Treatment Prioritisation and Cost-Effectiveness Analysis for HBV Cure - Real-World Evidence from a Territory-Wide Cohort

NCT ID: NCT06627608

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-06-30

Brief Summary

A number of hepatitis B virus (HBV) cure regimens including antisense oligonucleotide (ASO) and small interfering RNA (siRNA) are under vigorous clinical development and the efficacy and safety will soon be available for regulatory approval. Patients most in need should be prioritised to receive HBV cure regimen to maximise its clinical benefits and speed up hepatitis elimination.

Detailed Description

A territory-wide cohort study of all patients with chronic hepatitis B who have achieved functional cure of HBV. Real-world data will be used to estimate the risk of HCC, hepatic decompensation, and liver-related death for the subsequent simulation of HCC risk in particular populations of patients who achieved HBV cure. Literature search also be performed in parallel to cross-validate the estimates in untreated patients, and treated patients with incomplete or complete viral suppression with different stages of fibrosis based on existing literature. An optional systematic review and meta-analysis may be performed the address these issues.

Conditions

Chronic Hepatitis B

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

1. Patients with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart, AND

2. Patients achieved HBV cure, i.e. HBsAg turned negative

3. Aged 18 years old or above.

Exclusion Criteria

1. Patients with missing age and gender

2. Serious medical illnesses or malignancy with life expectancy <1 year

3. Age < 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Grace Lai Hung Wong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Angel Chim, MSc

Role: CONTACT

angelchim@cuhk.edu.hk

4076686013

Grace Wong, MD

Role: CONTACT

wonglaihung@cuhk.edu.hk

4076686013

Other Identifiers

CEA for HBV cure

Identifier Type: -

Identifier Source: org_study_id