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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01841775

Enrollment

Registered

2013-04-29

Start date

2009-05-31

Completion date

2012-12-31

Last updated

2013-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic, Genotype 2/3, Interferon α 2b, Ribavirin, Pharmacovigilance

Brief 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

Interventions

DRUGinterferon 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse events	Up to 24 weeks	* Diary for recording adverse events by patients daily; * Monthly follow-up interview with MD and PharmD

Secondary

Measure	Time frame
Sustained virological response	24 weeks after finishing treatment

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026