NCT00856024

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 902 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	Peginterferon alfa-2b	PegIntron 80 μg, PegIntron 100 μg, or PegIntron 120 μg. The duration of the complete treatment and the doses of pegylated interferon alfa 2b should have been prescribed according to local guidelines, and according to the investigating physician's orientation.
DRUG	Ribavirin	Ribavirin 250 mg. The duration of the complete treatment and the doses of ribavirin should have been prescribed according to local guidelines, and according to the investigating physician's orientation.

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2009-03-05
• Last updated: 2015-07-01
• Results posted: 2011-11-28