A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT02243280
Collaborator
(none)
174
Enrollment
11
Arms
18
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1 (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially planned in the protocol, it was not administered in any of the study arms.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Detailed Description

This study consisted of two independent parts: Part 1 was conducted first followed by Part 2. Part 1 enrolled participants who received ABT-493 and ABT-530 for 12 weeks; Part 2 enrolled participants who received ABT-493 and ABT-530 for 8 or 12 weeks. Participants who completed or prematurely discontinued the treatment period were followed for 24 weeks to monitor HCV RNA to evaluate efficacy and the emergence and persistence of viral variants.

Study Design

Study Type:
Interventional
Actual Enrollment :
174 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)
Study Start Date :
Aug 1, 2014
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

ArmIntervention/Treatment
Experimental: Arm A

ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis

Drug: ABT-493
Tablet
Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Experimental: Arm B

    ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Experimental: Arm C

    ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Experimental: Arm D

    ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Experimental: Arm E

    ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Experimental: Arm F

    ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Experimental: Arm G

    ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Experimental: Arm H

    ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Experimental: Arm I

    ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Experimental: Arm J

    ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Experimental: Arm K

    ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis

    Drug: ABT-493
    Tablet
    Other Names:
  • glecaprevir
  • Drug: ABT-530
    Tablet
    Other Names:
  • pibrentasvir
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment [12 weeks after the last actual dose of study drug]

      The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.

    Secondary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment [4 weeks after the last actual dose of study drug]

      The percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.

    2. Percentage of Participants With On-treatment Virologic Failure [Screening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment]

      The percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment), confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.

    3. Percentage of Participants With Post-treatment Relapse [From the end of treatment through 12 weeks after the last dose of study drug]

      Post-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Male or female between 18 and 70 years of age, inclusive, at time of screening

    2. Screening laboratory result indicating hepatitis C virus (HCV) GT1 (Study Parts 1 and

    1. or GT4, GT5, or GT6 (Study Part 2) infection
    1. Chronic HCV infection defined as one of the following:
    • Positive for anti-HCV antibody (Ab) or HCV RNA at least 6 months before screening, and positive for HCV RNA and anti-HCV Ab at the time of screening or

    • Positive for anti-HCV Ab and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of chronic HCV infection)

    1. Participant had to meet one of the following criteria:
    • Treatment-naïve: participant had never received treatment for HCV infection

    • Treatment-experienced: pegylated-interferon alpha-2a or alpha-2b and ribavirin (PR)-null responder (for Study Part 1) or PR-experienced (on-treatment failure or prior relapse) (for Study Part 2)

    1. Documented absence of cirrhosis (in Study Part 1 and in corresponding arms of Study Part 2), or compensated cirrhosis (in corresponding arms of Study Part 2, GT1 only), per local standard
    Exclusion Criteria:
    1. History of severe, life-threatening or other significant sensitivity to any drug

    2. Female who is pregnant, planning to become pregnant during the study or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study

    3. Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator

    4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)

    5. Hepatitis C virus (HCV) genotype performed during screening indicating co-infection with more than one HCV genotype

    6. Any cause of liver disease other than chronic HCV infection

    7. Participants with plasma HCV RNA load ≤ 10,000 international units (IU)/mL or unquantifiable or undetectable HCV RNA at screening

    8. Previous use of an HCV direct-acting antiviral agent (DAA)

    9. Consideration by the investigator, for any reason, that the participant was an unsuitable candidate to receive ABT-493, ABT-530, or RBV (RBV for cirrhotic subjects only)

    10. For participants in Study Part 2 who were enrolling with compensated cirrhosis: past clinical evidence of Child-Pugh B or C Classification (score of > 6) or clinical history of liver decompensation, including ascites (noted on physical exam), bleeding varices, use of beta-blockers for portal hypertension or ascites, or hepatic encephalopathy

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: Armen Asatryan, MD, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02243280
    Other Study ID Numbers:
    • M14-867
    • 2014-002925-36
    First Posted:
    Sep 17, 2014
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Jul 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment DetailSafety population: all participants who received at least 1 dose of study drug. Two participants assigned to Arm I received the incorrect dose of study drug throughout their participation in the study (ABT-493 200 mg QD instead of 300 mg) and are therefore included in Arm A instead of Arm I in the safety population.
    Arm/Group TitleArm AArm BArm CArm DArm EArm FArm GArm HArm IArm JArm K
    Arm/Group DescriptionABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
    Period Title: Enrolled
    STARTED4039000270034034
    COMPLETED4039000270034034
    NOT COMPLETED00000000000
    Period Title: Enrolled
    STARTED4239000270032034
    Completed Treatment4238000270032033
    COMPLETED4139000270031031
    NOT COMPLETED10000000103

    Baseline Characteristics

    Arm/Group TitleArm AArm BArm CArm DArm EArm FArm GArm HArm IArm JArm KTotal
    Arm/Group DescriptionABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosisTotal of all reporting groups
    Overall Participants4239000270032034174
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    52.4
    (10.01)
    52.5
    (10.41)
    58.9
    (5.47)
    55.0
    (11.13)
    53.5
    (10.34)
    54.1
    (9.98)
    Sex: Female, Male (Count of Participants)
    Female
    17
    40.5%
    21
    53.8%
    0
    NaN
    0
    NaN
    0
    NaN
    7
    25.9%
    0
    NaN
    0
    NaN
    16
    50%
    0
    NaN
    15
    44.1%
    76
    43.7%
    Male
    25
    59.5%
    18
    46.2%
    0
    NaN
    0
    NaN
    0
    NaN
    20
    74.1%
    0
    NaN
    0
    NaN
    16
    50%
    0
    NaN
    19
    55.9%
    98
    56.3%

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment
    DescriptionThe percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
    Time Frame12 weeks after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treat population: all participants who received at least 1 dose of study drug
    Arm/Group TitleArm AArm BArm CArm DArm EArm FArm GArm HArm IArm JArm K
    Arm/Group DescriptionABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
    Measure Participants4039000270034034
    Number (95% Confidence Interval) [percentage of participants]
    100
    238.1%
    97.4
    249.7%
    96.3
    Infinity
    100
    Infinity
    97.1
    Infinity
    2. Secondary Outcome
    TitlePercentage of Participants With Sustained Virologic Response (SVR) 4 Weeks Post-treatment
    DescriptionThe percentage of participants with sustained virologic response (plasma hepatitis C virus ribonucleic acid [HCV RNA] less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.
    Time Frame4 weeks after the last actual dose of study drug

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treat population: all participants who received at least 1 dose of study drug
    Arm/Group TitleArm AArm BArm CArm DArm EArm FArm GArm HArm IArm JArm K
    Arm/Group DescriptionABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
    Measure Participants4039000270034034
    Number (95% Confidence Interval) [percentage of participants]
    100
    238.1%
    97.4
    249.7%
    96.3
    Infinity
    100
    Infinity
    100
    Infinity
    3. Secondary Outcome
    TitlePercentage of Participants With On-treatment Virologic Failure
    DescriptionThe percentage of participants with on-treatment virologic failure (defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment), confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
    Time FrameScreening, Day 1, Day 3, treatment weeks 1, 2, 4, 6, 8, 10, and 12 or premature discontinuation from treatment

    Outcome Measure Data

    Analysis Population Description
    Intention-to-treat population: all participants who received at least 1 dose of study drug
    Arm/Group TitleArm AArm BArm CArm DArm EArm FArm GArm HArm IArm JArm K
    Arm/Group DescriptionABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
    Measure Participants4039000270034034
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    0
    0%
    0
    NaN
    0
    NaN
    0
    NaN
    4. Secondary Outcome
    TitlePercentage of Participants With Post-treatment Relapse
    DescriptionPost-treatment relapse was defined as confirmed hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantitation (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
    Time FrameFrom the end of treatment through 12 weeks after the last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit
    Arm/Group TitleArm AArm BArm CArm DArm EArm FArm GArm HArm IArm JArm K
    Arm/Group DescriptionABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened - Sponsor decision)ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
    Measure Participants4038000270034033
    Number (95% Confidence Interval) [percentage of participants]
    0
    0%
    2.6
    6.7%
    3.7
    Infinity
    0
    NaN
    0
    NaN

    Adverse Events

    Time FrameTreatment-emergent adverse events (TEAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug, up to 16 weeks. Serious adverse events were collected starting after the study-specific informed consent was signed and continuing until 30 days after the last dose of study drug, up to 23 weeks.
    Adverse Event Reporting Description
    Arm/Group TitleArm AArm BArm FArm IArm K
    Arm/Group DescriptionABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosisABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosisABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6- infected participants without cirrhosisABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis
    All Cause Mortality
    Arm AArm BArm FArm IArm K
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Arm AArm BArm FArm IArm K
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total1/42 (2.4%) 0/39 (0%) 1/27 (3.7%) 0/32 (0%) 1/34 (2.9%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ADENOCARCINOMA0/42 (0%) 0/39 (0%) 0/27 (0%) 0/32 (0%) 1/34 (2.9%)
    PROSTATE CANCER METASTATIC1/42 (2.4%) 0/39 (0%) 0/27 (0%) 0/32 (0%) 0/34 (0%)
    Respiratory, thoracic and mediastinal disorders
    PULMONARY EMBOLISM0/42 (0%) 0/39 (0%) 1/27 (3.7%) 0/32 (0%) 0/34 (0%)
    Other (Not Including Serious) Adverse Events
    Arm AArm BArm FArm IArm K
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total22/42 (52.4%) 22/39 (56.4%) 9/27 (33.3%) 20/32 (62.5%) 19/34 (55.9%)
    Eye disorders
    VISION BLURRED0/42 (0%) 1/39 (2.6%) 0/27 (0%) 2/32 (6.3%) 0/34 (0%)
    Gastrointestinal disorders
    CONSTIPATION0/42 (0%) 0/39 (0%) 0/27 (0%) 1/32 (3.1%) 2/34 (5.9%)
    DIARRHOEA3/42 (7.1%) 3/39 (7.7%) 1/27 (3.7%) 5/32 (15.6%) 3/34 (8.8%)
    DRY MOUTH0/42 (0%) 0/39 (0%) 0/27 (0%) 2/32 (6.3%) 0/34 (0%)
    FLATULENCE3/42 (7.1%) 0/39 (0%) 0/27 (0%) 2/32 (6.3%) 0/34 (0%)
    NAUSEA5/42 (11.9%) 8/39 (20.5%) 0/27 (0%) 3/32 (9.4%) 3/34 (8.8%)
    General disorders
    FATIGUE10/42 (23.8%) 5/39 (12.8%) 3/27 (11.1%) 3/32 (9.4%) 6/34 (17.6%)
    PAIN1/42 (2.4%) 1/39 (2.6%) 0/27 (0%) 1/32 (3.1%) 2/34 (5.9%)
    PYREXIA3/42 (7.1%) 1/39 (2.6%) 0/27 (0%) 0/32 (0%) 0/34 (0%)
    Infections and infestations
    UPPER RESPIRATORY TRACT INFECTION2/42 (4.8%) 1/39 (2.6%) 2/27 (7.4%) 1/32 (3.1%) 1/34 (2.9%)
    URINARY TRACT INFECTION1/42 (2.4%) 1/39 (2.6%) 0/27 (0%) 0/32 (0%) 3/34 (8.8%)
    Injury, poisoning and procedural complications
    MUSCLE STRAIN0/42 (0%) 0/39 (0%) 2/27 (7.4%) 1/32 (3.1%) 2/34 (5.9%)
    Metabolism and nutrition disorders
    DECREASED APPETITE0/42 (0%) 0/39 (0%) 1/27 (3.7%) 1/32 (3.1%) 2/34 (5.9%)
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA0/42 (0%) 1/39 (2.6%) 0/27 (0%) 3/32 (9.4%) 1/34 (2.9%)
    BACK PAIN1/42 (2.4%) 1/39 (2.6%) 1/27 (3.7%) 0/32 (0%) 2/34 (5.9%)
    Nervous system disorders
    DIZZINESS2/42 (4.8%) 2/39 (5.1%) 0/27 (0%) 2/32 (6.3%) 1/34 (2.9%)
    HEADACHE5/42 (11.9%) 8/39 (20.5%) 3/27 (11.1%) 8/32 (25%) 1/34 (2.9%)
    MEMORY IMPAIRMENT0/42 (0%) 2/39 (5.1%) 0/27 (0%) 0/32 (0%) 0/34 (0%)
    PARAESTHESIA1/42 (2.4%) 2/39 (5.1%) 0/27 (0%) 0/32 (0%) 0/34 (0%)
    Psychiatric disorders
    ANXIETY2/42 (4.8%) 3/39 (7.7%) 0/27 (0%) 0/32 (0%) 1/34 (2.9%)
    DEPRESSION2/42 (4.8%) 0/39 (0%) 1/27 (3.7%) 2/32 (6.3%) 0/34 (0%)
    INSOMNIA1/42 (2.4%) 3/39 (7.7%) 0/27 (0%) 1/32 (3.1%) 2/34 (5.9%)
    Respiratory, thoracic and mediastinal disorders
    COUGH2/42 (4.8%) 0/39 (0%) 0/27 (0%) 1/32 (3.1%) 3/34 (8.8%)
    PARANASAL SINUS DISCOMFORT0/42 (0%) 0/39 (0%) 0/27 (0%) 0/32 (0%) 2/34 (5.9%)
    Skin and subcutaneous tissue disorders
    HYPERHIDROSIS1/42 (2.4%) 0/39 (0%) 0/27 (0%) 0/32 (0%) 2/34 (5.9%)
    PRURITUS0/42 (0%) 1/39 (2.6%) 2/27 (7.4%) 1/32 (3.1%) 1/34 (2.9%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

    Results Point of Contact

    Name/TitleGlobal Medical Services
    OrganizationAbbVie
    Phone800-633-9110
    Email
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02243280
    Other Study ID Numbers:
    • M14-867
    • 2014-002925-36
    First Posted:
    Sep 17, 2014
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Jul 1, 2021