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

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ClinicalTrials.gov Identifier: NCT00512941
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : September 5, 2008
Sponsor:
Information provided by:
UPECLIN HC FM Botucatu Unesp

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.

Condition or disease
Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted Hepatitis B, Chronic

Detailed Description:

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.


Study Type : Observational
Actual Enrollment : 531 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Laboratory Profile of Hepatitis B and C in Users of a Reference Service
Study Start Date : June 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with laboratory tests positive for hepatitis B and/or C
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No laboratory tests available

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): NCT00512941


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

Responsible Party: Sergio Muller, Faculdade de Medicina de Botucatu - Unesp
ClinicalTrials.gov Identifier: NCT00512941     History of Changes
Other Study ID Numbers: upeclin/HC/FMB-Unesp-15
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: September 5, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic