Clinical trial NCT00856024: ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632)
Official title: ATHENAS - Retrospective Analysis of Compliance to Treatment of Chronic Hepatitis C With Pegylated Interferon Alpha 2b Associated to Ribavirin Until Week 12 and Correlation With Virological Response in Brazil Health Centers
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 902
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Patients will come from approximately 65 Brazilian sites and should satisfy all inclusion criteria and none of the exclusion criteria.

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of Participants Who Were Compliant to Treatment in the First 12 Weeks
timeFrame: First 12 weeks of treatment
Secondary outcomes:
measure: Percent of Participants Who Achieved Rapid Virologic Response (RVR)
timeFrame: Week 4
measure: Percent of Participants Who Achieved Early Virologic Response (EVR)
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
References: