A Phase 4 interventional study of interferon α 2b + ribavirin in Hepatitis C, Chronic, sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz). Completed at 2 sites in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-04-29.
Sponsored by The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) · Phase 4, Interventional, and Treatment
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
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 85 is below the median of 100 across 1,887 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz) is the lead sponsor of 27 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Adverse events
* Diary for recording adverse events by patients daily; * Monthly follow-up interview with MD and PharmD
Time frame: Up to 24 weeks
Sustained virological response
Time frame: 24 weeks after finishing treatment
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)