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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy

Primary Purpose

Chronic Hepatitis C, Hepatitis C Virus, HCV

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ABT-493, ABT-530
ribavirin (RBV)
ABT-493/ABT-530
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Hepatitis C, HCV Genotype 6, HCV GT1, Interferon (IFN) free, HCV Genotype 5, HCV, HCV GT4, HCV Genotype 4, Chronic Hepatitis C, Chronic HCV, Hepatitis C Genotype 1, HCV GT5, HCV Genotype 1

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients from 18 to 70 years in Arms A, B, and C; patients 18 years of age or older in Arms D and E.
  2. Previous treatment with DAA-containing regimen for chronic hepatitis C virus (HCV) infection resulting in either on-treatment virologic failure or post-treatment relapse
  3. Chronic HCV genotype (GT) 1, 4, 5, or 6-infection (GT4-6 in Arms D and E)

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
  4. Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
  5. Co-infection with more than one HCV genotype

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Arm A

    Arm B

    Arm C

    Arm D

    Arm E

    Arm Description

    ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.

    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.

    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
    SVR12 was defined as 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

    Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)
    SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.
    Percentage of Participants With On-treatment Virologic Failure
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU 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.
    Percentage of Participants With Post-treatment Relapse
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.

    Full Information

    First Posted
    May 14, 2015
    Last Updated
    August 17, 2017
    Sponsor
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02446717
    Brief Title
    A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy
    Official Title
    A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    AbbVie

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the efficacy and safety of ABT-493 and ABT-530 with or without ribavirin (RBV) in participants with chronic hepatitis C virus, (HCV)-infection who previously failed treatment with a direct acting antiviral (DAA)-containing regimen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C, Hepatitis C Virus, HCV, Direct-Acting Antiviral Agent (DAA)-Experienced
    Keywords
    Hepatitis C, HCV Genotype 6, HCV GT1, Interferon (IFN) free, HCV Genotype 5, HCV, HCV GT4, HCV Genotype 4, Chronic Hepatitis C, Chronic HCV, Hepatitis C Genotype 1, HCV GT5, HCV Genotype 1

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    141 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A
    Arm Type
    Experimental
    Arm Description
    ABT-493 (200 mg) once daily (QD) co-administered with ABT-530 (80 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
    Arm Title
    Arm B
    Arm Type
    Experimental
    Arm Description
    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus ribavirin (RBV) for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
    Arm Title
    Arm C
    Arm Type
    Experimental
    Arm Description
    ABT-493 (300 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD for 12 weeks in chronic HCV genotype 1- infected participants without cirrhosis.
    Arm Title
    Arm D
    Arm Type
    Experimental
    Arm Description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks in HCV genotypes 1- or 4-6- infected participants with or without cirrhosis.
    Arm Title
    Arm E
    Arm Type
    Experimental
    Arm Description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 16 weeks in HCV genotype 1- or 4-6- infected participants with or without cirrhosis.
    Intervention Type
    Drug
    Intervention Name(s)
    ABT-493, ABT-530
    Other Intervention Name(s)
    ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, ABT-493/ABT-530 (ABT-493 coformulated with ABT-267) also known as MAVYRET
    Intervention Description
    ABT-493 (tablet) dosed with ABT-530 (tablet)
    Intervention Type
    Drug
    Intervention Name(s)
    ribavirin (RBV)
    Intervention Description
    Tablet
    Intervention Type
    Drug
    Intervention Name(s)
    ABT-493/ABT-530
    Other Intervention Name(s)
    ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVYRET
    Intervention Description
    Tablet; ABT-493 coformulated with ABT-530
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
    Description
    SVR12 was defined as 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 Frame
    12 weeks after the last actual dose of study drug
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Sustained Virologic Response 4 Weeks Post-treatment (SVR4)
    Description
    SVR4 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 4 weeks after the last dose of study drug.
    Time Frame
    4 weeks after the last actual dose of study drug
    Title
    Percentage of Participants With On-treatment Virologic Failure
    Description
    On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU 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 Frame
    Day 3, Treatment Weeks 1, 2, 4, 6, 8, 10, 12 (end of treatment for 12-week treatment arms), and 16 (end of treatment for 16-week treatment arm) or premature discontinuation from treatment
    Title
    Percentage of Participants With Post-treatment Relapse
    Description
    Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.
    Time Frame
    From the end of treatment through 12 weeks after the last dose of study drug

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients from 18 to 70 years in Arms A, B, and C; patients 18 years of age or older in Arms D and E. Previous treatment with DAA-containing regimen for chronic hepatitis C virus (HCV) infection resulting in either on-treatment virologic failure or post-treatment relapse Chronic HCV genotype (GT) 1, 4, 5, or 6-infection (GT4-6 in Arms D and E) Exclusion Criteria: History of severe, life-threatening or other significant sensitivity to any drug 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 Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol Positive for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) Co-infection with more than one HCV genotype
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    AbbVie Inc
    Organizational Affiliation
    AbbVie
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28128852
    Citation
    Poordad F, Felizarta F, Asatryan A, Sulkowski MS, Reindollar RW, Landis CS, Gordon SC, Flamm SL, Fried MW, Bernstein DE, Lin CW, Liu R, Lovell SS, Ng TI, Kort J, Mensa FJ. Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology. 2017 Aug;66(2):389-397. doi: 10.1002/hep.29081. Epub 2017 Apr 10. Erratum In: Hepatology. 2017 Nov;66(5):1708.
    Results Reference
    result
    PubMed Identifier
    31568620
    Citation
    Brown A, Welzel TM, Conway B, Negro F, Brau N, Grebely J, Puoti M, Aghemo A, Kleine H, Pugatch D, Mensa FJ, Chen YJ, Lei Y, Lawitz E, Asselah T. Adherence to pan-genotypic glecaprevir/pibrentasvir and efficacy in HCV-infected patients: A pooled analysis of clinical trials. Liver Int. 2020 Apr;40(4):778-786. doi: 10.1111/liv.14266. Epub 2019 Oct 18.
    Results Reference
    derived
    PubMed Identifier
    30977945
    Citation
    Back D, Belperio P, Bondin M, Negro F, Talal AH, Park C, Zhang Z, Pinsky B, Crown E, Mensa FJ, Marra F. Efficacy and safety of glecaprevir/pibrentasvir in patients with chronic HCV infection and psychiatric disorders: An integrated analysis. J Viral Hepat. 2019 Aug;26(8):951-960. doi: 10.1111/jvh.13110. Epub 2019 May 20.
    Results Reference
    derived
    PubMed Identifier
    30923816
    Citation
    Gane E, Poordad F, Zadeikis N, Valdes J, Lin CW, Liu W, Asatryan A, Wang S, Stedman C, Greenbloom S, Nguyen T, Elkhashab M, Worns MA, Tran A, Mulkay JP, Setze C, Yu Y, Pilot-Matias T, Porcalla A, Mensa FJ. Safety and Pharmacokinetics of Glecaprevir/Pibrentasvir in Adults With Chronic Genotype 1-6 Hepatitis C Virus Infections and Compensated Liver Disease. Clin Infect Dis. 2019 Oct 30;69(10):1657-1664. doi: 10.1093/cid/ciz022.
    Results Reference
    derived
    PubMed Identifier
    30012435
    Citation
    Flamm S, Reddy KR, Zadeikis N, Hassanein T, Bacon BR, Maieron A, Zeuzem S, Bourliere M, Calleja JL, Kosloski MP, Oberoi RK, Lin CW, Yu Y, Lovell S, Semizarov D, Mensa FJ. Efficacy and Pharmacokinetics of Glecaprevir and Pibrentasvir With Concurrent Use of Acid-Reducing Agents in Patients With Chronic HCV Infection. Clin Gastroenterol Hepatol. 2019 Feb;17(3):527-535.e6. doi: 10.1016/j.cgh.2018.07.003. Epub 2018 Sep 10.
    Results Reference
    derived
    Links:
    URL
    http://rxabbvie.com
    Description
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    A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy

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