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

Study Identifier
P16-014
CT.gov Identifier
NCT02803138
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
Available Language(s): English
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Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • Ombitasvir/paritaprevir/ritonavir
  • Dasabuvir
  • Ribavirin
    • 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 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 * Participants 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 ombitasvir/paritaprevir/ritonavir/ 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 was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in Israel in a clinical practice patient population.

    Study Locations

    Location
    Status
    Location
    Soroka Medical Center /ID# 169357
    Beersheba, Southern District, Israel, 84101
    Status
    Not applicable
    Location
    Rabin Medical Center /ID# 153696
    Petakh Tikva, Tel Aviv, Israel, 4941492
    Status
    Not applicable
    Location
    Rabin Medical Center /ID# 158648
    Petakh Tikva, Tel Aviv, Israel, 4941492
    Status
    Not applicable
    Location
    Tel Aviv Sourasky Medical Ctr /ID# 153693
    Tel Aviv, Tel Aviv, Israel, 6423906
    Status
    Not applicable
    Location
    Ha'Emek Medical Center /ID# 153695
    Afula, Israel, 18341
    Status
    Not applicable
    Location
    Soroka Medical Ctr /ID# 153697
    Beersheba, Israel, 84101
    Status
    Not applicable
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