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:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2025-12-24 @ 5:57 PM
NCT ID:
NCT00513968
Eligibility Criteria:
Inclusion Criteria:
* Chronic hepatitis B infected patient documented with positive HBsAg for 3 months and more at screening
* Chronic hepatitis B infected patient with positive HBeAg at screening
* Patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry
* HBV DNA more than 1x10\^5 copies/mL through COBAS Amplicor HBV monitor assay or bDNA method at screening
* Patient with HBV DNA decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir
* Patient with ALT value between ULN x 1.5 and ULN x 5 at screening
* Patient given a written consent voluntarily
Exclusion Criteria:
* Have uncompensated liver disease
* Serum creatinine \> ULN x 1.5
* Are positive for Hepatitis C, hepatitis D or HIV infection (confirmed by ELISA assay)
* Had a previous liver or bone marrow transplant
* Are currently taking any immunosuppressant or any possible immune modulatory drugs
* Women who are pregnant or breastfeeding
* Woman or man who plans a birth for study duration
* Any experience of severe adverse drug reaction or any medical history of severe allergic disease
* Patient with any severe disease (for example, heart failure, renal failure, pancreatitis, diabetes mellitus) affecting the study in discretion of investigator except liver disease
* Patient with any other liver disease but hepatitis B (for example, hemochromatosis, Wilson's disease, alcoholic/non-alcoholic liver diseae)
* Patient with intrahepatic tumors confirmed by imaging (liver biopsy)and abnormally increased alpha-fetoprotein
* Patient with any present malignant tumor except liver or its history
* Other inappropriate patient in discretion of investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00513968
Study Brief:
Protocol Section:
NCT00513968