Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-25 @ 4:25 AM
NCT ID:
NCT03329820
Eligibility Criteria:
Inclusion Criteria:
Subjects will be included in the study if they:
1. Are 18 years and above in age;
2. Are known to be HBsAg positive for more than six months;
3. 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.
Exclusion Criteria:
Subjects will be excluded from the study if they have one of the following:
1. Unable to understand and communicate in Chinese Language;
2. Known cognitive impairment;
3. Diagnosed end-stage non-hepatitis B related chronic illness such as terminal cancer;
4. Patients currently abusing alcohol (\>30 units/week) or illegal drugs;
5. Co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV);
6. Post-liver transplant;
7. Refuse to give consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03329820
Study Brief:
Protocol Section:
NCT03329820