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A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-4)

Primary Purpose

Chronic Hepatitis C Virus (HCV) Infection

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
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 Virus (HCV) Infection focused on measuring Treatment-naïve, HCV Gentoype 2, Non-cirrhotic, Chronic Hepatitis C, HCV Gentoype 5, HCV Gentoype 4, HCV Gentoype 6, HCV Gentoype 1, Compensated cirrhotic, Treatment-experienced, HCV Gentoype 3

Eligibility Criteria

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

Inclusion Criteria:

  • Chronic hepatitis C virus (HCV) infection
  • Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection.
  • Subject must be HCV treatment-naïve or have failed previous HCV treatment.
  • Subjects with underlying chronic renal impairment (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as estimated by the MDRD method at screening, including those requiring dialysis).
  • Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with cirrhosis must have documented compensated cirrhosis.

Exclusion Criteria:

  • History of severe, life-threatening or other significant sensitivity to any excipients of the study 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 in the opinion of the investigator.
  • Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
  • HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype; HCV GT3 infected, treatment-experienced subjects were excluded.
  • Patients who failed a previous regimen containing protease inhibitor (PIs) and/or nonstructural protein 5A (NS5A) inhibitors.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ABT-493/ABT-530

    Arm Description

    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

    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 On-treatment Virologic Failure
    On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ 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 who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.

    Full Information

    First Posted
    January 7, 2016
    Last Updated
    September 14, 2017
    Sponsor
    AbbVie
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02651194
    Brief Title
    A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection
    Acronym
    EXPEDITION-4
    Official Title
    A Single-Arm, Open-Label, Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally-Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection (EXPEDITION-4)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (Actual)
    Primary Completion Date
    October 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 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection and chronic severe renal impairment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C Virus (HCV) Infection
    Keywords
    Treatment-naïve, HCV Gentoype 2, Non-cirrhotic, Chronic Hepatitis C, HCV Gentoype 5, HCV Gentoype 4, HCV Gentoype 6, HCV Gentoype 1, Compensated cirrhotic, Treatment-experienced, HCV Gentoype 3

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ABT-493/ABT-530
    Arm Type
    Experimental
    Arm Description
    ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.
    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 On-treatment Virologic Failure
    Description
    On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
    Time Frame
    up to 12 weeks
    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 who completed treatment 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: Chronic hepatitis C virus (HCV) infection Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection. Subject must be HCV treatment-naïve or have failed previous HCV treatment. Subjects with underlying chronic renal impairment (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as estimated by the MDRD method at screening, including those requiring dialysis). Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with cirrhosis must have documented compensated cirrhosis. Exclusion Criteria: History of severe, life-threatening or other significant sensitivity to any excipients of the study 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 in the opinion of the investigator. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab). HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype; HCV GT3 infected, treatment-experienced subjects were excluded. Patients who failed a previous regimen containing protease inhibitor (PIs) and/or nonstructural protein 5A (NS5A) inhibitors.
    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
    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
    30529905
    Citation
    Foster GR, Dore GJ, Wang S, Grebely J, Sherman KE, Baumgarten A, Conway B, Jackson D, Asselah T, Gschwantler M, Tomasiewicz K, Aguilar H, Asatryan A, Hu Y, Mensa FJ. Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies. Drug Alcohol Depend. 2019 Jan 1;194:487-494. doi: 10.1016/j.drugalcdep.2018.11.007. Epub 2018 Nov 24.
    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
    PubMed Identifier
    29020583
    Citation
    Gane E, Lawitz E, Pugatch D, Papatheodoridis G, Brau N, Brown A, Pol S, Leroy V, Persico M, Moreno C, Colombo M, Yoshida EM, Nelson DR, Collins C, Lei Y, Kosloski M, Mensa FJ. Glecaprevir and Pibrentasvir in Patients with HCV and Severe Renal Impairment. N Engl J Med. 2017 Oct 12;377(15):1448-1455. doi: 10.1056/NEJMoa1704053.
    Results Reference
    derived
    Links:
    URL
    http://rxabbvie.com
    Description
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    A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection

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