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 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT00371150
Eligibility Criteria:
Inclusion Criteria:
* Chronic HBV infection, with either HBeAg-positive (HBeAb-negative) or HBeAg-negative (HBeAb-positive) disease
* Black/African American Race and/or Hispanic ethnicity
* Nucleoside/tide-naive
* Males or females ≥ 16 years of age (or minimum age required in a given country)
* Compensated liver function
* ALT of 1.3 to 10 x upper limit of normal (ULN)
* No Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV)
Exclusion Criteria
* Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 6 weeks after study medication has been discontinued
* Women who are pregnant or breastfeeding
* Women with a positive pregnancy test on enrollment or prior to study drug administration
* Evidence of decompensated cirrhosis including but not limited to: variceal bleeding; hepatic encephalopathy; or ascites requiring management with diuretics or paracentesis
* Recent history of pancreatitis (resolution of any recent pancreatitis must be documented by normal lipase at least 12 weeks prior to the first dose of study medication)
* Currently abusing illegal drugs or alcohol sufficient, in the investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis
* Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications
* Serum creatinine \> 1.5 mg/dL
* Hemoglobin \< 10.0 g/dL
* Platelet count \< 70,000/mm3
* Absolute neutrophil count \< 1200 cells/mm3
* Serum alpha fetoprotein (AFP) level \> 100 ng/mL. If the AFP level is between 21 and 100 ng/mL, it must be repeated. If the repeat AFP level is between 21 and 100 ng/mL and if ultrasonography or computerized tomography (CT) of the liver performed prior to the first dose of study medication does not demonstrate a focal lesion suggestive of carcinoma, the subject may be dosed in the study
* Known history of allergy to nucleoside analogues
* Any prior therapy with Entecavir
* Any prior or concomitant use of nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., ETV, lamivudine (LVD), tenofovir \[TDF\], emtricitabine (FTC), clevudine, telbivudine \[LdT\], famciclovir), or any other experimental anti-HBV antiviral agent
* Therapy with interferon, thymosin alpha or other immunostimulators within 24 weeks of enrollment (i.e., dosing) into this study
* Subjects who require chronic administration of concomitant medications which cause immunosuppression or which are associated with a high rate of nephrotoxicity or hepatotoxicity, or which affect renal excretion, should not be enrolled in this study
* Unable to tolerate oral medication
* Poor peripheral venous access
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT00371150
Study Brief:
Protocol Section:
NCT00371150