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 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT01595633
Eligibility Criteria:
Inclusion Criteria:
* subjects with age \>= 20 years
* subjects with chronic hepatitis B
* subjects treated with nucleoside analogues plus adefovir for at least 6 months due to resistance to nucleoside analogues (Lamivudine, Telbivudine, Entecavir, or Clevudine)
* subjects with partial virologic response to nucleoside analogues plus adefovir HBV DNA ≥ 60 IU/mL)
* subjects with ALT less than 5 times of upper limit of normal
* subjects who agreed to participate in the clinical trials and signed the informed consents
Exclusion Criteria:
* subjects with decompensate liver cirrhosis Child-Pugh B, C)
* subjects with Adefovir mutation
* subjects with HCV, HDV, or HIV infection
* pregnant or lactating women
* women of childbearing age who do not use the appropriate contraception method
* subjects who have the abnormal lesion suspected of hepatocellular carcinoma on imaging modalities
* subjects with other liver diseases such as hemochromatosis, Wilson's disease, alcoholic liver disease, nonalcoholic liver disease, alpha-1 antitrypsin deficiency
* subjects with hypersensitivity for study drugs
* subjects who participated in other clinical trials 60 days before the current recruitment
* subjects who are judged as inappropriate by investigators
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT01595633
Study Brief:
Protocol Section:
NCT01595633