NCT00512941

Brief Summary

Chronic hepatitis by the B virus (HBV) and/or by the C virus (HCV) 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 that the number of HBV is two million, of which 72 thousand have been reported. As regards HCV, the ratio is one of three million estimated cases to 52 thousand reports. Learning about the serological profile of the users of a viral hepatitis reference service is fundamental for the planning of diagnostic and caregiving actions; therefore, it is the objective of this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
531

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

June 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
Last Updated

September 5, 2008

Status Verified

September 1, 2008

First QC Date

August 6, 2007

Last Update Submit

September 4, 2008

Conditions

Hepatitis, Viral, Non-A, Non-B, Parenterally-TransmittedHepatitis B, Chronic

Study Arms (7)

1

HBV: Carrier

2

HBV: cure

3

HBV: isolate anti-HBc

4

HBV: vaccinated

5

HCV: anti-HCV positive test

6

HBV/HCV co-infection

7

Susceptible individuals

Eligibility Criteria

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

Patients with laboratory tests positive for hepatitis B and/or C

You may qualify if:

  • Patients with laboratory tests positive for hepatitis B and/or C

You may not qualify if:

  • No laboratory tests available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SAE e Hospital Dia de Aids

Botucatu, São Paulo, 18618970, Brazil

Location

SAE e Hospital Dia

Botucatu, São Paulo, 18618970, Brazil

Location

MeSH Terms

Conditions

Hepatitis CHepatitis B, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis BHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexandre N Barbosa, MD, MSc

    SAE e Hospital Dia de Aids

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 8, 2007

Study Start

June 1, 2007

Study Completion

August 1, 2007

Last Updated

September 5, 2008

Record last verified: 2008-09

Locations

BR(2)