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    Clinical Trial Results:
    A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents With Acute Hepatitis C Virus (HCV) Infection

    Summary
    EudraCT number
    2020-005777-27
    Trial protocol
    DE   ES   AT   FR   IT  
    Global end of trial date
    17 Sep 2024

    Results information
    Results version number
    v1(current)
    This version publication date
    23 Mar 2025
    First version publication date
    23 Mar 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M20-350
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04903626
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co. KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6 4UB
    Public contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.com
    Scientific contact
    Global Medical Services, AbbVie, 001 8006339110, abbvieclinicaltrials@abbvie.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
    17 Sep 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of this study are to assess the safety and efficacy of GLE/PIB 8-week treatment in adults and adolescents with confirmed acute HCV infection.
    Protection of trial subjects
    Subject and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    24 Aug 2021
    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
    Australia: 2
    Country: Number of subjects enrolled
    Austria: 7
    Country: Number of subjects enrolled
    Canada: 13
    Country: Number of subjects enrolled
    France: 18
    Country: Number of subjects enrolled
    Germany: 72
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Spain: 89
    Country: Number of subjects enrolled
    United States: 68
    Worldwide total number of subjects
    286
    EEA total number of subjects
    203
    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)
    270
    From 65 to 84 years
    16
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This study includes a 30-day screening period.

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

    Arms
    Arm title
    Glecaprevir/Pibrentasvir
    Arm description
    Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Glecaprevir/Pibrentasvir
    Investigational medicinal product code
    Other name
    ABT-493/ABT-530, Maviret
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants treated once daily with oral tablets of glecaprevir/pibrentasvir 300 mg/120 mg once daily (QD) for 8 weeks.

    Number of subjects in period 1
    Glecaprevir/Pibrentasvir
    Started
    286
    Completed
    278
    Not completed
    8
         Other, not specified
    1
         Lost to follow-up
    6
         Withdrawal by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Glecaprevir/Pibrentasvir
    Reporting group description
    Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.

    Reporting group values
    Glecaprevir/Pibrentasvir Total
    Number of subjects
    286 286
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    43.7 ( 11.71 ) -
    Gender categorical
    Units: Subjects
        Female
    31 31
        Male
    255 255
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    76 76
        Not Hispanic or Latino
    210 210
    Race
    Units: Subjects
        White
    246 246
        Black or African American
    30 30
        Asian
    7 7
        Multiple
    3 3

    End points

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    End points reporting groups
    Reporting group title
    Glecaprevir/Pibrentasvir
    Reporting group description
    Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.

    Primary: Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population

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    End point title
    Percentage of Participants Achieving Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in the Intention-to-Treat (ITT) Population [1]
    End point description
    SVR12 is defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study treatment. Efficacy was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants achieving SVR12 was greater than 90.5%. ITT Population: all enrolled participants who received at least 1 dose of study treatment.
    End point type
    Primary
    End point timeframe
    12 weeks after last dose of study treatment (Week 20)
    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: Descriptive statistics per protocol are presented in the data table.
    End point values
    Glecaprevir/Pibrentasvir
    Number of subjects analysed
    286
    Units: percentage of participants
        number (confidence interval 95%)
    96.2 (93.2 to 97.8)
    No statistical analyses for this end point

    Secondary: Percentage of Participants Achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) Population

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    End point title
    Percentage of Participants Achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) Population
    End point description
    SVR12 is defined as the HCV RNA level < LLOQ 12 weeks after the last dose of study treatment. Efficacy was demonstrated if the lower bound of the 2-sided 95% CI for the percentage of participants achieving SVR12 was greater than 92.7%. This efficacy analysis was performed only if success was demonstrated for the primary efficacy analysis, following a fixed-sequence testing procedure. mITT-VF population: all enrolled participants who received at least one dose of study treatment, excluding those who did not achieve SVR12 for reasons other than virologic failure (i.e., those with HCV reinfection, those who did not achieve SVR12 due to early premature discontinuation of study treatment, and those who were missing HCV RNA data in the SVR12 window after backward imputation).
    End point type
    Secondary
    End point timeframe
    12 weeks after last dose of study treatment (Week 20)
    End point values
    Glecaprevir/Pibrentasvir
    Number of subjects analysed
    275
    Units: percentage of participants
        number (confidence interval 95%)
    100 (98.6 to 100.0)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With On-Treatment Virologic Failure in the ITT Population

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    End point title
    Percentage of Participants With On-Treatment Virologic Failure in the ITT Population
    End point description
    On-treatment virologic failure is defined as confirmed increase in HCV RNA of > 1 log^10 IU/mL above the lowest post-baseline value during treatment, confirmed HCV RNA >= 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA >= LLOQ at the end of treatment (EOT) with at least 6 weeks of treatment. ITT Population: all enrolled participants who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    up to Week 8
    End point values
    Glecaprevir/Pibrentasvir
    Number of subjects analysed
    286
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 1.3)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Post-Treatment (PT) Relapse in the ITT Population

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    End point title
    Percentage of Participants With Post-Treatment (PT) Relapse in the ITT Population
    End point description
    PT relapse is defined as confirmed HCV RNA >= LLOQ between the EOT and 12 weeks after the last dose of study treatment among participants who completed treatment as planned (study treatment duration >= 52 days) with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value, excluding cases of reinfection. ITT Population: all enrolled participants who received at least 1 dose of study treatment. Participants who completed treatment as planned with HCV RNA < LLOQ at the EOT and with at least 1 PT HCV RNA value.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks after the last dose of study treatment (Week 20)
    End point values
    Glecaprevir/Pibrentasvir
    Number of subjects analysed
    278
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0.0 to 1.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With PT Reinfection With HCV in the ITT Population

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    End point title
    Percentage of Participants With PT Reinfection With HCV in the ITT Population
    End point description
    PT reinfection is defined as confirmed HCV RNA >= LLOQ in the PT period in a participant who had HCV RNA < LLOQ at the final treatment visit, along with the PT detection of a different HCV genotype, subtype, or clade compared with baseline. ITT Population: all enrolled participants who received at least 1 dose of study treatment.
    End point type
    Secondary
    End point timeframe
    Up to 12 weeks after the last dose of study treatment (Week 20)
    End point values
    Glecaprevir/Pibrentasvir
    Number of subjects analysed
    286
    Units: percentage of participants
        number (confidence interval 95%)
    0.7 (0.2 to 2.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening (Day -30) through Post-treatment Week 12 (Week 20) or premature discontinuation.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Glecaprevir/Pibrentasvir
    Reporting group description
    Participants treated QD with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.

    Serious adverse events
    Glecaprevir/Pibrentasvir
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 286 (4.20%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    CRANIOFACIAL FRACTURE
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ANKLE FRACTURE
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ALCOHOL POISONING
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RIB FRACTURE
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    OVERDOSE
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ROAD TRAFFIC ACCIDENT
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    TOXICITY TO VARIOUS AGENTS
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    ENTEROCOLITIS
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ILEUS
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    RECTAL PERFORATION
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    PELVIC PAIN
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    SUBSTANCE-INDUCED PSYCHOTIC DISORDER
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    DRUG ABUSE
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    STAPHYLOCOCCAL INFECTION
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    SEPTIC EMBOLUS
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    PERIORBITAL CELLULITIS
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    MONKEYPOX
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    ABSCESS LIMB
         subjects affected / exposed
    2 / 286 (0.70%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    BACTERAEMIA
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    CELLULITIS
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    HYPOGLYCAEMIA
         subjects affected / exposed
    1 / 286 (0.35%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Glecaprevir/Pibrentasvir
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 286 (17.13%)
    General disorders and administration site conditions
    FATIGUE
         subjects affected / exposed
    19 / 286 (6.64%)
         occurrences all number
    19
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    18 / 286 (6.29%)
         occurrences all number
    18
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    15 / 286 (5.24%)
         occurrences all number
    17

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Apr 2021
    The purpose of this version is to correct minor clerical errors for consistency and edits for clarification throughout the protocol in addition to the following: - Modify and clarify eligibility criteria: - Total bilirubin parameter was removed as an eligibility criterion. - Addition of cholestatic liver disease such as primary biliary cholangitis and primary sclerosing cholangitis to list of examples of causes for liver disease. - Added an allowance for retesting for hemoglobin or calculated creatinine clearance if initial test is exclusionary. - Appendix D Activity Schedule – activity visits after Baseline are indicated only by week for clarity. - Section 6.1 - Clarified procedure for reporting pregnancy in a study subject. - The following modifications were made due to the COVID-19 pandemic: - Section 2.2 – noted the re-evaluation of the benefit and risks to subjects participating in the study. - Section 5.1 – added rescreening criteria for subjects who had a SARS-CoV-2 infection. - Section 5.4 – added COVID-19 pandemic-related vaccination guidance. - Section 5.5 – added information on COVID-19 pandemic-related mitigation strategies for discontinuation of subjects from the study. - Section 5.7 – included instructions that in the event the subject cannot pick up study drug onsite, refer to the Operations Manual for DTP shipment as needed and permitted by local regulations. - Section 5.9 – clarified that protocol deviations may include modifications due to COVID-19. - Section 8.2 – added information that AbbVie should be notified if any urgent safety measures are taken. - Section 9 – noted that remote monitoring may be employed as needed.
    02 Apr 2021
    (continued) - Appendix F - Operations Manual updated to include details on how to perform specific activities/procedures due to the COVID-19 pandemic, including use of phone/virtual visits, visits at alternative locations, or changes in frequency or timing of study procedures, DTP shipment of study drug and other study supplies as allowed, and supplemental eCRFs required in the event of a COVID-19 related SAE.
    23 Apr 2021
    The purpose of this version is to incorporate the following: - Modify eligibility criteria: - Contraception language was modified to widen the criteria in Section 5.2. - Modify clinical laboratory tests required: - Estimated glomerular filtration rate (Modification of Diet in Renal Disease equation) was added to the table of clinical laboratory tests in the Operations Manual (Appendix F).
    14 Oct 2021
    The purpose of this version is to correct minor clerical errors for consistency throughout the protocol in addition to the following: - Section 5.1: Removed weight restriction from eligibility criteria for adolescents 12 years and older. - Section 5.1: Modified text regarding who should undergo viral testing to rule out SARS-CoV-2 infection. - Section 5.1: Modified text for eligibility criteria regarding subjects who are enrolled in another clinical study. - Section 5.2: Clarified contraception requirements for males. - Operations Manual (Appendix F): Added text describing pregnancy testing. - Operations Manual (Appendix F): Replaced clinical laboratory name of Covance CLS with Labcorp Central Laboratory Services Limited Partnership. - Section 5.2: Clarified contraception requirements for females. - Section 6.1 and Operations Manual (Appendix F): Added text to define methods/contact information for reporting product complaints. - Operations Manual (Appendix F): Added text regarding storage of study drug. - Update information as per Administrative Change 1 dated 01 June 2021: - Modified text in the diagram in Section 4.1 of the Operations Manual (Appendix F). - Added a footnote to Table 1 in the Operations Manual (Appendix F).
    26 Aug 2022
    The purpose of this version is to correct minor clerical errors for consistency throughout the protocol in addition to the following: - Title page: Added Sponsor name for EU countries. - Section 5.1: Added text to Eligibility Criterion 5 to indicate that subjects must have quantifiable HCV RNA at Screening. - Section 5.1: Added bictegravir to Eligibility Criterion 9 as a permitted ART. - Section 5.1: Added instructions to Eligibility Criterion 11 for determining absence of decompensated cirrhosis. - Section 5.1: Added text to Eligibility Criterion 12 to indicate that subjects with indeterminate cirrhosis status must demonstrate absence of HCC. - Section 5.1: Edited text in Eligibility Criterion 23 to update the length of time that subjects must not have been treated with any investigational drug prior to the first dose of study drug. - Section 5.3: Added text to describe timing of discontinuation of prohibited medications and to indicate that concomitant use of certain medications is not allowed. - Section 5.7: Added text to describe handling of study drug upon completion or discontinuation from study treatment. - Section 5.7 and Section 6.1: Added text and table to define study drugs. - Section 6.1: Added text to describe collection of SAEs after 30 days following last dose of study drug or completion of study treatment. - Section 7.4: Added subgroups to the list for analysis of efficacy. -Section 11: Added definition of study start and updated definition of end-of-study. - Appendix B: Added text describing reporting responsibilities of the investigator. - Appendix C and Appendix F: Modified the list of protocol signatories. - Appendix F: Removed collection of respiratory rate. - Appendix F: Updated Section 1 contact information. - Appendix F: Added text to describe testing procedures for subjects with indeterminate cirrhosis status.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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