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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT01597934
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 20 years of age
2. History of HBsAg positive for more than 6 months
3. History of genotypic resistance to LAM or LdT (YMDDm)
4. Partial responder (HBV DNA ≥ 60 IU/mL) currently receiving antiviral combination rescue therapy for at least 24 weeks of treatment with LAM+ADV or LdT+ADV
5. Hepatitis B e Antigen(HBeAg)-positive and -negative
6. Compensated liver disease (Child-Pugh A)
7. Signed written informed consent after being instructed about the objective and procedure of the clinical study
Exclusion Criteria:
1. History of genotypic resistance to ADV
2. Most previous treatment of other than LAM+ADV and LdT+ADV
3. Subjects with Alanine Aminotransferase(ALT) \> 10xUpper Limit of normal(ULN)
4. Co-infected with hepatitis C virus(HCV) or HIV
5. Pregnant or lactating woman
6. Subject who needs long-term administration of drugs including immunosuppressive agents, agents related to high risk in the hepatic/renal toxicity, agents influencing renal excretion
7. History of liver transplantation or planned for liver transplantation
8. Subject who was diagnosed malignant tumor and has been receiving chemotherapy
9. Subject who has HCC history or who shows potential hepatocellular carcinoma (HCC) finding such as suspicious region in the radiologic exam(abdominal US or CT) or serum Alpha Feto Protein(AFP) elevation
10. Renal Insufficiency (CLcr \< 50ml/min based on Cockcroft-Gault equation considering weight, ages and serum creatinine)
11. Subject who has a liver disease other than chronic hepatitis B (e.g. hemochromatosis, Wilson's disease, alcoholic liver disease, nonalcoholic fatty liver disease, alpha 1-antitrypsin deficiency etc.)
12. Subject who has a history of hypersensitivity to study drug or its ingredients
13. Subject who is involved in other clinical trial within 60 days prior to study entry
14. Subject who the investigator deems inappropriate to participate in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01597934
Study Brief:
Protocol Section:
NCT01597934