Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT03341871
Collaborator
(none)
1,095
1
32.6
33.6

Study Details

Study Description

Brief Summary

This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1095 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
    Actual Study Start Date :
    Dec 27, 2017
    Actual Primary Completion Date :
    Sep 15, 2020
    Actual Study Completion Date :
    Sep 15, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    HCV Genotypes 1, 2, 3, 4, 5, or 6 participants

    Participants receiving combination therapy with the glecaprevir plus pibrentasvir (GLE/PIB) regimen according to the current local label.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) [12 weeks after last dose of drug]

      SVR12 defined as the hepatitis C virus (HCV) ribonucleic acid (RNA) level < the lower limit of quantification (LLOQ) 12 weeks after the last dose of Glecaprevir plus Pibrentasvir.

    Secondary Outcome Measures

    1. Percentage of Participants with Post-treatment Relapse [Up to 24 weeks after last dose of drug]

      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.

    2. Percentage of Participants with On-treatment Virologic Failure [Up to 12 weeks after first dose]

      On-treatment virologic failure was defined as HCV RNA levels reach < LLOQ during treatment then increase to >= LLOQ during treatment, or confirmed increase of > 1 log10 IU/mL above the lowest value post-baseline HCV RNA during treatment.

    3. Percentage of Participants Achieving SVR4 [4 weeks after last dose]

      SVR4 defined as defined as the HCV RNA level < LLOQ 4 weeks after the last dose of Glecaprevir plus Pibrentasvir.

    4. Percentage of Participants Achieving SVR8 [8 weeks after last dose of drug]

      SVR8 defined as defined as the HCV RNA level < LLOQ 8 weeks after the last dose of Glecaprevir plus Pibrentasvir.

    5. Percentage of Participants Achieving SVR24 [24 weeks after last dose of drug]

      SVR24 defined as the HCV RNA level < LLOQ 24 weeks after the last dose of Glecaprevir plus Pibrentasvir.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with chronic hepatitis C virus infection and administering glecaprevir plus pibrentasvir.
    Exclusion Criteria:
    • Patients previously treated with glecaprevir plus pibrentasvir.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Abbvie Japan /ID# 161985 Tokyo Japan 108-6302

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT03341871
    Other Study ID Numbers:
    • P16-570
    First Posted:
    Nov 14, 2017
    Last Update Posted:
    Sep 20, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 20, 2021