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

NCT06627608 | Not Yet Recruiting

• 1 other identifier: CEA for HBV cure
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Hepatitis B

Keywords

Cost-Effectiveness Analysis; HBV Cure

Outcome Measures

Primary Outcomes (1)

• Incidence rates of a composite endpoint of hepatic events, including hepatocellular carcinoma (HCC), cirrhotic complications and liver-related death

  This would be the first step to get the estimated incidence rates of these clinical events to facilitate to subsequent modelling of the impact of different estimated rates of HBV cure on the overall incidence of liver outcomes.

  20 years

Secondary Outcomes (4)

• Economic burden

  20 years

• Partial HBV cure

  20 years

• Establish the most desirable cost range

  20 years

• Healthcare resources saving

  20 years

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• 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
• Patients achieved HBV cure, i.e. HBsAg turned negative
• Aged 18 years old or above.

You may not qualify if:

• Patients with missing age and gender
• Serious medical illnesses or malignancy with life expectancy \<1 year
• Age \< 18 years

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

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

Central Study Contacts

Angel Chim, MSc

CONTACT

4076686013; angelchim@cuhk.edu.hk

Grace Wong, MD

CONTACT

4076686013; wonglaihung@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share