Factors Associated to Success of Hepatitis C Therapy

Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted Clinical Trial

Official title:

Factors Associated to Success of Hepatitis C Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00514111
• Other study ID #: upeclin/HC/FMB-Unesp-16
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2007
• Last updated: March 19, 2009
• Start date: August 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2009
• Source: UPECLIN HC FM Botucatu Unesp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.

Description:

Chronic hepatitis C virus(HVC) is a major public-health problem since it presents a long phase of clinical latency which makes its early diagnosis difficult and results in the development of a large number of cases to complications such as cirrhosis, hepatic insufficiency and hepatocarcinoma. In Brazil, it is estimated three million estimated cases to 52 thousand reports. The aim of this study is to evaluate the sustained virologic response (RVS) in HVC patients treated with pegylated-interferon or conventional-interferon and ribavirin, and to investigate the associated factors with RVS, by means of retrospective analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• HVC patients that received specific treatment with pegylated-interferon or conventional-interferon, and ribavirin

Exclusion Criteria:

• No HVC infection or treatment

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted

Intervention

Drug:
• pegylated-interferon, conventional-interferon, ribavirin
Genotype 1: pegylated-interferon 2a or 2b plus ribavirin for 48 weeks. Genotype 3: conventional-interferon 2a or 2b plus ribavirin for 24 weeks.

Locations

Country	Name	City	State
Brazil	SAE e Hospital Dia de Aids	Botucatu	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
UPECLIN HC FM Botucatu Unesp

Country where clinical trial is conducted

Brazil,