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Interferon α 2b Pharmacovigilance Study

NCT01841775 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2013-04-29

No results posted yet for this study

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

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

interferon α 2b + ribavirin

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

Sponsors & Collaborators

  • Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)

    collaborator UNKNOWN

  • Hospital Universitário Clementino Fraga Filho

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Eliane M. dos Santos, MD, MSc · The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

  • Paulo Roberto G. dos Santos, PharmD, MSc · The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

  • Deborah A. da Conceição, BScN · The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01841775 on ClinicalTrials.gov