NCT00514111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 20, 2009

Status Verified

March 1, 2009

Enrollment Period

11 months

First QC Date

August 8, 2007

Last Update Submit

March 19, 2009

Conditions

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

Study Arms (1)

HVC Patients

HVC patients attended in SAE e HD.

Drug: pegylated-interferon, conventional-interferon, ribavirin

Interventions

pegylated-interferon, conventional-interferon, ribavirinDRUG

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

Also known as: Pegasys, PegIntron, Ribavirin
HVC Patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HVC patients attended in SAE e HD.

You may qualify if:

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

You may not qualify if:

  • No HVC infection or treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SAE e Hospital Dia de Aids

Botucatu, São Paulo, 18618970, Brazil

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Ribavirinpeginterferon alfa-2apeginterferon alfa-2b

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Alexandre N Barbosa, MD, MSc

    UPECLIN HC FM Botucatu Unesp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2007

First Posted

August 9, 2007

Study Start

August 1, 2007

Primary Completion

July 1, 2008

Study Completion

December 1, 2008

Last Updated

March 20, 2009

Record last verified: 2009-03

Locations

BR(1)