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Completed

NCT Number: NCT01841775

Interferon α 2b Pharmacovigilance Study

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

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital), Rio de Janeiro, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

interferon α 2b + ribavirin

Drug
  • 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 outcomes

  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 outcomes

  1. Sustained virological response

    Time frame: 24 weeks after finishing treatment

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Hospital Federal de Bonsucesso
  • Hospital Universitário Clementino Fraga Filho

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2013
Registry last updated
Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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