Interferon α 2b Pharmacovigilance Study
- Conditions
- Hepatitis C, Chronic
- Registration Number
- NCT01841775
- Lead Sponsor
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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
- Serious adverse events;
- Intolerance to treatment;
- Lost to follow up.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Adverse events Up to 24 weeks * Diary for recording adverse events by patients daily;
* Monthly follow-up interview with MD and PharmD
- Secondary Outcome Measures
Name Time Method Sustained virological response 24 weeks after finishing treatment
Trial Locations
- Locations (2)
Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)
🇧🇷Rio de Janeiro, RJ, Brazil
Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)
🇧🇷Rio de Janeiro, Brazil
Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)🇧🇷Rio de Janeiro, RJ, Brazil