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:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-24 @ 5:32 PM
NCT ID:
NCT00737568
Eligibility Criteria:
Inclusion Criteria
* Chronic HBV infection, defined as positive serum HBsAg for at least 6 months
* 18 through 75 years of age, inclusive
* HBV DNA ≥ 10\^3 IU/mL
* Receiving treatment with lamivudine with confirmation of HBV reverse transcriptase mutation(s) known to confer resistance to lamivudine (rtM204I/V with or without rtL180M) by central laboratory assessment prior to randomization; adefovir dipivoxil treatment of ≤ 48 weeks at the time of screening (inclusive of combination adefovir dipivoxil + lamivudine at entry) was allowed
* Willing and able to provide written informed consent
* Negative serum pregnancy test (for females of childbearing potential only)
* Calculated creatinine clearance ≥ 50 mL/min
* Hemoglobin ≥ 10 g/dL
* Neutrophils ≥ 1000 /mm\^3
* No prior oral HBV therapy with approved nucleotide and/or nucleoside therapy or other investigational agents for HBV infection other than lamivudine or adefovir dipivoxil
Exclusion Criteria
* Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study
* Males and females of reproductive potential who are not willing to use an effective method of contraception during the study
* Alanine aminotransferase (ALT) ≥ 10 × the upper limit of the normal range (ULN)
* Decompensated liver disease
* Interferon or pegylated interferon therapy within 6 months of the screening visit
* Alpha fetoprotein \> 50 ng/mL
* Evidence of hepatocellular carcinoma
* Coinfection with hepatitis C virus, HIV, or hepatitis D virus
* Significant renal, cardiovascular, pulmonary, or neurological disease
* Received solid organ or bone marrow transplantation
* Receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
* Proximal tubulopathy
* Known hypersensitivity to the study drugs, the metabolites or formulation excipients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00737568
Study Brief:
Protocol Section:
NCT00737568