MedPath

Interferon α 2b Pharmacovigilance Study

Phase 4
Completed
Conditions
Hepatitis C, Chronic
Registration Number
NCT01841775
Lead Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
85
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Adverse eventsUp to 24 weeks

* Diary for recording adverse events by patients daily;

* Monthly follow-up interview with MD and PharmD

Secondary Outcome Measures
NameTimeMethod
Sustained virological response24 weeks after finishing treatment

Trial Locations

Locations (2)

Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)

🇧🇷

Rio de Janeiro, RJ, Brazil

Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)

🇧🇷

Rio de Janeiro, Brazil

Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)
🇧🇷Rio de Janeiro, RJ, Brazil

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.