Hepatitis, Viral, Non-A, Non-B, Parenterally-TransmittedNCT00512941
Laboratory Profile of Hepatitis B and C in Users of a Reference Service
An observational study of Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted and Hepatitis B, Chronic, run by UPECLIN HC FM Botucatu Unesp at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted, Hepatitis B, Chronic
- Type of treatment
- Vaccines
- How many people
- 531 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2007to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with laboratory tests positive for hepatitis B and/or C
Who may be able to join
- Patients with laboratory tests positive for hepatitis B and/or C
Who cannot join
- No laboratory tests available
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
SAE e Hospital Dia de Aids
Botucatu, São Paulo, 18618970
SAE e Hospital Dia
Botucatu, São Paulo, 18618970
About this study
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.
Read the 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.
- Medical subject headings
- Hepatitis C, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study startJun 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, Viral, Non-A, Non-B, Parenterally-TransmittedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Alexandre N Barbosa, MD, MSc, Principal investigator, SAE e Hospital Dia de Aids
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512941
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-15
- Status last verified
- Sep 2008
- First submitted
- 6 Aug 2007
- Last updated
- 5 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laboratory Profile of Hepatitis B and C in Users of a Reference Service
- ClinicalTrials.gov ID
- NCT00512941
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-15
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with laboratory tests positive for hepatitis B and/or C
Key inclusion criteria (1 listed)
- Patients with laboratory tests positive for hepatitis B and/or C
Key exclusion criteria (1 listed)
- No laboratory tests available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2008.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre N Barbosa, MD, MSc principal investigator
SAE e Hospital Dia de Aids
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted and Hepatitis B, Chronic, run by UPECLIN HC FM Botucatu Unesp at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2008.