Trial | NCT01841775  Report issue

Title

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)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    85
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
Study Started
May 31
2009
Primary Completion
Sep 30
2012
Study Completion
Dec 31
2012
Last Update
Apr 29
2013
Estimate

Drug interferon α 2b + ribavirin

interferon α 2b: 3.000.000 IU SUBQ 3 times / wk for 24 weeks ribavirin 250 mg: 15mg/kg/day,ORALLY twice a day for 24 weeks

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.
No Results Posted