Clinical trial NCT01841775: Interferon α 2b Pharmacovigilance Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic
Genotype 2/3
Interferon α 2b
Ribavirin
Pharmacovigilance
Lead sponsor: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Sponsor class: OTHER
Collaborators: name: Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)
name: Hospital Universitário Clementino Fraga Filho
First posted: 2013-04-29
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Adverse events
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Sustained virological response
timeFrame: 24 weeks after finishing treatment
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)
Study officials:
affiliation: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
name: Eliane M. dos Santos, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
name: Paulo Roberto G. dos Santos, PharmD, MSc
role: STUDY_DIRECTOR
affiliation: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
name: Deborah A. da Conceição, BScN
role: STUDY_DIRECTOR
References: