Status:
TERMINATED
ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Brief Summary
This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordanc...
Detailed Description
This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordanc...
Eligibility Criteria
Inclusion
- Must have confirmed his/her willingness in participating in this study, after having been informed of all aspects that are pertinent to his/her decision to participate, by signing and dating the informed consent form (ICF) approved by the Institutional Review Board / Independent Ethics Committee on Research (IRB/IEC).
- Adult patients who are 18 years old or above.
- Must have diagnosis of chronic hepatitis C confirmed through positive qualitative or quantitative PCR (polymerase chain reaction) performed prior to initiation of the patient's treatment. This result shall be documented in the patient's records.
- Must have completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin.
- Patients who started treatment for chronic hepatitis C from the year 2008 or later.
Exclusion
- Does not confirm his/her willing in participating in this study or refuses to sign the informed consent form.
- Did not start the treatment with peginterferon alfa-2b and ribavirin.
- Patients who have less than 12 weeks of treatment with peginterferon alfa-2b and ribavirin.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
902 Patients enrolled
Trial Details
Trial ID
NCT00856024
Start Date
July 1 2008
End Date
October 1 2010
Last Update
July 1 2015
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