Interferon α 2b Pharmacovigilance Study

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter prospective follow-up of a not controlled chronic hepatitis C genotypes 2/3 patients cohort with treatment indication with interferon α 2b and ribavirin for 24 weeks, and the verification of sustained virological response at week 48.

The eligibility criteria and outcome measures followed the Clinical Protocol and Therapeutic Guidelines for Chronic Viral Hepatitis C, published by the Ministry of Health:

http://portal.saude.gov.br/portal/arquivos/pdf/pcdt_hepatite_c_2011_retificado.pdf

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Collaborators: Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital); Hospital Universitário Clementino Fraga Filho; Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)
• Treatments: Interferons; Ribavirin

Criteria

Inclusion Criteria:

• Genotype 2/3 Chronic Hepatitis C confirmed by biomolecular technology (RNAVHC);

• Treatment naive;

• Signing the Informed Consent Form;

• Eligibility criteria and outcome measures followed the Clinical Protocol and Therapeutic Guidelines for Chronic Viral Hepatitis C, published by the Ministry of Health: http://portal.saude.gov.br/portal/arquivos/pdf/pcdt_hepatite_c_2011_retificado.pdf

Exclusion Criteria:

• Serious adverse events;

• Intolerance to treatment;

• Lost to follow up.