Chronic Hep BNCT04904900
Prospective Evaluation of a Fast-track Treatment Pathway for Patients With Chronic Hepatitis B Under Primary Care
An observational study of Chronic Hep B, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a retrospective-prospective longitudinal cohort study, with analyses performed before and after introduction of the pathway, and comparisons made to unexposed controls. We will launch a protocol-driven management for CHB patients, and provide the appropriate assessment tools (transient elastography, HBV DNA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hep B
- How many people
- 3,300 participants
- Where
- 1 siteHong Kong
- Study dates
- 6 May 2021to 31 Dec 2025
- 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: 300 prospectively from FM/GOPC 3000 retrospectively from CDARS.
Who may be able to join
- Adult patients with positive hepatitis B surface antigen (HBsAg) for 6 months
- Under the care of GOPC
Who cannot join
- Age under 18
- Refusal to consent
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Angel Chim, angelchim@cuhk.edu.hk
About this study
This is a retrospective-prospective longitudinal cohort study, with analyses performed before and after introduction of the pathway, and comparisons made to unexposed controls. We will launch a protocol-driven management for CHB patients, and provide the appropriate assessment tools (transient elastography, HBV DNA assay) to general outpatient clinics (GOPC) in Hong Kong. Patients who fulfil treatment criteria will be referred to specialist outpatient clinics (SOPC) in a fast-track manner. We will also evaluate the linkage-to-care rate 3 years before the launch of this care pathway retrospectively.
Read the detailed description
Chronic viral hepatitis is the seventh leading cause of mortality globally, responsible for 1.45 million deaths in 2013. The consequences of chronic hepatitis B and C infection - cirrhosis and liver cancer - account for 94% of deaths associated with hepatitis.1 Liver cancer is the second most common cause of cancer death in the Asia-Pacific region. Approximately 78% of liver cancer cases are a result of chronic viral hepatitis.1,2 In Hong Kong, the positive rate of hepatitis B surface antigen (HBsAg) remains high among adults of productive ages of 31-40 and 41-50 years (5.2% and 7.2% respectively) in 2015.3 World Health Organization (WHO) published the first global health sector strategy on viral hepatitis in June 2016, a strategy that contributes to the proposed targets for the reduction of chronic viral hepatitis incidence and mortality of 90% and 65% respectively by 2030.4 The Chief Executive's 2017 Policy Address in Hong Kong asked to set up the Steering Committee to formulate strategies to effectively prevent and control viral hepatitis.5 The Steering Committee is currently reviewing local and international trends and developments in the prevention and control of viral hepatitis; advising the Government on policies and cost-effective targeted strategies for prevention and control of viral hepatitis; and conducting and coordinating the surveillance and evaluation of viral hepatitis control and recommending appropriate response.5 One of the key gaps in CHB management is the suboptimal treatment in patients who fulfil treatment criteria but not started on antiviral treatment because of linkage-to-care issue, namely very long waiting time (up to 2.5 years) from primary care setting like general outpatient clinics (GOPC). There are limited resources for specialized assessments (e.g. HBV DNA assays, transient elastography for liver fibrosis assessment).
Therefore a novel fast-track treatment pathway for patients with chronic hepatitis B under primary care would fill this gap and provide pivotal data to the Government and the Steering Committee to guide the strategies for achieving the goals set by WHO.
- Conditions
- Chronic Hep B
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage-to-care
referral rate of patients from GOPC and SOPC who fulfil treatment criteria
Measured: 3 years
Secondary outcomes (3)
Unnecessary referral
referral rate of patients from GOPC and SOPC who do not fulfil treatment criteria
Measured: 3 years
GOPC care management rate
transient elastography uptake rate, fibrosis staging, clinical events, default rate
Measured: 3 years
SOPC care management rate
antiviral uptake care, fibrosis staging, clinical events, default rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start6 May 2021
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (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 Hep 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
- Prospective
- Enrolment
- 3,300 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
- Investigators
- Grace LH Wong, Prof, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904900
- Sponsor's protocol ID
- HBV_GOPC study
- Status last verified
- Sep 2023
- First submitted
- 20 May 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sarin SK, Kumar M, Lau GK, Abbas Z, Chan HL, Chen CJ, Chen DS, Chen HL, Chen PJ, Chien RN, Dokmeci AK, Gane E, Hou JL, Jafri W, Jia J, Kim JH, Lai CL, Lee HC, Lim SG, Liu CJ, Locarnini S, Al Mahtab M, Mohamed R, Omata M, Park J, Piratvisuth T, Sharma BC, Sollano J, Wang FS, Wei L, Yuen MF, Zheng SS, Kao JH. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016 Jan;10(1):1-98. doi: 10.1007/s12072-015-9675-4. Epub 2015 Nov 13.
PubMed 26563120
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Fast-track Treatment Pathway for Patients With Chronic Hepatitis B Under Primary Care
- ClinicalTrials.gov ID
- NCT04904900
- Acronym / sponsor ID
- HBV_GOPC study
- Conditions
- Chronic Hep B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,300 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 6 May 2021 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 May 2021 (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.
This is a retrospective-prospective longitudinal cohort study, with analyses performed before and after introduction of the pathway, and comparisons made to unexposed controls. We will launch a protocol-driven management for CHB patients, and provide the appropriate assessment tools (transient elastography, HBV DNA assay) to general outpatient clinics (GOPC) in Hong Kong. Patients who fulfil treatment criteria will be referred to specialist outpatient clinics (SOPC) in a fast-track manner. We will also evaluate the linkage-to-care rate 3 years before the launch of this care pathway retrospectively.
Detailed description
Chronic viral hepatitis is the seventh leading cause of mortality globally, responsible for 1.45 million deaths in 2013. The consequences of chronic hepatitis B and C infection - cirrhosis and liver cancer - account for 94% of deaths associated with hepatitis.1 Liver cancer is the second most common cause of cancer death in the Asia-Pacific region. Approximately 78% of liver cancer cases are a result of chronic viral hepatitis.1,2 In Hong Kong, the positive rate of hepatitis B surface antigen (HBsAg) remains high among adults of productive ages of 31-40 and 41-50 years (5.2% and 7.2% respectively) in 2015.3 World Health Organization (WHO) published the first global health sector strategy on viral hepatitis in June 2016, a strategy that contributes to the proposed targets for the reduction of chronic viral hepatitis incidence and mortality of 90% and 65% respectively by 2030.4 The Chief Executive's 2017 Policy Address in Hong Kong asked to set up the Steering Committee to formulate strategies to effectively prevent and control viral hepatitis.5 The Steering Committee is currently reviewing local and international trends and developments in the prevention and control of viral hepatitis; advising the Government on policies and cost-effective targeted strategies for prevention and control of viral hepatitis; and conducting and coordinating the surveillance and evaluation of viral hepatitis control and recommending appropriate response.5 One of the key gaps in CHB management is the suboptimal treatment in patients who fulfil treatment criteria but not started on antiviral treatment because of linkage-to-care issue, namely very long waiting time (up to 2.5 years) from primary care setting like general outpatient clinics (GOPC). There are limited resources for specialized assessments (e.g. HBV DNA assays, transient elastography for liver fibrosis assessment).
Therefore a novel fast-track treatment pathway for patients with chronic hepatitis B under primary care would fill this gap and provide pivotal data to the Government and the Steering Committee to guide the strategies for achieving the goals set by WHO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 prospectively from FM/GOPC 3000 retrospectively from CDARS.
Key inclusion criteria (2 listed)
- Adult patients with positive hepatitis B surface antigen (HBsAg) for 6 months
- Under the care of GOPC
Key exclusion criteria (2 listed)
- Age under 18
- Refusal to consent
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
Linkage-to-care
Time frame: 3 years
referral rate of patients from GOPC and SOPC who fulfil treatment criteria
3 secondary outcomes
Unnecessary referral
Time frame: 3 years
GOPC care management rate
Time frame: 3 years
SOPC care management rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Background: PubMed 26563120Sarin SK, Kumar M, Lau GK, Abbas Z, Chan HL, Chen CJ, Chen DS, Chen HL, Chen PJ, Chien RN, Dokmeci AK, Gane E, Hou JL, Jafri W, Jia J, Kim JH, Lai CL, Lee HC, Lim SG, Liu CJ, Locarnini S, Al Mahtab M, Mohamed R, Omata M, Park J, Piratvisuth T, Sharma BC, Sollano J, Wang FS, Wei L, Yuen MF, Zheng SS, Kao JH. Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update. Hepatol Int. 2016 Jan;10(1):1-98. doi: 10.1007/s12072-015-9675-4. Epub 2015 Nov 13.
- Hepatitis BLink provided by the sponsor.
- Hepatitis CLink provided by the sponsor.
- Surveillance of Viral Hepatitis in Hong Kong - 2016 Update ReportLink provided by the sponsor.
- Combating hepatitis B and C to reach elimination by 2030Link provided by the sponsor.
- Building a Caring, Inclusive Society, Improving People's LivelihoodLink 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. This study is not recruiting at the moment.
Grace LH Wong, Prof principal investigator
Chinese University of Hong Kong
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 Chronic Hep B, run by Chinese University of Hong Kong at 1 site in 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Angel Chim, MSc (+852 3505 4205, angelchim@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage-to-care (time frame: 3 years). 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 NCT04904900, 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 13 Sep 2023.