Interferon α 2b Pharmacovigilance Study

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT01841775

Collaborator

Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital) (Other), Hospital Universitário Clementino Fraga Filho (Other)

Enrollment

Locations

Duration (Months)

42.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: interferon α 2b + ribavirin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Outcome Measures

Primary Outcome Measures

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

Sustained virological response [24 weeks after finishing treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)	Rio de Janeiro	RJ	Brazil	21941-913
2	Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)	Rio de Janeiro		Brazil	21041-030

Sponsors and Collaborators

The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)
Hospital Universitário Clementino Fraga Filho

Investigators

Principal Investigator: Eliane M. dos Santos, MD, MSc, The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Study Director: Paulo Roberto G. dos Santos, PharmD, MSc, The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Study Director: Deborah A. da Conceição, BScN, The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)