Interferon α 2b Pharmacovigilance Study

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: interferon α 2b + ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01841775

VIGAT-RJ IFNα2b

Details and patient eligibility

About

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

Enrollment: 85 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)