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A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) (Navigator)

Primary Purpose

Hepatitis C Virus

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ABT-450
ABT-267
ribavirin
ritonavir
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus focused on measuring Genotype 1, Genotype 2, Genotype 3, Hepatitis C Virus, ABT-450/r, Ribavirin, ABT-267, Ombitasvir, Paritaprevir

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants who had a body mass index 18 to < 35 kg/m^2.
  • Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control.
  • Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study.
  • Participants were in a condition of general good health, other than the HCV infection.
  • Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA > 50,000 IU/mL, and FibroTest score <= 0.72 and aspartate aminotransferase (AST) to platelet ratio index <= 2, Fibroscan® result of < 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.

Exclusion Criteria:

  • Positive drug screen
  • Previous use of anti-HCV agents
  • History of cardiac disease
  • History of uncontrolled diabetes or diabetes requiring insulin
  • Abnormal laboratory results
  • Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV
  • Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    ABT-450/r and ABT-267 plus RBV in genotype 1 participants

    ABT-450/r and ABT-267 plus RBV in genotype 2 participants

    ABT-450/r and ABT-267 plus RBV in genotype 3 participants

    ABT-450/r and ABT-267 in genotype 1 participants

    ABT-450/r and ABT-267 in genotype 2 participants

    ABT-450/r and ABT-267 in genotype 3 participants

    Arm Description

    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.

    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.

    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.

    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.

    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.

    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]
    Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.

    Secondary Outcome Measures

    Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
    Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
    Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
    Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
    Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
    Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.
    Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)
    Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.
    Percentage of Participants With Virologic Failure During Treatment
    Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment).
    Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)
    Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures.

    Full Information

    First Posted
    September 23, 2011
    Last Updated
    May 31, 2016
    Sponsor
    AbbVie (prior sponsor, Abbott)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01458535
    Brief Title
    A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)
    Acronym
    Navigator
    Official Title
    An Open-Label, Sequential Arm, Multicenter Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-267 With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV) Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    May 2013 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie (prior sponsor, Abbott)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.
    Detailed Description
    This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts: one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and a post-treatment phase. The treatment phase was designed to explore the antiviral activity, safety and pharmacokinetics of ABT-450/r dosed in combination with ABT-267 with and without RBV for up to 12 weeks. The post-treatment phase was designed to monitor and evaluate Sustained Virologic Response (SVR) 12, SVR 24, and the evolution and persistence of viral resistance to ABT-267 and ABT-450 in HCV genotype 1-, 2-, and 3-infected participants who have been exposed to ABT-267 and ABT-450/r. Arms 1 and 2 were enrolled sequentially.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C Virus
    Keywords
    Genotype 1, Genotype 2, Genotype 3, Hepatitis C Virus, ABT-450/r, Ribavirin, ABT-267, Ombitasvir, Paritaprevir

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ABT-450/r and ABT-267 plus RBV in genotype 1 participants
    Arm Type
    Experimental
    Arm Description
    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
    Arm Title
    ABT-450/r and ABT-267 plus RBV in genotype 2 participants
    Arm Type
    Experimental
    Arm Description
    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
    Arm Title
    ABT-450/r and ABT-267 plus RBV in genotype 3 participants
    Arm Type
    Experimental
    Arm Description
    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
    Arm Title
    ABT-450/r and ABT-267 in genotype 1 participants
    Arm Type
    Experimental
    Arm Description
    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
    Arm Title
    ABT-450/r and ABT-267 in genotype 2 participants
    Arm Type
    Experimental
    Arm Description
    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
    Arm Title
    ABT-450/r and ABT-267 in genotype 3 participants
    Arm Type
    Experimental
    Arm Description
    ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
    Intervention Type
    Drug
    Intervention Name(s)
    ABT-450
    Other Intervention Name(s)
    paritaprevir
    Intervention Description
    tablets
    Intervention Type
    Drug
    Intervention Name(s)
    ABT-267
    Other Intervention Name(s)
    ombitasvir
    Intervention Description
    tablets
    Intervention Type
    Drug
    Intervention Name(s)
    ribavirin
    Intervention Description
    tablets
    Intervention Type
    Drug
    Intervention Name(s)
    ritonavir
    Other Intervention Name(s)
    Norvir
    Intervention Description
    capsules
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12 [(Extended Rapid Virologic Response (eRVR)]
    Description
    Analysis of the percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.
    Time Frame
    Week 4 through Week 12
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
    Description
    Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
    Time Frame
    Post-treatment Day 1 to Post-treatment Week 12
    Title
    Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
    Description
    Sustained Virologic Response 24 (SVR24) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ; < 25 IU/mL) 24 weeks after the last dose of study drug. Participants with missing data were imputed as failures.
    Time Frame
    Post-treatment Day 1 to Post-treatment Week 24
    Title
    Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
    Description
    Analysis of participants with HCV RNA levels below 1000 IU/mL at Week 2. Participants with missing data were imputed as failures.
    Time Frame
    Week 2
    Title
    Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4 Rapid Virologic Response (RVR)
    Description
    Analysis of percentage of participants with hepatitis C virus ribonucleic acid less than the lower limit of quantitation (< 25 IU/mL). Participants with missing data were imputed as failures.
    Time Frame
    Week 4
    Title
    Percentage of Participants With Virologic Failure During Treatment
    Description
    Virologic failure during treatment is defined as a participant meeting any virologic stopping criteria, including 1) rebound (defined as the first day of 2 consecutive increases of at least 0.5 log10 IU/mL above nadir (local minimum value), or first day of 2 consecutive HCV RNA >= LLOQ for participants who previously achieved HCV RNA < LLOQ) during treatment, 2) participant who fails to suppress (defined as never achieving HCV RNA < LLOQ during treatment).
    Time Frame
    Day 1 through Week 12
    Title
    Percentage of Participants Who Experienced Virologic Relapse Through End of Post Treatment Period (up to 48 Weeks)
    Description
    Virologic relapse is defined as confirmed hepatitis C virus (HCV) ribonucleic acid (RNA) >= lower limit of quantitation (LLOQ) (2 consecutive measurements >= LLOQ) at any point in the post-treatment period among participants with HCV RNA < LLOQ at the end of treatment. Participants with missing data were imputed as failures.
    Time Frame
    Post-treatment Day 1 to Post-treatment Week 48

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participants who had a body mass index 18 to < 35 kg/m^2. Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control. Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study. Participants were in a condition of general good health, other than the HCV infection. Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA > 50,000 IU/mL, and FibroTest score <= 0.72 and aspartate aminotransferase (AST) to platelet ratio index <= 2, Fibroscan® result of < 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy. Exclusion Criteria: Positive drug screen Previous use of anti-HCV agents History of cardiac disease History of uncontrolled diabetes or diabetes requiring insulin Abnormal laboratory results Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrew Campbell, MD
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.rxabbvie.com/
    Description
    Related Info

    Learn more about this trial

    A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

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