Laboratory Profile of Hepatitis B and C in Users of a Reference Service

NCT ID: NCT00512941

Last Updated: 2008-09-05

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

531 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-08-31

Brief Summary

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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.

Detailed Description

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

Five hundred and thirty-one HVB and HVC serological profiles of the patients referred to SAE/HD within a period of 18 months (January 2006 to June 2007) were studied by means of retrospective analysis. The patients were classified as: a) HBV: carrier, cure, isolated anti-HBc and vaccinated; b) HVC: reagent anti-HVC; c) HBV/HVC co-infection: AgHBs and reagent anti-HVC; and d) Susceptible: non-reagent serology.

As regards HBV, the following were found from the total number of patients: carriers, 12.6%; cure, 18.9%; isolated anti-HBc, 9.0% and vaccinated, 6.2%. The patients with reagent anti-HVC comprised 31.3% of the total number of individuals. HBV/HCV co-infection was 0.6%. Susceptible individuals comprised 20.5%.

It was concluded that approximately 45% of the referred patients carried chronic infection by B and/or C virus, a condition which requires additional investigation and, in many instances, specific treatment. Strategies for early diagnosis are essential in order to prevent the intrinsic complications of such condition.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

HBV: Carrier

No interventions assigned to this group

2

HBV: cure

No interventions assigned to this group

3

HBV: isolate anti-HBc

No interventions assigned to this group

4

HBV: vaccinated

No interventions assigned to this group

5

HCV: anti-HCV positive test

No interventions assigned to this group

6

HBV/HCV co-infection

No interventions assigned to this group

7

Susceptible individuals

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No laboratory tests available
Minimum Eligible Age

18 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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Faculdade de Medicina de Botucatu - Unesp

Principal Investigators

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Alexandre N Barbosa, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

SAE e Hospital Dia de Aids

Locations

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SAE e Hospital Dia de Aids

Botucatu, São Paulo, Brazil

Site Status

SAE e Hospital Dia

Botucatu, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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upeclin/HC/FMB-Unesp-15

Identifier Type: -

Identifier Source: org_study_id