
    25 / 368 (6.79%)
         occurrences all number
    28
    26
    Dyspepsia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    35 / 369 (9.49%)
    23 / 368 (6.25%)
         occurrences all number
    39
    25
    Nausea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    94 / 369 (25.47%)
    100 / 368 (27.17%)
         occurrences all number
    112
    117
    Vomiting
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    53 / 369 (14.36%)
    46 / 368 (12.50%)
         occurrences all number
    78
    68
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    52 / 369 (14.09%)
    66 / 368 (17.93%)
         occurrences all number
    56
    83
    Dyspnoea
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    34 / 369 (9.21%)
    34 / 368 (9.24%)
         occurrences all number
    38
    36
    Oropharyngeal pain
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    20 / 369 (5.42%)
    11 / 368 (2.99%)
         occurrences all number
    22
    13
    Skin and subcutaneous tissue disorders
    Alopecia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    70 / 369 (18.97%)
    72 / 368 (19.57%)
         occurrences all number
    74
    76
    Dry skin
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    41 / 369 (11.11%)
    44 / 368 (11.96%)
         occurrences all number
    41
    45
    Pruritus
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    77 / 369 (20.87%)
    75 / 368 (20.38%)
         occurrences all number
    84
    85
    Rash
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    67 / 369 (18.16%)
    69 / 368 (18.75%)
         occurrences all number
    85
    82
    Psychiatric disorders
    Anxiety
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    14 / 369 (3.79%)
    26 / 368 (7.07%)
         occurrences all number
    14
    29
    Depression
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    20 / 369 (5.42%)
    29 / 368 (7.88%)
         occurrences all number
    22
    38
    Insomnia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    53 / 369 (14.36%)
    70 / 368 (19.02%)
         occurrences all number
    57
    73
    Irritability
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    28 / 369 (7.59%)
    38 / 368 (10.33%)
         occurrences all number
    28
    43
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    45 / 369 (12.20%)
    44 / 368 (11.96%)
         occurrences all number
    52
    49
    Myalgia
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    58 / 369 (15.72%)
    61 / 368 (16.58%)
         occurrences all number
    74
    79
    Metabolism and nutrition disorders
    Decreased appetite
    alternative dictionary used: MedDRA 18.0
         subjects affected / exposed
    53 / 369 (14.36%)
    54 / 368 (14.67%)
         occurrences all number
    55
    60

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2012
    AM1: The primary purpose of was to clarify the language on birth control, modify the previously documented CHC -1 genotype Inclusion Criterion #5, and to update the study flow charts to include visit windows and to remove Chest X-Ray and inosine triphosphate pyrophosphohydrolase (ITPA) sample collection.
    21 May 2013
    AM2: The primary purpose was to allow retesting of platelet count at Screening Visit, add an interim analysis of SVR12 and SVR when all participants in Arm 1a and Arm 2a have completed FW 12 and 24.
    16 Jul 2013
    AM3: The primary purpose was to re-insert text that restricts participants from entering the study if they were planning to donate sperm or eggs while participating in the study.
    10 Feb 2014
    AM4: The primary purpose was to add results and conclusion from a review of pooled data (blinded to treatment), the interim analysis, that was conducted after 40% (first 500 IL28B CC subjects) of participants overall have completed 4 weeks of PEG2a/RBV lead-in and have been randomized in order to assess the assumed estimates of the proportion of screened participants with IL28B CC and the proportion with undetectable HCV RNA at Week 4.
    16 Jun 2014
    AM5: The primary purpose was to provide more details on the statistical power for the primary analysis and describe the key secondary analysis.

    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
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