Factors Associated to Success of Hepatitis C Therapy

NCT ID: NCT00514111

Last Updated: 2009-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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HVC Patients

HVC patients attended in SAE e HD.

pegylated-interferon, conventional-interferon, ribavirin

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Pegasys PegIntron Ribavirin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No HVC infection or treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UPECLIN HC FM Botucatu Unesp

OTHER

Sponsor Role lead

Responsible Party

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SAE e Hospital Dia de Aids - Faculdade de Medicina de Botucatu - Unesp

Principal Investigators

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Alexandre N Barbosa, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

UPECLIN HC FM Botucatu Unesp

Locations

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SAE e Hospital Dia de Aids

Botucatu, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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upeclin/HC/FMB-Unesp-16

Identifier Type: -

Identifier Source: org_study_id

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