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Factors Associated to Success of Hepatitis C Therapy

This study has been completed.
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp
ClinicalTrials.gov Identifier:
NCT00514111
First received: August 8, 2007
Last updated: March 19, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted
 Drug: pegylated-interferon, conventional-interferon, ribavirin
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Associated to Success of Hepatitis C Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UPECLIN HC FM Botucatu Unesp:

Enrollment: 100
Study Start Date: August 2007
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HVC Patients
HVC patients attended in SAE e HD.
 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.
Other Names:
  • Pegasys
  • PegIntron
  • Ribavirin

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

HVC patients attended in SAE e HD.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No HVC infection or treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514111

Locations
Brazil
SAE e Hospital Dia de Aids
Botucatu, Sao Paulo, Brazil, 18618970
Sponsors and Collaborators
UPECLIN HC FM Botucatu Unesp
Investigators
Principal Investigator: Alexandre N Barbosa, MD, MSc UPECLIN HC FM Botucatu Unesp
  More Information

No publications provided

Responsible Party: Alexandre Naime Barbosa, SAE e Hospital Dia de Aids - Faculdade de Medicina de Botucatu - Unesp
ClinicalTrials.gov Identifier: NCT00514111     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-16
Study First Received: August 8, 2007
Last Updated: March 19, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013