Prospective Evaluation of a Fast-track Treatment Pathway for Patients With Chronic Hepatitis B Under Primary Care

Chronic Hep B Clinical Trial

Official title:

Prospective Evaluation of a Fast-track Treatment Pathway for Patients With Chronic Hepatitis B Under Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904900
• Other study ID #: HBV_GOPC study
• Status: Recruiting
• Start date: May 6, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Chinese University of Hong Kong
• Contact: Angel Chim, MSc
• Phone: +852 3505 4205
• Email: angelchim[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3300
• Est. completion date: December 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients with positive hepatitis B surface antigen (HBsAg) for 6 months

• Under the care of GOPC

Exclusion Criteria:

• Age under 18

• Refusal to consent

Related Conditions & MeSH terms

• Chronic Hep B
• Hepatitis B
• Hepatitis B, Chronic

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkage-to-care	referral rate of patients from GOPC and SOPC who fulfil treatment criteria	3 years
Secondary	Unnecessary referral	referral rate of patients from GOPC and SOPC who do not fulfil treatment criteria	3 years
Secondary	GOPC care management rate	transient elastography uptake rate, fibrosis staging, clinical events, default rate	3 years
Secondary	SOPC care management rate	antiviral uptake care, fibrosis staging, clinical events, default rate	3 years

External Links

•   Building a Caring, Inclusive Society, Improving People's Livelihood
•   Combating hepatitis B and C to reach elimination by 2030
•   Hepatitis B
•   Hepatitis C
•   Surveillance of Viral Hepatitis in Hong Kong - 2016 Update Report