Interferon α 2b Pharmacovigilance Study

April 24, 2013 updated by: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21041-030
        • Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21941-913
        • Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Up to 24 weeks
  • Diary for recording adverse events by patients daily;
  • Monthly follow-up interview with MD and PharmD
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Sustained virological response
Time Frame: 24 weeks after finishing treatment
24 weeks after finishing treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

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

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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

April 19, 2013

First Submitted That Met QC Criteria

April 24, 2013

First Posted (ESTIMATE)

April 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2013

Last Update Submitted That Met QC Criteria

April 24, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIGAT-RJ IFNα2b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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