Status:
COMPLETED
Interferon α 2b Pharmacovigilance Study
Lead Sponsor:
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Collaborating Sponsors:
Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)
Hospital Universitário Clementino Fraga Filho
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- Serious adverse events;
- Intolerance to treatment;
- Lost to follow up.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01841775
Start Date
May 1 2009
End Date
December 1 2012
Last Update
April 29 2013
Active Locations (2)
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1
Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)
Rio de Janeiro, Rio de Janeiro, Brazil, 21041-030
2
Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)
Rio de Janeiro, Rio de Janeiro, Brazil, 21941-913