Chronic Hepatitis BNCT06596213
Hepatitis Inequalities Study
An observational study of Chronic Hepatitis B and HEPATITIS C VIRUS CHRONIC INFECTION, run by Chinese University of Hong Kong.
Trial summary
Health inequality in liver diseases including age, gender, ethnicity and socioeconomic status has been increasingly recognised and potentially hinder hepatitis elimination. Health inequality has significant impact to evaluate the impact diagnostic and treatment uptake rates of chronic viral hepatitis on risk of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B, HEPATITIS C VIRUS CHRONIC INFECTION
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: From the Clinical Data Analysis and Reporting System (CDARS) from Hospital Authority
Who may be able to join
- Patients will be eligible if they have any of these viral markers (HBeAg / HBsAg / HBV DNA / HCV RNA) and/or any of the following diagnosis codes (ICD-9 070-070.9; 348.3, 349.82, 456, 456.2, 456.8, 567.2, 567.8, 570, 571.2, 571.5, 571.6, 572.2, 572.3, 572.4, 789.5) checked or coded in any public hospitals or clinics from 1 January 2000 to 31 March 2024.
Who cannot join
- Patients with missing age, gender, ethnicity and socioeconomic status
- (Subgroup analysis for ethnicity and socioeconomic status) Patients with missing ethnicity and socioeconomic status
- Serious medical illnesses or malignancy with life expectancy \<1 year
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Overcoming Inequalities in Health to Eliminate Hepatitis - Real-World Evidence from a Territory-Wide Cohort
Health inequality in liver diseases including age, gender, ethnicity and socioeconomic status has been increasingly recognised and potentially hinder hepatitis elimination. Health inequality has significant impact to evaluate the impact diagnostic and treatment uptake rates of chronic viral hepatitis on risk of hepatocellular carcinoma (HCC), hepatic event and liver-related death in patients with chronic hepatitis B and/or C. To overcome the limitation of small prospective cohort study of limited recruitment period, retrieving information from the Clinical Data Analysis and Reporting System (CDARS) from Hospital Authority (HA) will be one of the best way to answer these questions.
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Time from diagnosis of hepatitis to treatment.
Measured: From 1 January 2000 to 31 March 2024
Secondary outcomes (1)
Safety
The composite endpoints of recurrence of hepatic events (e.g. HCC hepatic coma, portal hypertension, variceal bleeding, hepatorenal syndrome).
Measured: From 1 January 2000 to 31 March 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grace Lai Hung Wong, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596213
- Sponsor's protocol ID
- CRE2024.361
- Status last verified
- Jul 2024
- First submitted
- 11 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012 May;142(6):1264-1273.e1. doi: 10.1053/j.gastro.2011.12.061.
PubMed 22537432
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Inequalities in Health to Eliminate Hepatitis - Real-World Evidence from a Territory-Wide Cohort
- ClinicalTrials.gov ID
- NCT06596213
- Acronym / sponsor ID
- CRE2024.361
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
Health inequality in liver diseases including age, gender, ethnicity and socioeconomic status has been increasingly recognised and potentially hinder hepatitis elimination. Health inequality has significant impact to evaluate the impact diagnostic and treatment uptake rates of chronic viral hepatitis on risk of hepatocellular carcinoma (HCC), hepatic event and liver-related death in patients with chronic hepatitis B and/or C. To overcome the limitation of small prospective cohort study of limited recruitment period, retrieving information from the Clinical Data Analysis and Reporting System (CDARS) from Hospital Authority (HA) will be one of the best way to answer these questions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From the Clinical Data Analysis and Reporting System (CDARS) from Hospital Authority
Key inclusion criteria (1 listed)
- Patients will be eligible if they have any of these viral markers (HBeAg / HBsAg / HBV DNA / HCV RNA) and/or any of the following diagnosis codes (ICD-9 070-070.9; 348.3, 349.82, 456, 456.2, 456.8, 567.2, 567.8, 570, 571.2, 571.5, 571.6, 572.2, 572.3, 572.4, 789.5) checked or coded in any public hospitals or clinics from 1 January 2000 to 31 March 2024.
Key exclusion criteria (3 listed)
- Patients with missing age, gender, ethnicity and socioeconomic status
- (Subgroup analysis for ethnicity and socioeconomic status) Patients with missing ethnicity and socioeconomic status
- Serious medical illnesses or malignancy with life expectancy \<1 year
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
Safety
Time frame: From 1 January 2000 to 31 March 2024
Time from diagnosis of hepatitis to treatment.
1 secondary outcome
Safety
Time frame: From 1 January 2000 to 31 March 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 22537432El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012 May;142(6):1264-1273.e1. doi: 10.1053/j.gastro.2011.12.061.
- Hepatitis BLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B and HEPATITIS C VIRUS CHRONIC INFECTION, run by Chinese University of Hong Kong.
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 3 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angel Chim, MSc (852-35053759, angelchim@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: From 1 January 2000 to 31 March 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06596213, which also lists 1 linked publication.
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 19 Sep 2024.