NCT03329820

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. 1.Patients with chronic hepatitis B virus (HBV) have poorer health-related quality of life (HRQOL) than the general population;
  2. 2.Patients with more severe stages of chronic HB infections have lower health related quality of life and health utility values;
  3. 3.Anti-viral treatment can improve the HRQOL and health utility for patients with CHB infections;
  4. 4.The cost-effectiveness of different treatments for chronic HBV infections can be directly compared in terms of cost/QALY gained.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
589

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

2.6 years

First QC Date

October 24, 2017

Last Update Submit

October 30, 2017

Conditions

Chronic Hepatitis B Infection

Keywords

Chronic hepatitis B infectionHealth-related quality of lifeCost-effectivenessTreatmentChinese

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (3)

  • SF-6D Preference-based health utilities

    Baseline

  • Quality adjusted life years

    Baseline

  • Costs of different treatment strategies for HBV infection

    Baseline

Study Arms (5)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chinese adults with chroni hepatits B infection.

You may qualify if:

  • 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:
  • (i) Uncomplicated CHB: Patients with chronic CHB infections but normal liver function and without cirrhosis or HCC.
  • (ii) CHB with impaired liver function or compensated cirrhosis, not on anti-viral treatment.
  • (iii) CHB with impaired liver function or compensated cirrhosis, on anti-viral treatment.
  • (iv) Decompensated cirrhosis: Patients with CHB infection and cirrhosis complicated by one or more of the following: variceal bleeding, hepatic encephalopathy or ascites.
  • (v) Hepatocellular Carcinoma: Patients with confirmed diagnosis of HCC
  • d. Have given written consent to take part in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Two Regional Hospitals

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head and Clinical Professor

Study Record Dates

First Submitted

October 24, 2017

First Posted

November 6, 2017

Study Start

November 1, 2006

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

November 6, 2017

Record last verified: 2017-10

Locations

HK(1)