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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT01471535
Eligibility Criteria:
Inclusion Criteria:
* HBsAg positive and anti-HBs negative for more than 6 months
* HBeAg-negative/anti-HBe-positive
* Persistently undetectable HBV DNA with normal ALT levels, as established at 3-6 monthly intervals during the preceding 2 yrs
* Serum HBsAg levels ≤100 IU/mL, as determined on two occasions during the month prior to treatment
* Absence of previous antiviral therapy
Exclusion Criteria:
* With active alcohol and/or drugs consumption
* With human immunodeficiency virus or hepatitis C virus coinfections
* With clinical evidence of cirrhosis
* With history of autoimmune hepatitis
* With hematological or psychiatric diseases
* With evidence of neoplastic diseases
* With severe cardiac or pulmonary disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01471535
Study Brief:
Protocol Section:
NCT01471535