ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632)

Merck Sharp & Dohme (MSD)

Status: Terminated

Conditions: Hepatitis C, Chronic

Treatments: Biological: Peginterferon alfa-2b; Drug: Ribavirin

Study type: Observational

Funder types: Industry

Identifiers

NCT00856024

P05632

BR 002-07

Details and patient eligibility

About

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 accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The collection of data for virological response after Week 12 will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.

Full 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 accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The physician will be filling out the case report form with the information contained in the medical record. Any dose reduction and/or doses not taken during this period will be reported through the case report form. The collection of data for virological response after Week 12 (such as virological response at the end of treatment and sustained virological response after follow-up period) will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.

Enrollment: 902 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

902 participants in 3 patient groups

Group 1: Naïve patients

Description:

Patients, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b.

Treatment:

Drug: Ribavirin

Biological: Peginterferon alfa-2b

Group 2: Re-treatment

Description:

Patients, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C.

Treatment:

Drug: Ribavirin

Biological: Peginterferon alfa-2b

Group 3: HIV/HCV co-infected patients

Description:

Patients, from Brazil, with confirmed chronic hepatitis C and infected with Humman Immunodeficiency Virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin.

Treatment:

Drug: Ribavirin

Biological: Peginterferon alfa-2b