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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT00371761
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female, 18 to 70 years of age.
* Documented positive serum hepatitis B surface antigen (HBsAg) for a minimum of 6 months prior to randomization.
* Hepatitis B virus (HBV) replication and hepatitis documented by:
* Serum HBV DNA (Hepatitis B Virus Deoxyribonucleic acid) \>= 10\^5 copies/mL within 3 months prior to entry
* Positive serum hepatitis B e antigen (HBeAg) within 3 months prior to entry
* Documented presence of ALT (Alanine Aminotransferase) twice (1 month apart) within 3 months prior to entry (2 to 10 folds above the upper normal level)
* Liver biopsy finding shows evidence of chronic hepatitis without liver cirrhosis, document acceptable if no anti-HBV treatment within 1 year prior to randomization
* Naïve or exposed to lamivudine (3 months treatment-free interval prior to randomization)
* Adequate renal function (creatinine within normal upper limit).
* Compensated liver disease with certain minimum hematological and serum biochemical criteria.
* Thyroid stimulating hormone (TSH) and free T4 within normal ranges.
* Negative antibody to hepatitis C and hepatitis D.
* Negative antibody to human immunodeficiency virus.
* Negative evidence for hepatocellular carcinoma by alfa-fetoprotein and ultrasound within 1 month prior to randomization.
Exclusion Criteria:
* Women who are pregnant or nursing.
* Prior treatment for hepatitis with any interferon or adefovir, or other investigational anti-virus agents.
* Prior treatment for hepatitis with immunomodulatory drug within 2 years prior to randomization.
* Suspected hypersensitivity to interferon or adefovir.
* Liver cirrhosis.
* History of severe psychiatric disease, especially depression.
* Concurrent malignancies (including hepatocellular carcinoma).
* Unstable or significant cardiovascular diseases.
* Prolonged exposure to known hepatotoxins.
* History of thyroid disease poorly controlled on prescribed medication.
* Poorly controlled diabetes mellitus.
* Have suspected or confirmed significant hepatic disease from an etiology other than HBV.
* Severe renal disease or myeloid dysfunction.
* History of organ transplantation other than cornea and hair transplant.
* Any medical condition requiring chronic systemic administration of steroids.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00371761
Study Brief:
Protocol Section:
NCT00371761