Interferon α 2b Pharmacovigilance Study

NCT01841775 | Completed Phase 4 DMC

• 1 other identifier: VIGAT-RJ IFNα2b
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

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

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C, Chronic; Genotype 2/3; Interferon α 2b; Ribavirin; Pharmacovigilance

Outcome Measures

Primary Outcomes (1)

• Adverse events

  * Diary for recording adverse events by patients daily; * Monthly follow-up interview with MD and PharmD

  Up to 24 weeks

Secondary Outcomes (1)

• Sustained virological response

  24 weeks after finishing treatment

Interventions

interferon α 2b + ribavirin DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Serious adverse events;
• Intolerance to treatment;
• Lost to follow up.

Sponsors & Collaborators

• The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz): lead
• Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital): collaborator
• Hospital Universitário Clementino Fraga Filho: collaborator

Study Sites (2)

Hospital Federal de Bonsucesso (Bonsucesso Federal Hospital)

Rio de Janeiro, Rio de Janeiro, 21041-030, Brazil

Location

Hospital Universitário Clementino Fraga Filho (Clementino Fraga Filho University Hospital)

Rio de Janeiro, Rio de Janeiro, 21941-913, Brazil

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Eliane M. dos Santos, MD, MSc

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

  PRINCIPAL INVESTIGATOR

• Paulo Roberto G. dos Santos, PharmD, MSc

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

  STUDY DIRECTOR

• Deborah A. da Conceição, BScN

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: April 29, 2013
• Study Start: May 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 29, 2013

Record last verified: 2013-04

Locations

BR (2)