Quality of Life Measurement in Treatment Naïve Patients With Hepatitis C Virus (HCV) Genotype 1 (GT1) Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir and Dasabuvir (Viekirax®/Exviera®)

Study Identifier
P16-272
CT.gov Identifier
NCT03002818
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Scientific Result Summary
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Treatment-naïve participants * Mono-infected participants with chronic HCV GT1 * Non-cirrhotic participants * Participants with debilitating fatigue (Fatigue Severity Scale \[FSS\] greater than or equal to 4)
    Exclusion Criteria:
    * Participants with sources of fatigue other than HCV (especially, severe depression, cancer and hormonal disorders causing clinically significant fatigue) * Participants with conditions that do not allow to adhere to protocol and use of the device at investigator's discretion * Participants who are wheelchair dependent

    Protocol Summary

    This is an observational, prospective, open-label, single-arm, multicenter, real-life study designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in participants with HCV GT1.

    Study Locations

    Location
    Status
    Location
    Kantonsspital St. Gallen
    Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
    Status
    Not applicable
    Location
    Inselspital, Universitaetsklin
    Bern, Switzerland, 3010
    Status
    Not applicable
    Location
    Fondazione Epatocentro Ticino
    Lugano, Switzerland, 6900
    Status
    Not applicable
    Location
    Hopital Neuchatelois
    Neuchâtel, Switzerland, CH-2000
    Status
    Not applicable
    Location
    Universitaetsspital Zuerich
    Zurich, Switzerland, 8091
    Status
    Not applicable