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

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-04
• Study First Submitted: 2013-04-19
• Study First Submitted QC: 2013-04-24
• Last Update Submitted: 2013-04-24
• Study First Posted: 2013-04-29
• Last Update Posted: 2013-04-29

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

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

Secondary Outcome Measures

Name	Time	Method
Sustained virological response	24 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