Hepatitis BNCT00946010
Investigation of Hepatitis B and Hepatitis C in Taiwan
An observational study of Hepatitis B and Hepatitis C, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to investigate the differences of genotypes of hepatitis B and hepatitis C in Taiwan. Read more about this study
- Who is it for?
- Ages 23 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Hepatitis C
- What is being tested?
- blood sampling and abdominal sonography
- How many people
- 6,228 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2008to Jan 2011
- 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 23 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People Born before 1985/01/01 who live in Taiwan are HBV or HCV pateints.
Who may be able to join
- Born before 1985/01/01
- HBV or HCV carriers
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the differences of genotypes of hepatitis B and hepatitis C in Taiwan.
Read the detailed description
The purpose of this study is investigating the differences of genotypes and DNA level or RNA level of hepatitis B and hepatitis C in Taiwan.
- Conditions
- Hepatitis B, Hepatitis C
- Being tested
- blood sampling and abdominal sonography
- Keywords
- Hepatitis B, Hepatitis C, genotype, DNA level, RNA level, Taiwan
- Medical subject headings
- Hepatitis B, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling and abdominal sonographyBiological
Also called 10cc blood sampling and abdominal sonography
10cc blood sampling and abdominal sonography
| Study group | Role | What they receive |
|---|---|---|
| 1 | Click here for more information about this study: Investigation of Hepatitis B and Hepatitis C in Taiwan Receives: Biological: blood sampling and abdominal sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
genotype and DNA level or RNA level of HBV and HCV virus
Measured: once during Mar. 2008- Jan. 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startApr 2008
- Primary completionAug 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 6,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jin-Chuan Sheu, M.D. P.H.D., Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946010
- Sponsor's protocol ID
- 200801059R
- Status last verified
- Jan 2011
- First submitted
- 1 Apr 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Hepatitis B and Hepatitis C in Taiwan
- ClinicalTrials.gov ID
- NCT00946010
- Acronym / sponsor ID
- 200801059R
- Conditions
- Hepatitis B, Hepatitis C
- Keywords
- Hepatitis B, Hepatitis C, genotype, DNA level, RNA level, Taiwan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,228 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 24 Jul 2009 (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.
The purpose of this study is to investigate the differences of genotypes of hepatitis B and hepatitis C in Taiwan.
Detailed description
The purpose of this study is investigating the differences of genotypes and DNA level or RNA level of hepatitis B and hepatitis C in Taiwan.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Biological: blood sampling and abdominal sonographyClick here for more information about this study: Investigation of Hepatitis B and Hepatitis C in Taiwan |
Who may qualify
- Ages
- 23 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People Born before 1985/01/01 who live in Taiwan are HBV or HCV pateints.
Key inclusion criteria (2 listed)
- Born before 1985/01/01
- HBV or HCV carriers
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling and abdominal sonographyAlso: 10cc blood sampling and abdominal sonography10cc blood sampling and abdominal sonography | Biological | 1 |
Primary outcome
genotype and DNA level or RNA level of HBV and HCV virus
Time frame: once during Mar. 2008- Jan. 2011
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 24 Jan 2011.
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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.
Jin-Chuan Sheu, M.D. P.H.D. study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Hepatitis C, run by National Taiwan University Hospital at 1 site in Taiwan.
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 2 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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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.
What does the primary outcome measure?
genotype and DNA level or RNA level of HBV and HCV virus (time frame: once during Mar. 2008- Jan. 2011). It is what the study was designed to measure, not a finding.
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 24 Jan 2011.