PEARL-III: A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection

Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01767116
Collaborator
(none)
419
Enrollment
2
Arms
20
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

Condition or DiseaseIntervention/TreatmentPhase
Phase 3

Detailed Description

A randomized, double-blind, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-naïve, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection.

Study Design

Study Type:
Interventional
Actual Enrollment :
419 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naive Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-III)
Study Start Date :
Dec 1, 2012
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

ArmIntervention/Treatment
Experimental: ABT-450/r/ABT-267 and ABT-333, Plus RBV

ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Drug: ABT-450/r/ABT-267, ABT-333
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK
  • Drug: Ribavirin
    Capsule

    Experimental: ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV

    ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks

    Drug: ABT-450/r/ABT-267, ABT-333
    Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
    Other Names:
  • ABT-267 also known as ombitasvir
  • ABT-450 also known as paritaprevir
  • ABT-333 also known as dasabuvir
  • Viekira PAK
  • Drug: Placebo for ribavirin
    Capsule

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate [12 weeks after last 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 quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN).

    Secondary Outcome Measures

    1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV [12 weeks after last 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 quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.

    2. Percentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment [Baseline (Day 1) and Week 12 (End of Treatment)]

      The percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.

    3. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate [12 weeks after last dose of study drug]

      The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV.

    4. Percentage of Participants With Virologic Failure During Treatment [Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12]

      Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).

    5. Percentage of Participants With Virologic Relapse After Treatment [Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)]

      Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile

    • Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)

    • Subject has never received antiviral treatment for hepatitis C infection

    • No evidence of liver cirrhosis

    Exclusion Criteria:
    • Significant liver disease with any cause other than HCV as the primary cause

    • Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

    • Positive screen for drugs or alcohol

    • Significant sensitivity to any drug

    • Use of contraindicated medications within 2 weeks of dosing

    • Abnormal laboratory tests

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • AbbVie (prior sponsor, Abbott)

    Investigators

    • Study Director: Dan Cohen, MD, AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01767116
    Other Study ID Numbers:
    • M13-961
    • 2012-003687-52
    First Posted:
    Jan 14, 2013
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Arm/Group DescriptionABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeksABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
    Period Title: Overall Study
    STARTED210209
    COMPLETED208207
    NOT COMPLETED22

    Baseline Characteristics

    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBVTotal
    Arm/Group DescriptionABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeksABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeksTotal of all reporting groups
    Overall Participants210209419
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    48.4
    (11.94)
    49.2
    (12.03)
    48.8
    (11.98)
    Sex: Female, Male (Count of Participants)
    Female
    104
    49.5%
    123
    58.9%
    227
    54.2%
    Male
    106
    50.5%
    86
    41.1%
    192
    45.8%

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate
    DescriptionThe percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN).
    Time Frame12 weeks after last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug (intent-to-treat [ITT] population); participants with missing data were counted as non-responders.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Arm/Group DescriptionABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeksABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
    Measure Participants210209
    Number [percentage of participants]
    99.5
    47.4%
    100.0
    47.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Comments For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides >95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).
    Type of Statistical Test Non-Inferiority or Equivalence (legacy)
    Comments The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% confidence interval (95% CI) for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterPercentage of Participants
    Estimated Value100
    Confidence Interval (2-Sided) 95%
    98.2 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments95% CI was calculated using the Wilson score method for the single proportion because the point estimate was 100%..
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Comments For the primary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides >95% power to demonstrate noninferiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).
    Type of Statistical Test Non-Inferiority or Equivalence (legacy)
    Comments The noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group as compared with the historical rate for telaprevir plus pegIFN-RBV was analyzed; the lower confidence bound of the 2-sided 95% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 73% to achieve noninferiority.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterPercentage of Participants
    Estimated Value99.5
    Confidence Interval (2-Sided) 95%
    98.6 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments95% CI was calculated using the normal approximation to the binomial distribution.
    2. Secondary Outcome
    TitlePercentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV
    DescriptionThe percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV.
    Time Frame12 weeks after last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Arm/Group DescriptionABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeksABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
    Measure Participants210209
    Number [percentage of participants]
    99.5
    47.4%
    100
    47.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV, ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Comments For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a -10% margin, a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per arm provides >95% power to demonstrate noninferiority of ABT-450/r/ABT-267 and ABT-333, plus Placebo RBV compared with ABT-450/r/ABT-267 and ABT-333, plus RBV (normal approximation of a single binomial proportion in a 1-sample test for superiority).
    Type of Statistical Test Non-Inferiority or Equivalence (legacy)
    Comments Noninferiority of the rate of sustained virologic response at 12 weeks after treatment for the ABT-450/r/ABT-267 and ABT-333, plus placebo RBV treatment group as compared with the ABT-450/r/ABT-267 and ABT-333, plus RBV treatment group was analyzed using a noninferiority margin of -10.5%. The lower confidence bound of the 2-sided 95% CI for the difference in percentage of participants with sustained virologic response at 12 weeks after treatment must exceed -10.5% to achieve noninferiority.
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterDifference in Percentage of Participants
    Estimated Value0.5
    Confidence Interval (2-Sided) 95%
    -0.5 to 1.4
    Parameter Dispersion Type:
    Value:
    Estimation Comments95% CI was calculated using the normal approximation to the binomial distribution.
    3. Secondary Outcome
    TitlePercentage of Participants With Hemoglobin Decrease to Below the Lower Limit of Normal (LLN) At End of Treatment
    DescriptionThe percentage of participants with a decrease in hemoglobin from greater than or equal to the lower limit of normal (≥ LLN) at baseline to < LLN at the end of treatment.
    Time FrameBaseline (Day 1) and Week 12 (End of Treatment)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug (ITT population) and had hemoglobin ≥ LLN reference range at baseline.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Arm/Group DescriptionABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeksABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
    Measure Participants207205
    Number [percentage of participants]
    51.2
    24.4%
    3.4
    1.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV, ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value<0.001
    Comments
    MethodFisher Exact
    Comments
    4. Secondary Outcome
    TitlePercentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate
    DescriptionThe percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV.
    Time Frame12 weeks after last dose of study drug

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug (ITT population); participants with missing data were counted as non-responders.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Arm/Group DescriptionABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeksABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
    Measure Participants210209
    Number [percentage of particpants]
    99.5
    100
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Comments For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides >90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterPercentage of Participants
    Estimated Value100
    Confidence Interval (2-Sided) 95%
    98.2 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments95% CI calculated using the Wilson score method for the single proportion; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection ABT-450/r/ABT-267 and ABT-333, Plus RBV
    Comments For the secondary efficacy endpoint of sustained virologic response at 12 weeks after treatment, based on a 2-sided significance level of 0.05 and an underlying rate of 92% or higher in each arm, a sample size of 200 participants per treatment arm provides >90% power to demonstrate superiority of each regimen to the historical rate for telaprevir plus pegIFN and RBV therapy (84%) (based on the normal approximation of a single binomial proportion in a one-sample test for superiority).
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesisp-Value
    Comments
    Method
    Comments
    Method of EstimationEstimation ParameterPercentage of Participants
    Estimated Value99.5
    Confidence Interval (2-Sided) 95%
    98.6 to 100.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments95% CI calculated using the normal approximation to the binomial distribution; the lower confidence bound for the percentage of participants with sustained virologic response at 12 weeks after treatment must exceed 84% to achieve superiority.
    5. Secondary Outcome
    TitlePercentage of Participants With Virologic Failure During Treatment
    DescriptionVirologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above the lowest value post baseline] at any time point during treatment), or failure to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
    Time FrameBaseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, and 12

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug (ITT population).
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Arm/Group DescriptionABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeksABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
    Measure Participants210209
    Rebound
    0.5
    0.2%
    0
    0%
    Failure to suppress
    0
    0%
    0
    0%
    6. Secondary Outcome
    TitlePercentage of Participants With Virologic Relapse After Treatment
    DescriptionParticipants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.
    Time FrameBetween End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who received at least 1 dose of study drug (ITT population) with HCV RNA < LLOQ at the final treatment visit and completed treatment.
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Arm/Group DescriptionABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeksABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
    Measure Participants208207
    Number [percentage of participants]
    0
    0%
    0
    0%

    Adverse Events

    Time FrameAEs were collected from the time of study drug administration to 30 days after last dose of study drug (16 weeks); SAEs were also collected from the time that informed consent was obtained until the end of participation in the study (up to 65 weeks)
    Adverse Event Reporting Description
    Arm/Group TitleABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Arm/Group DescriptionABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeksABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
    All Cause Mortality
    ABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    ABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total4/210 (1.9%) 4/209 (1.9%)
    Cardiac disorders
    ATRIAL FIBRILLATION1/210 (0.5%) 0/209 (0%)
    CORONARY ARTERY DISEASE1/210 (0.5%) 0/209 (0%)
    Musculoskeletal and connective tissue disorders
    ARTHRITIS0/210 (0%) 1/209 (0.5%)
    MYALGIA0/210 (0%) 1/209 (0.5%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    INTRADUCTAL PROLIFERATIVE BREAST LESION0/210 (0%) 1/209 (0.5%)
    Renal and urinary disorders
    NEPHROLITHIASIS1/210 (0.5%) 0/209 (0%)
    Reproductive system and breast disorders
    EPIDIDYMITIS1/210 (0.5%) 0/209 (0%)
    UTERINE POLYP0/210 (0%) 1/209 (0.5%)
    Other (Not Including Serious) Adverse Events
    ABT-450/r/ABT-267 and ABT-333, Plus RBVABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total133/210 (63.3%) 97/209 (46.4%)
    Blood and lymphatic system disorders
    ANAEMIA14/210 (6.7%) 1/209 (0.5%)
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER11/210 (5.2%) 6/209 (2.9%)
    DIARRHOEA9/210 (4.3%) 13/209 (6.2%)
    DYSPEPSIA14/210 (6.7%) 9/209 (4.3%)
    NAUSEA23/210 (11%) 9/209 (4.3%)
    General disorders
    ASTHENIA22/210 (10.5%) 12/209 (5.7%)
    FATIGUE45/210 (21.4%) 49/209 (23.4%)
    Nervous system disorders
    HEADACHE51/210 (24.3%) 49/209 (23.4%)
    Psychiatric disorders
    INSOMNIA19/210 (9%) 7/209 (3.3%)
    Respiratory, thoracic and mediastinal disorders
    COUGH19/210 (9%) 5/209 (2.4%)
    Skin and subcutaneous tissue disorders
    PRURITUS25/210 (11.9%) 11/209 (5.3%)
    RASH12/210 (5.7%) 8/209 (3.8%)

    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 Information
    OrganizationAbbVie (prior sponsor, Abbott)
    Phone800-633-9110
    Email
    Responsible Party:
    AbbVie (prior sponsor, Abbott)
    ClinicalTrials.gov Identifier:
    NCT01767116
    Other Study ID Numbers:
    • M13-961
    • 2012-003687-52
    First Posted:
    Jan 14, 2013
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021