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

NCT00856024 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 902

Last updated 2015-07-01

Study results available
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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.

Conditions

  • Hepatitis C, Chronic

Interventions

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.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-10-31
Completion
2010-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00856024 on ClinicalTrials.gov