Interferon α 2b Pharmacovigilance Study

Hepatitis C, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01841775
• Other study ID #: VIGAT-RJ IFNa2b
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2013
• Last updated: April 24, 2013
• Start date: May 2009
• Est. completion date: December 2012

Study information

• Verified date: April 2013
• Source: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• interferon a 2b + ribavirin
interferon a 2b: 3.000.000 IU SUBQ 3 times / wk for 24 weeks ribavirin 250 mg: 15mg/kg/day,ORALLY twice a day for 24 weeks

Locations

Country	Name	City	State
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

Sponsors (3)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Diary for recording adverse events by patients daily; Monthly follow-up interview with MD and PharmD	Up to 24 weeks	Yes
Secondary	Sustained virological response		24 weeks after finishing treatment	No

External Links

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