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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT00798460
Eligibility Criteria:
Inclusion Criteria:
* HBsAg positive and anti-HBs negative more than 6 months
* YMDD mutation (+)during lamivudine therapy
* Serum ALT more than two times upper normal value
Exclusion Criteria:
* HAV IgM Ab + and/or HCV Ab+ and/or HDV Ab and/or HIV Av+
* The sign of decompensated liver disease
* Pregnant or lactating woman
* The history of hemoglobinopathy, autoimmune hepatitis, alcoholic liver disease
* Hemoglobin less than 8 g/dL (male), 7.5g/dL (female) or neutrophil count less than 1500/mm3 or platelet count less than 50,000/mm3
* Serum creatinine more than 1.5 times upper normal limit value
* The sign of malignancy or suggestive of malignancy or the history of malignancy, the recurrence rate within 2 years of which is more than 20%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00798460
Study Brief:
Protocol Section:
NCT00798460