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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT00531167
Eligibility Criteria:
Inclusion Criteria:
1. Chronic hepatitis B patients (positive HBsAg \> 6 months)
2. Age \> 16 year old
3. Serum alanine aminotransferase (ALT) \>1.5 x ULN
4. History of treatment with lamivudine more than 6 months
5. Proven lamivudine resistant mutation
6. HBV DNA level\> 20000 IU/mL
7. Compensated liver disease (Child-Pugh-Turcotte score over 7; prothrombin time prolonged more than 3 sec above ULN or INR over 1.5; serum albumin \>3 g/dL; total bilirubin \<2.5 mg/dL; No history of variceal bleeding, ascites, or hepatic encephalopathy)
8. Patients willing to give informed consent
Exclusion Criteria:
1. Out of inclusion criteria
2. Any one of following
* Serum phosphorus level under 2.4 mg/dL
* Serum creatinine level over 1.5 mg/dL or creatinine clearance \<50 mL/min
* Absolute neutrophil count lower than 1000 cell/mL
* Hb level under 10 g/dL (male), under 9 g/dL (female)
* Serum AFP \>100 ng/mL
3. History of treatment with interferon-a, thymosin-alfa 1, or nucleos(t)ide analogue other than lamivudine in 6 months of screening
4. Recipient of organ transplantation
5. Positive antibody test to HIV, HCV or HDV
6. Pregnant or breast feeding women
7. Patients with hepatocellular carcinoma or uncontrolled malignant disease
8. Habitual alcohol drinker (\>140 g/week for men, \>70 g/week for women)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
75 Years
Study:
NCT00531167
Study Brief:
Protocol Section:
NCT00531167