drugset / Trial / NCT01841775
Interferon α 2b Pharmacovigilance Study
Phase 4
Completed
85 enrolled
The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Hospital Federal de Bonsucesso · collabHospital Universitário Clementino Fraga Filho · collab
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2009-05
- Primary completion
- 2012-09
- Completion
- 2012-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ribavirin | Small molecule | 15 mg/kg | Oral |
| Subject | interferon alfa-2b | Protein / enzyme biologic | 3e+06 iu | Subcutaneous |