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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT03597633
Eligibility Criteria:
Inclusion Criteria:
* CHB patients with:
1. documented HBsAg positivity at least 6 months before enrollment
2. age \>18 years old,
3. confirmed genotypic resistance to more than two classes of NAs
4. HBV DNA level ≥ 200 IU/mL
5. compensated liver diseases (defined by Child-Pugh-Turcotte score \<7; prothrombin time \<3 seconds above upper limit of normal or international normalized ratio \<1.5; serum albumin \>3 g/dL; total bilirubin \<2.5 mg/dL; no history of esophago-gastric variceal bleeding, ascites, over hepatic encephalopathy)
6. willingness to give an informed consent.
Exclusion Criteria:
1. laboratory abnormalities of low serum phosphorous level \<2.0 mEq/dL, elevated serum creatinine \>1.5 mg/dL, decreased creatinine clearance rate \<50 mL/min, absolute neutrophil count \<1000 cell/mL, or low hemoglobin level \<10 g/dL (if female, \<9 g/dL)
2. no definite evidence of genotypic resistance
3. positive antibody test for hepatitis C virus, hepatitis D virus, or human immunodeficiency virus
4. HCC
5. a proof of pregnant or lactating women
6. evidence of active alcohol consumption (140 g per a week for men and 70 g per a week for women)
7. any untreated malignancy.
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03597633
Study Brief:
Protocol Section:
NCT03597633