Chronic Hepatitis B InfectionNCT03329820
Quality of Life and Health Utility of Patients With CHB Infections
An observational study of Chronic Hepatitis B Infection, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B Infection
- How many people
- 589 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2006to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chinese adults with chroni hepatits B infection.
Who may be able to join
- Subjects will be included in the study if they:
- Are 18 years and above in age;
- Are known to be HBsAg positive for more than six months;
- Can be classified into one of the following sages of liver diseases:
- Uncomplicated CHB: Patients with chronic CHB infections but normal liver function and without cirrhosis or HCC.
- CHB with impaired liver function or compensated cirrhosis, not on anti-viral treatment.
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- CHB with impaired liver function or compensated cirrhosis, on anti-viral treatment.
- Decompensated cirrhosis: Patients with CHB infection and cirrhosis complicated by one or more of the following: variceal bleeding, hepatic encephalopathy or ascites.
- Hepatocellular Carcinoma: Patients with confirmed diagnosis of HCC
- Have given written consent to take part in the study.
Who cannot join
- Subjects will be excluded from the study if they have one of the following:
- Unable to understand and communicate in Chinese Language;
- Known cognitive impairment;
- Diagnosed end-stage non-hepatitis B related chronic illness such as terminal cancer;
- Patients currently abusing alcohol (>30 units/week) or illegal drugs;
- Co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV);
- Post-liver transplant;
- Refuse to give consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life and Health Utility of Patients With Chronic Hepatitis B Infections
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:
- Patients with chronic hepatitis B virus (HBV) have poorer health-related quality of life (HRQOL) than the general population;
- Patients with more severe stages of chronic HB infections have lower health related quality of life and health utility values;
- Anti-viral treatment can improve the HRQOL and health utility for patients with CHB infections;
- The cost-effectiveness of different treatments for chronic HBV infections can be directly compared in terms of cost/QALY gained.
Read the 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.
- Conditions
- Chronic Hepatitis B Infection
- Keywords
- Chronic hepatitis B infection, Health-related quality of life, Cost-effectiveness, Treatment, Chinese
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 Uncomplicated CHB | Patients with chronic CHB infections but normal liver function and without cirrhosis or hepatocellular carcinoma | |
| 2 CHB with impaired liver function (LF) or CC w/o tx | CHB with impaired liver function or compensated cirrhosis, not on anti-viral treatment | |
| 3 CHB with impaired LF or CC with tx | CHB with impaired liver function or compensated cirrhosis, on anti-viral treatment. | |
| 4 Decompensated cirrhosis | Patients with CHB infection and cirrhosis complicated by one or more of the following: variceal bleeding, hepatic encephalopathy or ascites. | |
| 5 Hepatocellular carcinoma | Patients with confirmed diagnosis of hepatocellular carcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 Health-related quality of life scores
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
Measured: Baseline
Secondary outcomes (3)
SF-6D Preference-based health utilities
The Short Form-6 Dimension (SF-6D) is a widely used preference-based generic HRQOL measure with a multiattribute classification system consisting of six dimensions: physical functioning, role functioning, social functioning, pain, mental health, and vitality. Each dimension is composed of three to five levels. The SF-6D values range from 0.315 to 1, with higher scores indicating better HRQOL anchoring on the 0 (dead) to 1 (full health) scale.
Measured: Baseline
Quality adjusted life years
To calculate QALYs under different anti-viral treatments that prevent progressions to cirrhosis and HCC, the life expectancy of a person with or without cirrhosis or HCC will be estimated, starting with the age of 18.
Measured: Baseline
Costs of different treatment strategies for HBV infection
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study startNov 2006
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B InfectionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Professor Cindy L.K. Lam, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329820
- Sponsor's protocol ID
- HKCTR-151
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Health Utility of Patients With Chronic Hepatitis B Infections
- ClinicalTrials.gov ID
- NCT03329820
- Acronym / sponsor ID
- HKCTR-151
- Conditions
- Chronic Hepatitis B Infection
- Keywords
- Chronic hepatitis B infection, Health-related quality of life, Cost-effectiveness, Treatment, Chinese
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- Nov 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patients with chronic hepatitis B virus (HBV) have poorer health-related quality of life (HRQOL) than the general population;
- Patients with more severe stages of chronic HB infections have lower health related quality of life and health utility values;
- Anti-viral treatment can improve the HRQOL and health utility for patients with CHB infections;
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 Uncomplicated CHB | – | –Patients with chronic CHB infections but normal liver function and without cirrhosis or hepatocellular carcinoma |
| 2 CHB with impaired liver function (LF) or CC w/o tx | – | –CHB with impaired liver function or compensated cirrhosis, not on anti-viral treatment |
| 3 CHB with impaired LF or CC with tx | – | –CHB with impaired liver function or compensated cirrhosis, on anti-viral treatment. |
| 4 Decompensated cirrhosis | – | –Patients with CHB infection and cirrhosis complicated by one or more of the following: variceal bleeding, hepatic encephalopathy or ascites. |
| 5 Hepatocellular carcinoma | – | –Patients with confirmed diagnosis of hepatocellular carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chinese adults with chroni hepatits B infection.
Key inclusion criteria (10 listed)
- Are 18 years and above in age;
- Are known to be HBsAg positive for more than six months;
- Can be classified into one of the following sages of liver diseases:
- Uncomplicated CHB: Patients with chronic CHB infections but normal liver function and without cirrhosis or HCC.
- CHB with impaired liver function or compensated cirrhosis, not on anti-viral treatment.
Key exclusion criteria (8 listed)
- Unable to understand and communicate in Chinese Language;
- Known cognitive impairment;
- Diagnosed end-stage non-hepatitis B related chronic illness such as terminal cancer;
- Patients currently abusing alcohol (>30 units/week) or illegal drugs;
- Co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SF-36 Health-related quality of life scores
Time frame: Baseline
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
3 secondary outcomes
SF-6D Preference-based health utilities
Time frame: Baseline
Quality adjusted life years
Time frame: Baseline
Costs of different treatment strategies for HBV infection
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B Infection, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 Health-related quality of life scores (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.