Study of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C Genotypes 1 to 6

Study Identifier
P17-094
CT.gov Identifier
NCT03303599
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Participants are treatment-naïve or treatment-experienced with pegylatedinterferon (pegIFN), or IFN, and/or ribavirin (RBV) and/or sofosbuvir (PRS) with confirmed chronic hepatitis C (CHC), genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral glecaprevir plus pibrentasvir (GLE/PIB) regimen according to standard of care, international guidelines and in line with the current local label. * Participants may be enrolled up to 4 weeks after treatment initiation * Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial.
    Exclusion Criteria:
    None.

    Protocol Summary

    The interferon- and ribavirin- (RBV) free combination regimen of glecaprevir plus pibrentasvir (GLE/PIB) for the treatment of genotypes 1 to 6 of chronic hepatitis C (CHC) viral infection has been shown to be safe and effective in randomized controlled clinical trials.

    This observational study is an effectiveness research examining the regimen of GLE/PIB, used according to local label, under real world conditions in a clinical practice patient population.

    Study Locations

    Location
    Status
    Location
    Klinikum Klagenfurt am Woerthersee, Apotheke /ID# 169931
    Klagenfurt, Carinthia, Austria, 9020
    Status
    Not applicable
    Location
    University Hospital St. Polten /ID# 169918
    Sankt Pölten, Lower Austria, Austria, 3100
    Status
    Not applicable
    Location
    Medizinische Universität Graz /ID# 169932
    Graz, Styria, Austria, 8020
    Status
    Not applicable
    Location
    Landeskrankenhaus Hall /ID# 169930
    Hall in Tirol, Tyrol, Austria, 6060
    Status
    Not applicable
    Location
    KH der Elisabethinen Linz GmbH /ID# 169915
    Linz, Upper Austria, Austria, 4010
    Status
    Not applicable
    Location
    Landeskrankenhaus /ID# 169922
    Innsbruck, Austria, 6020
    Status
    Not applicable
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