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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT01083251
Eligibility Criteria:
Inclusion Criteria:
* patients were eligible if they had been HBsAg positive for at least 6 months,
* patients were HBeAg positive or negative,
* patients had increased serum ALT levels between 1 and 10 times the upper limit of normal (ULN),
* patients had serum HBV-DNA levels greater than 1.0 x 10E5 copies/mL (2.0 X 10E4 IUmL), and
* patients had findings on a liver biopsy within the preceding 12 months that were consistent with the presence of chronic hepatitis B.
Exclusion Criteria:
* decompensated liver disease,
* antiviral therapy within 6 months before randomization,
* viral co-infections (hepatitis C virus, hepatitis delta virus, or human immunodeficiency virus), or
* pre-existent neutropenia or thrombocytopenia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01083251
Study Brief:
Protocol Section:
NCT01083251