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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT01732367
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients aged 18 or older
* The CHB patients (both HBeAg-positive and - negative) who have at least 6 months undetectable HBV DNA (serum HBV DNA ≤ 20 IU/mL) after lamivudine plus adefovir combination therapy.
Exclusion Criteria:
* Patients with decompensated liver disease
* Patients with HCV, HDV or HIV
* Patients with HCC
* Serum ALT \> 2x ULN level
* Serum creatinine \> 2.0mg/dL
* Pregnant or lactating women
* Women who have a plan for pregnancy within the three coming years
* Patients who have uncontrolled severe concomitant diseases- severe cardiovascular diseases and other infection
* Those who have no capabilities to understand and sign an informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01732367
Study Brief:
Protocol Section:
NCT01732367