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Interferon α 2b Pharmacovigilance Study

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ClinicalTrials.gov Identifier: NCT01841775
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : April 29, 2013
Sponsor:
Collaborators:
Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)
Hospital Universitário Clementino Fraga Filho
Information provided by (Responsible Party):
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
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 2009
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Adverse events [ Time Frame: Up to 24 weeks ]
    • Diary for recording adverse events by patients daily;
    • Monthly follow-up interview with MD and PharmD


Secondary Outcome Measures :
  1. Sustained virological response [ Time Frame: 24 weeks after finishing treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841775


Locations
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Brazil
Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)
Rio de Janeiro, RJ, Brazil, 21941-913
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
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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)

Additional Information:
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Responsible Party: The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
ClinicalTrials.gov Identifier: NCT01841775     History of Changes
Other Study ID Numbers: VIGAT-RJ IFNα2b
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: April 29, 2013
Last Verified: April 2013
Keywords provided by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz):
Hepatitis C, Chronic
Genotype 2/3
Interferon α 2b
Ribavirin
Pharmacovigilance
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Ribavirin
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action