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Interferon α 2b Pharmacovigilance Study

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
interferon α 2b + ribavirin
Sponsored by
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, Chronic, Genotype 2/3, Interferon α 2b, Ribavirin, Pharmacovigilance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Adverse events
Diary for recording adverse events by patients daily; Monthly follow-up interview with MD and PharmD

Secondary Outcome Measures

Sustained virological response

Full Information

First Posted
April 19, 2013
Last Updated
April 24, 2013
Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators
Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital), Hospital Universitário Clementino Fraga Filho
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1. Study Identification

Unique Protocol Identification Number
NCT01841775
Brief Title
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

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborators
Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital), Hospital Universitário Clementino Fraga Filho

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, Chronic, Genotype 2/3, Interferon α 2b, Ribavirin, Pharmacovigilance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
interferon α 2b + ribavirin
Intervention Description
interferon α 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
Primary Outcome Measure Information:
Title
Adverse events
Description
Diary for recording adverse events by patients daily; Monthly follow-up interview with MD and PharmD
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Sustained virological response
Time Frame
24 weeks after finishing treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliane M. dos Santos, MD, MSc
Organizational Affiliation
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo Roberto G. dos Santos, PharmD, MSc
Organizational Affiliation
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Deborah A. da Conceição, BScN
Organizational Affiliation
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)
City
Rio de Janeiro
ZIP/Postal Code
21041-030
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.bio.fiocruz.br
Description
Related Info

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Interferon α 2b Pharmacovigilance Study

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