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

Study Identifier
P16-024
CT.gov Identifier
NCT02851069
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
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, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) ± ribavirin (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). * Participant must not be participating or intending to participate in a concurrent interventional therapeutic trial.
    Exclusion Criteria:
    \- None

    Protocol Summary

    This is a prospective, multi-center observational study in adult participants chronically infected with hepatitis C virus (HCV) receiving the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir with or without dasabuvir) with or without ribavirin (RBV). The prescription of a treatment regimen was at the discretion of the physician in accordance with local clinical practice and label.

    This study focused on collecting real world data. Follow-up visits, treatment, procedures and diagnostic methods followed physicians' routine clinical practice using a 12-week treatment regimen (four visits plus two interim data collection windows) or a 24-week treatment regimen (four visits plus three interim data collection windows) and is based on the anticipated regular follow-up for patients undergoing treatment for chronic hepatitis C (CHC). Participants are observed for the duration of the ABBVIE REGIMEN therapy and for up to 24 weeks after treatment completion.

    Study Locations

    Location
    Status
    Location
    Fundacion Cardioinfantil
    Bogotá, Colombia
    Status
    Not applicable
    Location
    Cic Cali
    Cali, Colombia, 760001
    Status
    Not applicable
    Location
    Centro Medico lmbanaco de Cali I
    Cali, Colombia
    Status
    Not applicable
    Location
    Pharos Centro de Estudios Clin
    Cartagena, Colombia, 130013
    Status
    Not applicable
    Location
    IPS Medicos Internistas Del Ca I
    Manizales, Colombia, 170004
    Status
    Not applicable
    Location
    Fundacion Hospitalaria San Vin
    Medellín, Colombia, 050010
    Status
    Not applicable