Real World Evidence of the Effectiveness of Paritaprevir/Ritonavir (r) - Ombitasvir, + Dasabuvir Without Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis in the Russian Federation

Study Identifier
P16-253
CT.gov Identifier
NCT03053180
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:
    * 3DAA ABBVIE REGIMEN will be prescribed by physicians according to the routine clinical practice * Treatment-naïve or interferon (IFN)/ribavirin (RBV)-experienced participants with confirmed CHC Gt1b and compensated liver cirrhosis, receiving therapy with the interferon-free 3DAA ABBVIE REGIMEN initiated not earlier than 2 weeks before the enrollment or the initiation is planned not later than 2 weeks after the day of enrollment in accordance to standard of care and in line with the current local label * Participants must not be participating or intending to participate in a concurrent interventional therapeutic trial
    Exclusion Criteria:
    * Co-administration ribavirin (RBV) with the 3DAA ABBVIE REGIMEN * Participants with Child Pugh B and C cirrhosis * Participants with a history of prior direct-acting antiviral agent (DAA) therapy * Any other contraindications to the administration of 3DAA ABBVIE REGIMEN according to the label

    Protocol Summary

    This prospective, multi-center, observational study is designed to assess the real world effectiveness of paritaprevir/r - ombitasvir with dasabuvir (3DAA \[direct-acting antiviral agent\] ABBVIE REGIMEN) without ribavirin (RBV) and to describe baseline characteristics of participants with chronic hepatitis C virus (HCV) genotype 1b (GT1b) infection and compensated liver cirrhosis in Russia.

    Study Locations

    Location
    Status
    Location
    South-Ural State Med. Academy
    Chelyabinsk, Russian Federation, 454052
    Status
    Not applicable
    Location
    KOGBUZ Kirovsk Infect Hosp
    Kirov, Russian Federation, 610008
    Status
    Not applicable
    Location
    Specialized Clinical Infectiou
    Krasnodar, Russian Federation, 350000
    Status
    Not applicable
    Location
    Orenburg Regional Clinical Hos
    Orenburg, Russian Federation, 460018
    Status
    Not applicable
    Location
    LLC Medical Company
    Samara, Russian Federation, 443063
    Status
    Not applicable
    Location
    GBOU VPO Saratov state Med Uni
    Saratov, Russian Federation, 410012
    Status
    Not applicable
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