Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C

Study Identifier
P15-788
CT.gov Identifier
NCT02817594
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
Available Language(s): English
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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
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label. * If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy). * Participants must voluntarily sign and date informed consent prior to inclusion into the study
    Exclusion Criteria:
    * Patients participating or intending to participate in a concurrent interventional therapeutic trial. * Unable to complete the questionnaires due to cognitive impairment or lack of any kind of cognitive competence, as to be judged by the healthcare professional who is treating the patient. * Unable to complete the questionnaires due to language incompetence. * Unable to voluntarily sign and date the informed consent.

    Protocol Summary

    The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.

    This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in the Netherlands in a clinical practice patient population.

    Study Locations

    Location
    Status
    Location
    Albert Schweitzer Ziekenhuis /ID# 152597
    Dordrecht, South Holland, Netherlands, 3318 AT
    Status
    Not applicable
    Location
    Noordwest Ziekenhuisgroep /ID# 152604
    Alkmaar, Netherlands, 1815 JD
    Status
    Not applicable
    Location
    Duplicate_Onze Lieve Vrouwe Gasthuis /ID# 152600
    Amsterdam, Netherlands, 1061 AE
    Status
    Not applicable
    Location
    Universitair Medisch Centrum Groningen /ID# 152596
    Groningen, Netherlands, 9713 GZ
    Status
    Not applicable
    Location
    Leids Universitair Medisch Centrum /ID# 154637
    Leiden, Netherlands, 2333 ZA
    Status
    Not applicable
    Location
    Radbound University Medical Ce /ID# 152598
    Nijmegen, Netherlands, 6526 GA
    Status
    Not applicable
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