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

NCT04904900 | Unknown DMC

• 1 other identifier: HBV_GOPC study
• Study Type: observational
• Target: 3,300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hep B

Outcome Measures

Primary Outcomes (1)

• Linkage-to-care

  referral rate of patients from GOPC and SOPC who fulfil treatment criteria

  3 years

Secondary Outcomes (3)

• Unnecessary referral

  3 years

• GOPC care management rate

  3 years

• SOPC care management rate

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

300 prospectively from FM/GOPC 3000 retrospectively from CDARS.

You may qualify if:

• Adult patients with positive hepatitis B surface antigen (HBsAg) for 6 months
• Under the care of GOPC

You may not qualify if:

• Age under 18
• Refusal to consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Related 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.

  PMID: 26563120 BACKGROUND

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for * Liver function test (including albumin, bilirubin, ALT) * Alpha-fetoprotein * Hepatitis B surface antigen (HBsAg), Hepatitis B e antigen (HBeAg) and antibody to Hepatitis B e antigen (anti-HBe) * HBV DNA

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grace LH Wong, Prof

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angel Chim, MSc

CONTACT

+852 3505 4205; angelchim@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 27, 2021
• Study Start: May 6, 2021
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

HK (1)