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    Clinical Trial Results:
    A Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731 + Entecavir vs Entecavir Alone for the Treatment of Viremic, HBeAg-positive Patients with Chronic Hepatitis B

    Summary
    EudraCT number
    		 2018-002042-36
    Trial protocol
    		 GB  
    Global end of trial date
    21 Jun 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Jan 2021
    First version publication date
    06 Jan 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ABI-H0731-202
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03577171
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Assembly Biosciences
    Sponsor organisation address
    11711 North Meridian Street, Suite 310, Carmel, Indiana, United States, 46032
    Public contact
    Linda Baher, Sr. Director, Clinical Operations, Assembly Biosciences, 1 415-521-3808, clinicaltrials@assemblybio.com
    Scientific contact
    Linda Baher, Sr. Director, Clinical Operations, Assembly Biosciences, 1 415-521-3808, clinicaltrials@assemblybio.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
    21 Jun 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jun 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to determine if ABI-H0731 given in combination with a standard of care (SOC) entecavir (ETV) is safe and effective in participants with chronic hepatitis B infection (cHBV).
    Protection of trial subjects
    This study will be conducted in compliance with IRB/IEC and International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines; Title 21 Part 56 of the US Code of Federal Regulations (CFR) relating to IRBs/IECs and GCP as described in the US FDA CFR (21 CFR § 50, 56, 312; applicable ICH guidelines regarding clinical safety data management (E2A, E2B(R3)); European Community directives 2001/20, 2001/83, 2003/94 and 2005/28 as enacted into local law, and with ICH guidelines regarding scientific integrity (E4, E8, E9, and E10). In addition, this study will adhere to all local regulatory requirements, and requirements for data protection.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Jun 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    New Zealand: 1
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Hong Kong: 5
    Country: Number of subjects enrolled
    United States: 14
    Country: Number of subjects enrolled
    United Kingdom: 2
    Worldwide total number of subjects
    25
    EEA total number of subjects
    2
    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)
    24
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at 13 sites worldwide (8 sites in the US, 1 site in Hong Kong, 2 sites in Canada, 1 site in the United Kingdom, and 1 site in New Zealand).

    Pre-assignment
    Screening details
    		 There was a screening period of up to 45 days.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ABI-H0731 + SOC ETV
    Arm description
    		 Participants with chronic hepatitis B infection (cHBV) who are currently not being treated will receive ABI-H0731 along with standard of care (SOC) entecavir (ETV) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABI-H0731
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants will receive 300mg QD of ABI-H0731 tablets orally.

    Investigational medicinal product name
    Entecavir (ETV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants will receive standard of care (SOC) ETV (0.5 mg QD) orally as per approved package insert.

    Arm title
    		 Placebo + SOC ETV
    Arm description
    		 Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Entecavir (ETV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.

    Investigational medicinal product name
    Placebo Oral Tablet
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants will receive matching QD placebo tablets orally.

    Number of subjects in period 1
    		ABI-H0731 + SOC ETV Placebo + SOC ETV
    Started
    13
    12
    Completed
    13
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ABI-H0731 + SOC ETV
    Reporting group description
    		 Participants with chronic hepatitis B infection (cHBV) who are currently not being treated will receive ABI-H0731 along with standard of care (SOC) entecavir (ETV) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.

    Reporting group title
    Placebo + SOC ETV
    Reporting group description
    		 Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.

    Reporting group values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV Total
    Number of subjects
    		 13 12 25
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.7 ± 14.13 34.1 ± 11.39 -
    Gender categorical
    Units: Subjects
        Female
    		 10 7 17
        Male
    		 3 5 8
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0
        Not Hispanic or Latino
    		 13 12 25
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 13 11 24
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 1 1
        White
    		 0 0 0
        More than one race
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    ABI-H0731 + SOC ETV
    Reporting group description
    		 Participants with chronic hepatitis B infection (cHBV) who are currently not being treated will receive ABI-H0731 along with standard of care (SOC) entecavir (ETV) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.

    Reporting group title
    Placebo + SOC ETV
    Reporting group description
    		 Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.

    Primary: Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV

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    End point title
    		 Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV
    End point description
    Hepatitis B virus (HBV) DNA was measured using COBAS TaqMan Version 2.0. The lower limit of quantitation (LLOQ) was 20 IU/mL and the limit of detection (LOD) was 10 IU/mL.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12, and Week 24
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    13
    12
    Units: Log10 International Units (IU)
    arithmetic mean (standard deviation)
        Baseline
    7.91 ± 0.890
    8.03 ± 0.999
        Change from Baseline at Week 12
    -4.45 ± 1.027
    -3.30 ± 1.182
        Change from Baseline at Week 24
    -5.33 ± 1.594
    -4.20 ± 0.976
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Statistical Analysis 1 for Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV. Least Squares (LS) Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 12.
    Comparison groups
    ABI-H0731 + SOC ETV v Placebo + SOC ETV
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0077
    Method
    		 Repeated measures analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.154
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.986
         upper limit
    		 -0.322
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Statistical Analysis 2 for Change in Mean log10 HBV DNA From Baseline (Day 1) to Week 12 or Week 24 on ABI H0731 + SOC ETV as Compared to Placebo + SOC ETV. Least Squares Mean Difference ABI-H0731 + SOC ETV minus Placebo + SOC ETV at Week 24.
    Comparison groups
    Placebo + SOC ETV v ABI-H0731 + SOC ETV
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0084
    Method
    		 Repeated measures analysis
    Parameter type
    		 LS Mean Difference
    Point estimate
    -1.141
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.973
         upper limit
    		 -0.309

    Secondary: Number of Participants One or More Adverse Events

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    End point title
    		 Number of Participants One or More Adverse Events
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Follow-up (maximum up to Week 36)
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    13
    12
    Units: Participants
    7
    5
    No statistical analyses for this end point

    Secondary: Number of Participants With Premature Study Discontinuation

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    End point title
    		 Number of Participants With Premature Study Discontinuation
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Follow-up (maximum up to Week 36)
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    13
    12
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With One or More Abnormal Safety Laboratory Result

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    End point title
    		 Number of Participants With One or More Abnormal Safety Laboratory Result
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Week 36
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    13
    12
    Units: Participants
    8
    10
    No statistical analyses for this end point

    Secondary: Number of Participants With a Clinically-significant Electrocardiogram Abnormality

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    End point title
    		 Number of Participants With a Clinically-significant Electrocardiogram Abnormality
    End point description
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    13
    12
    Units: Participants
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV

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    End point title
    		 Number of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Have Normal ALT at Week 24 on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    4 [1]
    4 [2]
    Units: Participants
    4
    2
    Notes
    [1] - Participants in the ITT population with abnormal ALT at Baseline.
    [2] - Participants in the ITT population with abnormal ALT at Baseline.
    No statistical analyses for this end point

    Secondary: Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV

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    End point title
    		 Number of Participants With a Decline in Viral DNA to Below Limit of Quantitation on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
    End point description
    HBV DNA was measured using COBAS TaqMan Version 2.0. The LLOQ was 20 IU/mL and the LOD was 10 IU/mL. The number of participants with HBV DNA below the limit of quantitation (<20 IU/mL) and target detected (≥10 IU/mL) was assessed.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    13
    12
    Units: Participants
        Baseline
    0
    0
        Week 2
    0
    0
        Week 4
    0
    0
        Week 8
    1
    0
        Week 12
    1
    0
        Week 16
    2
    0
        Week 20
    1
    1
        Week 24
    3
    1
    No statistical analyses for this end point

    Secondary: Median Time to Viral Suppression, Defined as HBV DNA <20 IU/mL, on ABI-H0731 + ETV as Compared to Placebo + ETV

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    End point title
    		 Median Time to Viral Suppression, Defined as HBV DNA <20 IU/mL, on ABI-H0731 + ETV as Compared to Placebo + ETV
    End point description
    Median time to viral suppression will be calculated and evaluated between participants on ABI-H0731 + ETV as compared to placebo + ETV.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 8, 12, 16, 20, and 24
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    0 [3]
    0 [4]
    Units: Hours
        median (full range (min-max))
    ( to )
    ( to )
    Notes
    [3] - Analysis of this outcome measure was not performed because of insufficient data.
    [4] - Analysis of this outcome measure was not performed because of insufficient data.
    No statistical analyses for this end point

    Secondary: Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV

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    End point title
    		 Number of Participants With Emergence of Resistant HBV Variants on ABI-H0731 + SOC ETV as Compared to Placebo + SOC ETV
    End point description
    Emergence of a resistant HBV variant was defined as an increase of ≥1 log10 IU/mL from the nadir in HBV DNA.
    End point type
    Secondary
    End point timeframe
    Up to Week 36
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    13
    12
    Units: Participants
        Emergence of resistant HBV variants
    1
    1
        No emergence of resistant HBV variants
    12
    11
    No statistical analyses for this end point

    Secondary: Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy

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    End point title
    		 Trough Levels of ABI-H0731 on ABI-H0731 + SOC ETV Therapy [5]
    End point description
    End point type
    Secondary
    End point timeframe
    Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
    Notes
    [5] - 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: Analysis was only planned for the ABI-H0731 arm.
    End point values
    		 ABI-H0731 + SOC ETV
    Number of subjects analysed
    13
    Units: ng/mL
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    0 ± 0
        Week 2
    1480 ± 458
        Week 4
    1290 ± 434
        Week 12
    1270 ± 413
        Week 24
    1470 ± 547
    No statistical analyses for this end point

    Secondary: Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy

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    End point title
    		 Trough Levels of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
    End point description
    End point type
    Secondary
    End point timeframe
    Before dosing at Baseline (Day 1), Weeks 2, 4, 12, and 24
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    13
    12
    Units: ng/mL
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    0.00325 ± 0.0113
    0 ± 0
        Week 2
    0.432 ± 0.126
    0.497 ± 0.473
        Week 4
    0.419 ± 0.119
    0.618 ± 0.736
        Week 12
    0.378 ± 0.149
    0.666 ± 0.766
        Week 24
    0.411 ± 0.143
    0.408 ± 0.131
    No statistical analyses for this end point

    Secondary: Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + ETV Therapy

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    End point title
    		 Trough to Peak Ratios of ABI-H0731 on ABI-H0731 + ETV Therapy [6]
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 12, and 24
    Notes
    [6] - 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: Analysis was only planned for the ABI-H0731 arm.
    End point values
    		 ABI-H0731 + SOC ETV
    Number of subjects analysed
    0 [7]
    Units: Ratio
        arithmetic mean (standard deviation)
    ±
    Notes
    [7] - Trough to peak ratios were not calculated due to an insufficient # of optional peak exposure samples
    No statistical analyses for this end point

    Secondary: Trough to Peak Ratios of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy

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    End point title
    		 Trough to Peak Ratios of ETV on ABI-H0731 + ETV Therapy as Compared With Placebo + ETV Therapy
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 2, 4, 12, 24, and 28
    End point values
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: Ratio
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [8] - Trough to peak ratios were not calculated due to an insufficient # of optional peak exposure samples
    [9] - Trough to peak ratios were not calculated due to an insufficient # of optional peak exposure samples
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 36
    Adverse event reporting additional description
    Safety population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    ABI-H0731 + SOC ETV
    Reporting group description
    		 Participants with chronic hepatitis B infection (cHBV) who are currently not being treated will receive ABI-H0731 along with standard of care (SOC) entecavir (ETV) tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to continue open-label ABI-H0731 for up to an additional year if necessary.

    Reporting group title
    Placebo + SOC ETV
    Reporting group description
    		 Participants with cHBV who are currently not being treated will receive matching placebo along with SOC ETV tablets orally for 24 weeks. Eligible participants may enter a separate extension study after Week 24 to start treatment on open-label ABI-H0731 for up to a year if necessary.

    Serious adverse events
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 ABI-H0731 + SOC ETV Placebo + SOC ETV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 13 (53.85%)
    5 / 12 (41.67%)
    Investigations
    Alanine aminotransferase increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 13 (7.69%)
    2 / 12 (16.67%)
         occurrences all number
    1
    2
    Electrocardiogram T wave abnormal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    1
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    General disorders and administration site conditions
    Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain lower
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Abdominal pain upper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Epistaxis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Acne
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Pruritus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 13 (15.38%)
    0 / 12 (0.00%)
         occurrences all number
    2
    0
    Skin irritation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Stress
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Infections and infestations
    Folliculitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 13 (7.69%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 13 (7.69%)
    1 / 12 (8.33%)
         occurrences all number
    1
    2
    Viral infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 13 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jun 2018
    Protocol Amendment 1 - Summary of Changes: - Clarified inclusion criteria - Revised the prohibited concomitant therapy section - Revised Subjects with Alanine Aminotransferase Elevations section - Corrections and revisions to the Schedule of Assessments - Administrative changes
    30 Jul 2018
    Protocol Version 2.1 (UK) - Summary of Changes: - Revised Subjects with Alanine Aminotransferase Elevations section - Revised Schedule of Assessments - Clarified Blinding section - Added Section 6.3.3.1: Unblinding for Emergency Situations

    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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