NCT01841775

Interferon α 2b Pharmacovigilance Study

Pharmacovigilance Study of the Interferon α 2b Produced by Bio-Manguinhos / Fiocruz and Used by Genotype 2/3 Chronic Hepatitis C Patients (Estudo de farmacovigilância da Alfainterferona 2b Humana Recombinante Produzida Por Bio-Manguinhos - Fiocruz, Utilizada em Portadores de Hepatite C crônica genótipos 2 e 3 Atendidos Pelo Programa de Medicamentos de Dispensação em Caráter Excepcional no Estado do Rio de Janeiro)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	interferon α 2b + ribavirin	1. interferon α 2b: 3.000.000 IU SUBQ 3 times / wk for 24 weeks 2. ribavirin 250 mg: 15mg/kg/day,ORALLY twice a day for 24 weeks

Timeline

• Start date: 2009-05-01
• Primary completion: 2012-09-01
• Completion: 2012-12-01
• First posted: 2013-04-29
• Last updated: 2013-04-29

Locations

2 sites across 1 country: Brazil