We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Factors Associated to Success of Hepatitis C Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00514111
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : March 20, 2009
Sponsor:
Information provided by:

Study Description
Brief 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.

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

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.

Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Factors Associated to Success of Hepatitis C Therapy
Study Start Date : August 2007
Primary Completion Date : July 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 9, 2007    Key Record Dates
Last Update Posted: March 20, 2009
Last Verified: March 2009

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
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action