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 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT01667432
Eligibility Criteria:
Inclusion Criteria:
* Adult patients ≥ 18 years of age.
* Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis.
* Elevated alanine aminotransferase (ALT) \> upper limit of normal (ULN) but ≤ 10 x ULN according to local label.
Exclusion Criteria:
* Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label.
* Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).
* Concomitant treatment with telbivudine.
* Pregnant or lactating women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01667432
Study Brief:
Protocol Section:
NCT01667432