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    Clinical Trial Results:
    A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Subjects with Genotype 1 Chronic Hepatitis C and Compensated Cirrhosis

    Summary
    EudraCT number
    		 2013-002458-66
    Trial protocol
    		 FR  
    Global end of trial date
    26 Nov 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    14 Jul 2016
    First version publication date
    23 Apr 2016
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction in non-serious AEs

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    AI443-113
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01973049
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Bristol-Myers Squibb
    Sponsor organisation address
    Bristol-Myers Squibb International Corporation, Chaussée de la Hulpe 185, Brussels, Belgium, 1170
    Public contact
    Bristol Myers Squibb Study Director, Bristol Myers Squibb, clinical.trials@bms.com
    Scientific contact
    Bristol Myers Squibb Study Director, Bristol Myers Squibb, clinical.trials@bms.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Nov 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the proportion of treatment-naive cirrhotic subjects in at least 1 of daclatasvir 3 direct acting antiviral (DCV 3DAA) daclatasvir/asunaprevir/beclabuvir administered as a fixed-dose combination with or without ribavirin (RIBAVIRIN) group with sustained virologic response at follow-up week 12 (SVR12), defined as hepatitis C virus (HCV) RNA below lower limit of quantitation (LLOQ) target detected or target not detected at follow-up week 12, was significantly greater than a historical threshold of 69 percent.
    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
    13 Dec 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 34
    Country: Number of subjects enrolled
    Canada: 35
    Country: Number of subjects enrolled
    United States: 196
    Country: Number of subjects enrolled
    France: 35
    Worldwide total number of subjects
    300
    EEA total number of subjects
    35
    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)
    251
    From 65 to 84 years
    49
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 48 sites in the United States, Canada, France and Australia.

    Pre-assignment
    Screening details
    		 A total of 300 subjects were enrolled and 202 were randomised and treated. Reason for not being randomised: adverse event (1), subject withdrew consent (2), poor/non-compliance (1), subject no longer meets study criteria (92) and administrative reason by sponsor (2).

    Period 1
    Period 1 title
    Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    This study was blinded for RBV/placebo assignment for sites, subjects and the Sponsor but open-label for DCV 3DAA therapy (daclatasvir/asunaprevir/BMS-791325).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Treatment-naive: DCV 3DAA
    Arm description
    		 Subjects (treatment naïve) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with placebo matched to ribavirin tablet orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    BMS-790052
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 30 mg tablet was administered orally twice daily (1 tablet in morning and 1 tablet in evening) with food for 12 weeks by treatment naive subjects.

    Investigational medicinal product name
    Asunaprevir
    Investigational medicinal product code
    BMS-650032
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Asunaprevir 200 mg was administered orally twice daily (1 tablet in morning and 1 tablet in evening) with food for 12 weeks by treatment naive subjects.

    Investigational medicinal product name
    Beclabuvir
    Investigational medicinal product code
    BMS-791325
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Beclabuvir 75 mg was administered orally twice daily (1 tablet in morning and 1 tablet in evening) with food for 12 weeks by treatment naive subjects.

    Investigational medicinal product name
    Placebo matched to ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to ribavirin was administered orally, twice daily in a body weight stratified dose range of 1000–1200 mg per day [total dose of 1000-mg per day for subjects weighing <75 kg (2 tablets in morning and 3 tablets in evening) and a total dose of 1200 mg per day for subjects weighing >=75 kg (3 tablets in morning and 3 tablets in evening)] by treatment naive subjects.

    Arm title
    		 Treatment-naive: DCV 3DAA + RBV
    Arm description
    		 Subjects (treatment naive) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with ribavirin 200 mg orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    BMS-790052
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 30 mg was administered orally twice daily with food for 12 weeks by treatment naive subjects.

    Investigational medicinal product name
    Asunaprevir
    Investigational medicinal product code
    BMS-650032
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Asunaprevir 200 mg was administered orally twice daily with food for 12 weeks by treatment naive subjects.

    Investigational medicinal product name
    Beclabuvir
    Investigational medicinal product code
    BMS-791325
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Beclabuvir 75 mg was administered orally twice daily with food for 12 weeks by treatment naive subjects.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Ribasphere®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 200 mg tablet was administered orally, twice daily in a body weight stratified dose range of 1000–1200 mg per day [total dose of 1000-mg per day for subjects weighing <75 kg (2 tablets in morning and 3 tablets in evening) and a total dose of 1200 mg per day for subjects weighing >=75 kg (3 tablets in morning and 3 tablets in evening)] by treatment naive subjects.

    Arm title
    		 Treatment-experienced: DCV 3DAA
    Arm description
    		 Subjects (treatment experienced) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with placebo matched to ribavirin tablet orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    BMS-790052
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 30 mg was administered orally twice daily with food for 12 weeks by treatment experienced subjects.

    Investigational medicinal product name
    Asunaprevir
    Investigational medicinal product code
    BMS-650032
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Asunaprevir 200 mg was administered orally twice daily with food for 12 weeks by treatment experienced subjects.

    Investigational medicinal product name
    Beclabuvir
    Investigational medicinal product code
    BMS-791325
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Beclabuvir 75 mg was administered orally twice daily with food for 12 weeks by treatment experienced subjects.

    Investigational medicinal product name
    Placebo matched to ribavirin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo matched to ribavirin was administered orally, twice daily in a body weight stratified dose range of 1000–1200 mg per day [total dose of 1000-mg per day for subjects weighing <75 kg (2 tablets in morning and 3 tablets in evening) and a total dose of 1200 mg per day for subjects weighing >=75 kg (3 tablets in morning and 3 tablets in evening)].

    Arm title
    		 Treatment-experienced: DCV 3DAA +RBV
    Arm description
    		 Subjects (treatment experienced) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with RIBAVIRIN 200 mg orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Daclatasvir
    Investigational medicinal product code
    BMS-790052
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Daclatasvir 30 mg tablet was administered orally twice daily with food for 12 weeks by treatment naive subjects.

    Investigational medicinal product name
    Asunaprevir
    Investigational medicinal product code
    BMS-650032
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Asunaprevir 200 mg was administered orally twice daily with food for 12 weeks by treatment experienced subjects.

    Investigational medicinal product name
    Beclabuvir
    Investigational medicinal product code
    BMS-791325
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Beclabuvir 75 mg was administered orally twice daily with food for 12 weeks by treatment experienced subjects.

    Investigational medicinal product name
    Ribavirin
    Investigational medicinal product code
    Other name
    Ribasphere®
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ribavirin 200 mg tablet was administered orally, twice daily in a body weight stratified dose range of 1000–1200 mg per day [total dose of 1000-mg per day for subjects weighing <75 kg (2 tablets in morning and 3 tablets in evening) and a total dose of 1200 mg per day for subjects weighing >=75 kg (3 tablets in morning and 3 tablets in evening)].

    Number of subjects in period 1 [1]
    		Treatment-naive: DCV 3DAA Treatment-naive: DCV 3DAA + RBV Treatment-experienced: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV
    Started
    57
    55
    45
    45
    Completed
    57
    55
    44
    43
    Not completed
    0
    0
    1
    2
         Adverse event, non-fatal
    -
    -
    -
    1
         Lack of efficacy
    -
    -
    1
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 300 subjects who were enrolled, 202 were randomised and treated. Reason for not being randomised: adverse event (1), subject withdrew consent (2), poor/non-compliance (1), subject no longer meets study criteria (92) and administrative reason by sponsor (2).

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Treatment-naive: DCV 3DAA
    Reporting group description
    		 Subjects (treatment naïve) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with placebo matched to ribavirin tablet orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Reporting group title
    Treatment-naive: DCV 3DAA + RBV
    Reporting group description
    		 Subjects (treatment naive) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with ribavirin 200 mg orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Reporting group title
    Treatment-experienced: DCV 3DAA
    Reporting group description
    		 Subjects (treatment experienced) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with placebo matched to ribavirin tablet orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Reporting group title
    Treatment-experienced: DCV 3DAA +RBV
    Reporting group description
    		 Subjects (treatment experienced) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with RIBAVIRIN 200 mg orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Reporting group values
    		 Treatment-naive: DCV 3DAA Treatment-naive: DCV 3DAA + RBV Treatment-experienced: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV Total
    Number of subjects
    		 57 55 45 45 202
    Age categorical
    Units: Subjects
        <65 years
    		 43 46 42 34 165
        >=65 years
    		 14 9 3 11 37
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.1 ( 9.03 ) 58.7 ( 6.55 ) 57.1 ( 8.35 ) 60 ( 6.24 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 20 13 18 69
        Male
    		 39 35 32 27 133

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Treatment-naive: DCV 3DAA
    Reporting group description
    		 Subjects (treatment naïve) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with placebo matched to ribavirin tablet orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Reporting group title
    Treatment-naive: DCV 3DAA + RBV
    Reporting group description
    		 Subjects (treatment naive) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with ribavirin 200 mg orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Reporting group title
    Treatment-experienced: DCV 3DAA
    Reporting group description
    		 Subjects (treatment experienced) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with placebo matched to ribavirin tablet orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Reporting group title
    Treatment-experienced: DCV 3DAA +RBV
    Reporting group description
    		 Subjects (treatment experienced) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with RIBAVIRIN 200 mg orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Primary: Percentage of Subjects in Treatment-naive Cohort With Sustained Virologic Response at Follow-up Week 12 (SVR12)

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    End point title
    		 Percentage of Subjects in Treatment-naive Cohort With Sustained Virologic Response at Follow-up Week 12 (SVR12) [1] [2]
    End point description
    SVR12 was defined as hepatitis C virus (HCV) RNA levels <lower limit of quantitation (LLOQ), target detected or target not detected at follow-up week 12. The LLOQ was 25 international unit per milliliter. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. The analysis was performed on all treated subjects using as-randomized treatment arm, the numerator was based on subjects meeting the response criteria and denominator based on all treated subjects. Missing values were imputed using Next Value Carried Backwards (NVCB) approach, i.e., missing HCV RNA in the follow-up Week 12 window was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 HCV RNA window.
    End point type
    Primary
    End point timeframe
    Follow-up week 12
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Only descriptive data was planned to be analysed for this endpoint.
    [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: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Treatment-naive: DCV 3DAA Treatment-naive: DCV 3DAA + RBV
    Number of subjects analysed
    57
    55
    Units: Percentage of subject
        number (confidence interval 97.5%)
    93 (85.4 to 100)
    100 (92.3 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects in Treatment-Experienced Cohort With Sustained Virologic Response at Follow-up Week 12 (SVR12)

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    End point title
    		 Percentage of Subjects in Treatment-Experienced Cohort With Sustained Virologic Response at Follow-up Week 12 (SVR12) [3]
    End point description
    SVR12 was defined as hepatitis C virus (HCV) RNA levels <lower limit of quantitation (LLOQ), target detected or target not detected at follow-up week 12. The LLOQ was 25 international unit per milliliter. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. The analysis was performed on all treated subjects using as-randomized treatment arm, the numerator was based on subjects meeting the response criteria and denominator based on all treated subjects. Missing values were imputed using Next Value Carried Backwards (NVCB) approach, i.e., missing HCV RNA in the follow-up Week 12 window was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 HCV RNA window.
    End point type
    Secondary
    End point timeframe
    Follow-up week 12
    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: The endpoint was planned to evaluate for the specified arm only.
    End point values
    		 Treatment-experienced: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV
    Number of subjects analysed
    45
    45
    Units: Percentage of subjects
        number (confidence interval 97.5%)
    86.7 (75.3 to 98)
    93.3 (85 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Hepatitis C Virus (HCV) RNA Levels Below Lower Limit of Quantitation (LLOQ) Target Detected (TD) or Target Not Detected (TND)

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    End point title
    		 Percentage of Subjects With Hepatitis C Virus (HCV) RNA Levels Below Lower Limit of Quantitation (LLOQ) Target Detected (TD) or Target Not Detected (TND)
    End point description
    Subjects who achieved HCV RNA levels <LLOQ, TD or TND. The LLOQ was 25 international unit per milliliter. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. The analysis was performed in modified intent-to-treat population, the numerator was based on subjects meeting the response criteria and denominator based on all treated subjects.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 4, 6, 8, 12; follow-up Week 4, 8, and 24
    End point values
    		 Treatment-naive: DCV 3DAA Treatment-naive: DCV 3DAA + RBV Treatment-experienced: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV
    Number of subjects analysed
    57
    55
    45
    45
    Units: Percentage of subjects
    number (not applicable)
        Week 1
    22.8
    25.5
    20
    17.8
        Week 2
    57.9
    67.3
    55.6
    68.9
        Week 4
    100
    98.2
    88.9
    97.8
        Week 6
    96.5
    98.2
    97.8
    100
        Week 8
    98.2
    98.2
    97.8
    95.6
        Week 12
    100
    100
    93.3
    88.9
        Follow-up week 4
    94.7
    98.2
    88.9
    91.1
        Follow-up week 8
    91.2
    89.1
    84.4
    91.1
        Follow-up week 24
    93
    100
    86.7
    91.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Hepatitis C Virus (HCV) RNA Levels Below Than Lower Limit of Quantitation (LLOQ) Target Not Detected (TND)

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    End point title
    		 Percentage of Subjects With Hepatitis C Virus (HCV) RNA Levels Below Than Lower Limit of Quantitation (LLOQ) Target Not Detected (TND)
    End point description
    Subjects who achieved HCV RNA levels <LLOQ, TND. The LLOQ was 25 international unit per milliliter. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. The analysis was performed in modified intent-to-treat population, the numerator was based on subjects meeting the response criteria and denominator based on all treated subjects.
    End point type
    Secondary
    End point timeframe
    Week 1, 2, 4, 6, 8, 12; follow-up Week 4, 8, 12 and 24
    End point values
    		 Treatment-naive: DCV 3DAA Treatment-naive: DCV 3DAA + RBV Treatment-experienced: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV
    Number of subjects analysed
    57
    55
    45
    45
    Units: Percentage of subjects
    number (not applicable)
        Week 1
    1.8
    7.3
    2.2
    2.2
        Week 2
    24.6
    29.1
    20
    17.8
        Week 4
    68.4
    80
    57.8
    68.9
        Week 6
    87.7
    94.5
    88.9
    97.8
        Week 8
    96.5
    94.5
    93.3
    84.4
        Week 12
    100
    98.2
    93.3
    88.9
        Follow-up week 4
    93
    98.2
    88.9
    91.1
        Follow-up week 8
    91.2
    89.1
    84.4
    91.1
        Follow-up week 12
    93
    98.2
    86.7
    93.3
        Follow-up week 24
    93
    100
    86.7
    91.1
    No statistical analyses for this end point

    Secondary: Number of Subjects with On-Treatment Serious Adverse Events (SAEs) and Discontinuations due to Adverse Events (AEs)

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    End point title
    		 Number of Subjects with On-Treatment Serious Adverse Events (SAEs) and Discontinuations due to Adverse Events (AEs)
    End point description
    An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a subject or clinical investigation subject administered an investigational (medicinal) product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization. The analysis was performed on all subjects who received at least 1 dose of study therapy.
    End point type
    Secondary
    End point timeframe
    Baseline through the last dose of study therapy plus 7 days
    End point values
    		 Treatment-naive: DCV 3DAA Treatment-naive: DCV 3DAA + RBV Treatment-experienced: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV
    Number of subjects analysed
    57
    55
    45
    45
    Units: Subjects
        SAEs
    1
    5
    1
    2
        Discontinuation due to AEs
    0
    2
    0
    2
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Anemia on Treatment

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    End point title
    		 Percentage of Subjects With Anemia on Treatment
    End point description
    Anemia was defined as hemoglobin level less than 10 gram per deciliter (g/dL) on treatment for subjects who had hemoglobin level equal to or above 10 g/dL at baseline. The analysis was performed on all subjects who received at least 1 dose of study therapy.
    End point type
    Secondary
    End point timeframe
    Baseline through the last dose of study therapy plus 7 days
    End point values
    		 Treatment-naive: DCV 3DAA Treatment-naive: DCV 3DAA + RBV Treatment-experienced: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV
    Number of subjects analysed
    57
    55
    45
    45
    Units: Percentage of subjects
        number (not applicable)
    0
    9.1
    0
    20
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects With Selected Treatment Emergent Grade 3 to 4 Laboratory Test Abnormalities
    End point description
    Laboratory tests with Division of AIDS Version 1.0 toxicity criteria were performed and assessed. Assessment were done for following: hemoglobin, leukocytes, neutrophils + bands, lymphocytes, platelet count, international normalized Ratio, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, creatinine and lipase. The analysis was performed on all subjects who received at least 1 dose of study therapy.
    End point type
    Secondary
    End point timeframe
    Baseline through the last dose of study therapy plus 7 days
    End point values
    		 Treatment-naive: DCV 3DAA Treatment-naive: DCV 3DAA + RBV Treatment-experienced: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV
    Number of subjects analysed
    57
    55
    45
    45
    Units: Subjects
        Hemoglobin
    0
    2
    0
    3
        Leukocytes
    0
    1
    0
    0
        Neutrophils +Bands
    1
    0
    0
    1
        Lymphocytes
    0
    0
    1
    3
        Platelets count
    1
    1
    1
    1
        International Normalized Ratio
    0
    0
    0
    0
        Alanine aminotransferase
    2
    0
    1
    1
        Aspartate aminotransferase
    1
    0
    1
    1
        Total bilirubin
    0
    2
    0
    1
        Alkaline phosphatase
    0
    0
    0
    0
        Albumin
    0
    0
    0
    0
        Creatinine, enzymatic
    0
    0
    0
    0
        Lipase
    4
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b

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    End point title
    		 Percentage of Subjects With Sustained Virologic Response at Follow-up Week 12 (SVR12) Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b
    End point description
    Subjects categorized into two genotype subtypes that were assessed for SVR12 defined as HCV RNA levels <LLOQ, TD or TND at follow-up week 12. The LLOQ was 25 international unit per milliliter. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. The analysis was performed on treated subjects using as-randomized treatment arm, the numerator was based on subjects meeting the response criteria and denominator based on all treated subjects. Here, ‘n’ signifies number of subjects evaluable at the specified subgroup. Missing values were imputed using NVCB approach.
    End point type
    Secondary
    End point timeframe
    Follow-up week 12
    End point values
    		 Treatment-naive: DCV 3DAA Treatment-naive: DCV 3DAA + RBV Treatment-experienced: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV
    Number of subjects analysed
    57
    55
    45
    45
    Units: Percentage of subjects
    number (confidence interval 95%)
        Genotype-1A (n=40, 39, 35, 35)
    90 (80.7 to 99.3)
    100 (91 to 100)
    85.7 (74.1 to 97.3)
    91.4 (82.2 to 100)
        Genotype-1B (n=17, 15, 10, 10)
    100 (80.5 to 100)
    100 (78.2 to 100)
    90 (55.5 to 99.7)
    100 (69.2 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphism (SNP) status (CC Genotype or Non-CC Genotype)

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    End point title
    		 Percentage of Subjects With SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphism (SNP) status (CC Genotype or Non-CC Genotype)
    End point description
    Subjects categorized into two genotypes based on SNP in the IL28B gene were assessed for SVR12 defined as HCV RNA levels <LLOQ, TD or TND at follow-up week 12. The LLOQ was 25 IU/mL. Here ‘’99999’’ signifies not available as data for the specified time point for this endpoint was not analyzed. The analysis was performed on treated subjects using as-randomized treatment arm, the numerator was based on subjects meeting the response criteria and denominator based on all treated subjects. Here, ‘n’ signifies number of subjects evaluable for the specified category and ‘99999’ signifies not applicable (NA) as no subject was analysed for that specified category. Missing values were imputed using NVCB approach.
    End point type
    Secondary
    End point timeframe
    Follow-up week 12
    End point values
    		 Treatment-naive: DCV 3DAA Treatment-naive: DCV 3DAA + RBV Treatment-experienced: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV
    Number of subjects analysed
    57
    55
    45
    45
    Units: Percentage of subjects
    number (confidence interval 95%)
        CC Genotype (n=13, 18, 15, 09)
    84.6 (54.6 to 98.1)
    100 (81.5 to 100)
    86.7 (59.5 to 98.3)
    100 (66.4 to 100)
        Non-CC Genotype (n=43, 37, 30, 36)
    95.3 (84.2 to 99.4)
    100 (90.5 to 100)
    86.7 (74.5 to 98.8)
    91.7 (82.6 to 100)
        Not reported (n=1, 0, 0, 0)
    100 (2.5 to 100)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through the last dose of study therapy plus 7 days
    Adverse event reporting additional description
    On-treatment period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Treatment-naive: DCV 3DAA
    Reporting group description
    		 Subjects (treatment naïve) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with placebo matched to ribavirin tablet orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Reporting group title
    Treatment-experienced: DCV 3DAA +RBV
    Reporting group description
    		 Subjects (treatment experienced) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with RIBAVIRIN 200 mg orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Reporting group title
    Treatment-experienced: DCV 3DAA
    Reporting group description
    		 Subjects (treatment experienced) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with placebo matched to ribavirin tablet orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Reporting group title
    Treatment-naive: DCV 3DAA + RBV
    Reporting group description
    		 Subjects (treatment naive) received a fixed dose combination of daclatasvir 30 mg tablet, asunaprevir 200 mg tablets and beclabuvir 75 mg tablets orally, twice daily up to 12 weeks along with ribavirin 200 mg orally twice daily in a body weight stratified dose range of 1000–1200 mg per day (total dose of 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing >=75 kg). After 12 weeks of drug therapy, subjects were followed-up for 24 weeks.

    Serious adverse events
    		 Treatment-naive: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV Treatment-experienced: DCV 3DAA Treatment-naive: DCV 3DAA + RBV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 57 (1.75%)
    2 / 45 (4.44%)
    1 / 45 (2.22%)
    5 / 55 (9.09%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Meniscus injury
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast hyperplasia
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 45 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Drug-Induced liver injury
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    0 / 45 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 57 (1.75%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 45 (0.00%)
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment-naive: DCV 3DAA Treatment-experienced: DCV 3DAA +RBV Treatment-experienced: DCV 3DAA Treatment-naive: DCV 3DAA + RBV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 57 (59.65%)
    40 / 45 (88.89%)
    22 / 45 (48.89%)
    44 / 55 (80.00%)
    Investigations
    Haemoglobin decreased
         subjects affected / exposed
    0 / 57 (0.00%)
    4 / 45 (8.89%)
    0 / 45 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    4
    0
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 57 (0.00%)
    6 / 45 (13.33%)
    0 / 45 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    0
    6
    0
    2
    Headache
         subjects affected / exposed
    9 / 57 (15.79%)
    14 / 45 (31.11%)
    8 / 45 (17.78%)
    9 / 55 (16.36%)
         occurrences all number
    10
    16
    9
    9
    Lethargy
         subjects affected / exposed
    0 / 57 (0.00%)
    3 / 45 (6.67%)
    2 / 45 (4.44%)
    2 / 55 (3.64%)
         occurrences all number
    0
    3
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 57 (0.00%)
    8 / 45 (17.78%)
    0 / 45 (0.00%)
    6 / 55 (10.91%)
         occurrences all number
    0
    8
    0
    6
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 57 (5.26%)
    4 / 45 (8.89%)
    0 / 45 (0.00%)
    4 / 55 (7.27%)
         occurrences all number
    3
    4
    0
    4
    Fatigue
         subjects affected / exposed
    6 / 57 (10.53%)
    12 / 45 (26.67%)
    6 / 45 (13.33%)
    16 / 55 (29.09%)
         occurrences all number
    6
    14
    6
    16
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 45 (2.22%)
    0 / 45 (0.00%)
    3 / 55 (5.45%)
         occurrences all number
    1
    1
    0
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 57 (1.75%)
    5 / 45 (11.11%)
    2 / 45 (4.44%)
    1 / 55 (1.82%)
         occurrences all number
    1
    7
    2
    1
    Diarrhoea
         subjects affected / exposed
    7 / 57 (12.28%)
    3 / 45 (6.67%)
    6 / 45 (13.33%)
    6 / 55 (10.91%)
         occurrences all number
    9
    3
    7
    6
    Dyspepsia
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 45 (6.67%)
    2 / 45 (4.44%)
    1 / 55 (1.82%)
         occurrences all number
    2
    3
    3
    1
    Flatulence
         subjects affected / exposed
    3 / 57 (5.26%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    3
    0
    0
    2
    Nausea
         subjects affected / exposed
    11 / 57 (19.30%)
    7 / 45 (15.56%)
    3 / 45 (6.67%)
    10 / 55 (18.18%)
         occurrences all number
    11
    7
    3
    10
    Vomiting
         subjects affected / exposed
    4 / 57 (7.02%)
    1 / 45 (2.22%)
    0 / 45 (0.00%)
    4 / 55 (7.27%)
         occurrences all number
    4
    1
    0
    4
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 57 (1.75%)
    5 / 45 (11.11%)
    0 / 45 (0.00%)
    4 / 55 (7.27%)
         occurrences all number
    1
    5
    0
    5
    Dyspnoea
         subjects affected / exposed
    0 / 57 (0.00%)
    4 / 45 (8.89%)
    1 / 45 (2.22%)
    6 / 55 (10.91%)
         occurrences all number
    0
    4
    1
    6
    Dyspnoea exertional
         subjects affected / exposed
    1 / 57 (1.75%)
    5 / 45 (11.11%)
    0 / 45 (0.00%)
    2 / 55 (3.64%)
         occurrences all number
    1
    5
    0
    2
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 57 (0.00%)
    4 / 45 (8.89%)
    2 / 45 (4.44%)
    2 / 55 (3.64%)
         occurrences all number
    0
    4
    2
    2
    Dry skin
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 45 (6.67%)
    1 / 45 (2.22%)
    5 / 55 (9.09%)
         occurrences all number
    1
    3
    1
    5
    Pruritus
         subjects affected / exposed
    2 / 57 (3.51%)
    11 / 45 (24.44%)
    4 / 45 (8.89%)
    4 / 55 (7.27%)
         occurrences all number
    2
    11
    4
    4
    Rash
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 45 (6.67%)
    2 / 45 (4.44%)
    6 / 55 (10.91%)
         occurrences all number
    1
    3
    2
    7
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 45 (6.67%)
    1 / 45 (2.22%)
    0 / 55 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Insomnia
         subjects affected / exposed
    3 / 57 (5.26%)
    7 / 45 (15.56%)
    3 / 45 (6.67%)
    8 / 55 (14.55%)
         occurrences all number
    3
    8
    3
    8
    Irritability
         subjects affected / exposed
    0 / 57 (0.00%)
    4 / 45 (8.89%)
    1 / 45 (2.22%)
    3 / 55 (5.45%)
         occurrences all number
    0
    4
    1
    3
    Sleep disorder
         subjects affected / exposed
    1 / 57 (1.75%)
    3 / 45 (6.67%)
    0 / 45 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    1
    3
    0
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 57 (0.00%)
    1 / 45 (2.22%)
    3 / 45 (6.67%)
    0 / 55 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 57 (7.02%)
    0 / 45 (0.00%)
    0 / 45 (0.00%)
    0 / 55 (0.00%)
         occurrences all number
    4
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 45 (0.00%)
    2 / 45 (4.44%)
    3 / 55 (5.45%)
         occurrences all number
    0
    0
    2
    3
    Rhinitis
         subjects affected / exposed
    1 / 57 (1.75%)
    1 / 45 (2.22%)
    1 / 45 (2.22%)
    3 / 55 (5.45%)
         occurrences all number
    1
    1
    1
    3
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 57 (5.26%)
    1 / 45 (2.22%)
    4 / 45 (8.89%)
    1 / 55 (1.82%)
         occurrences all number
    4
    1
    4
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Oct 2013
    Permitted the collection and storage of blood samples for use in future exploratory pharmacogenetic research.
    21 Apr 2014
    An interim analysis was added after all subjects complete post-treatment Week 4 in order to support pharmacokinetic modeling and simulations for exposure-response analysis.
    24 Jun 2014
    Historical threshold of sustained virologic response for treatment of chronic hepatitis C virus infection was updated.

    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
    For support, Contact us.
    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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