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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT01711567
Eligibility Criteria:
Inclusion Criteria:
1. CHB patients (positive HBsAg more than 6 months)
2. Age 19 years old
3. HBeAg positive or negative patients
4. Patients receiving entecavir 0.5 mg more than 12 months
5. Detectable HBV DNA by real time PCR (HBV \> 60 IU/mL)
6. Compensated liver function (Child-Pugh-Turcotte score ≤7, prothrombin time 3 sec above ULN or INR ≤1.5, serum albumin \>3 g/dL, total bilirubin \<2.5 mg/dL, no history of variceal bleeding, diuretics or ascites requiring paracentesis, hepatic encephalopathy)
Exclusion Criteria:
1. History of treatment with nucleotide analogue other than 0.5 mg of ETV
2. Serum creatinine level \> 1.5 mg/dL or creatinine clearance \< 50 mL/min
3. Absolute neutrophil count ≤ 1000 cell/mL
4. Hemoglobin level ≤ 10 g/dL in men or ≤ 9 g/dL in women
5. Antiviral resistance mutations on rtT184, rtS202, or rtM250 + rtM204V/I
6. A positive antibody test for human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
7. Pregnancy or lactation
8. HCC (in cases where alfa-fetoprotein levels were over 100 ng/mL, abdominal computed tomography or magnetic resonance image was performed to exclude HCC)
9. Untreated malignancy other than HCC.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT01711567
Study Brief:
Protocol Section:
NCT01711567