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 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 1:04 AM
NCT ID:
NCT00558493
Eligibility Criteria:
Inclusion Criteria:
* HBV DNA \> 2,000 copies/mL at screening
* Patients who have compensated liver disease (Child-Pugh score =\<6)
* Patients without LMV resistant mutation by RFMP assay
* Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy
* Patients who can submit the written consent and comply with the claims postulated of this clinical trial
Exclusion Criteria:
* Currently receiving antiviral except LMV or corticosteroid therapy
* Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months
* Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening
* Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
* Patients who is co-infected with HCV, HDV or HIV
* Serious concurrent medical conditions
* Prior organ transplantation
* Patient has creatinine clearance less than 60mL/min as estimated by the following formula:
\[(140-age in years) (body weight \[kg\])\] / \[(72) (serum creatinine\] \[mg/dL\])\[Note: multiply estimates by 0.85 for women\]
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00558493
Study Brief:
Protocol Section:
NCT00558493