Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C

Study Identifier
P15-842
CT.gov Identifier
NCT02725866
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
  • Paritaprevir/ritonavir/ombitasvir
  • Dasabuvir
  • Ribavirin
    • Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 99 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Treatment-naïve or -experienced adult male or female participants with confirmed chronic hepatitis C (CHC), genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) according to standard of care and in line with the current local label * If RBV was co-administered with the ABBVIE REGIMEN, it had to be prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy) * Participants had to voluntarily sign and date an informed consent form prior to inclusion into the study * Participant must not have participated or intended to participate in a concurrent interventional therapeutic trial
    Exclusion Criteria:
    * None

    Protocol Summary

    The interferon-free combination regimen of paritaprevir/ritonavir/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 the local label, under real-world conditions in Greece in a clinical practice patient population.

    Study Locations

    No locations found.