Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-25 @ 4:57 PM
Study NCT ID:
NCT03329820
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2017-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life and Health Utility of Patients With CHB Infections
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Quality of Life and Health Utility of Patients With Chronic Hepatitis B Infections
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to assess the health-related quality of life (HRQOL) and preference-based health utilities of chronic hepatitis B (CHB) carriers in different stages of illness. It will also estimate the cost-effectiveness of anti-viral treatments resulting from the prevention of the progression of disease from uncomplicated CHB carriers to cirrhosis and hepatocellular carcinoma (HCC).
The following hypotheses will be tested:
1. Patients with chronic hepatitis B virus (HBV) have poorer health-related quality of life (HRQOL) than the general population;
2. Patients with more severe stages of chronic HB infections have lower health related quality of life and health utility values;
3. Anti-viral treatment can improve the HRQOL and health utility for patients with CHB infections;
4. The cost-effectiveness of different treatments for chronic HBV infections can be directly compared in terms of cost/QALY gained.
The following hypotheses will be tested:
1. Patients with chronic hepatitis B virus (HBV) have poorer health-related quality of life (HRQOL) than the general population;
2. Patients with more severe stages of chronic HB infections have lower health related quality of life and health utility values;
3. Anti-viral treatment can improve the HRQOL and health utility for patients with CHB infections;
4. The cost-effectiveness of different treatments for chronic HBV infections can be directly compared in terms of cost/QALY gained.
Detailed Description:
Design, Setting \& Subjects: A cross-sectional study and biomathematical modelling will be carried out. In the cross-sectional study, patients known to CHB carriers will be identified from the registries of the Ap Lei Chau, Aberdeen and Sai Yung Pun General Outpatient Clinics and Queen Mary Hospital. The biomathematical modelling will use a simulated cohort of patients aged 18 or above with CHB infections who may receive treatment in Hong Kong. Published data on the benefit of anti-viral treatments and the cross-sectional study data on preference-based health utility values of different stages of CHB infections will be used to estimate the cost-effectiveness of different treatment strategies using Markov modelling.
Interventions: Each subject in the cross-sectional study will be interviewed. Five strategies for management of CHB infections: 1) No treatment, 2) Interferon monotherapy, 3) lamivudine monotherapy, 4) adefovir and 5) combined treatment of lamivudine and adefovir, will be tested in the biomathematical modelling,.
Main Outcome Measures: Health-related quality of life measured by the SF-36, preference-based health utilities measured by the SF-6D. quality adjusted life years (QALYs) and cost of different treatment strategies for HBV infection.
Hypothesis: HRQOL and health utilities of patients with different illness stages, and the QALYs gained and cost-effectiveness of different therapeutic strategies will be established. The results will provide information on the health burden of CHB infections, and evidence on the cost-effectiveness of anti-viral treatments in preventing disease progression can be directly compared.
Interventions: Each subject in the cross-sectional study will be interviewed. Five strategies for management of CHB infections: 1) No treatment, 2) Interferon monotherapy, 3) lamivudine monotherapy, 4) adefovir and 5) combined treatment of lamivudine and adefovir, will be tested in the biomathematical modelling,.
Main Outcome Measures: Health-related quality of life measured by the SF-36, preference-based health utilities measured by the SF-6D. quality adjusted life years (QALYs) and cost of different treatment strategies for HBV infection.
Hypothesis: HRQOL and health utilities of patients with different illness stages, and the QALYs gained and cost-effectiveness of different therapeutic strategies will be established. The results will provide information on the health burden of CHB infections, and evidence on the cost-effectiveness of anti-viral treatments in preventing disease progression can be directly compared.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: