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 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
NCT ID:
NCT01531166
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects receiving treatment for CHB with PEGASYS according to standard of care and in line with the current summary of product characteristics(SPC)/ local labeling who have no contra-indication to PEGASYS therapy as per the local label.
* Adult chronic hepatitis B patients (20 years of age or older) who has been completed or are currently receiving or are planned to receive Pegasys® as a first-line therapy.
* Those with baseline HBV DNA \> 2,000 IU/mL and elevation of ALT level.
* HBeAg positive or HBeAg negative serologically proven chronic hepatitis B(CHB)
* Subjects treated with previous NAs therapy are eligible for this study.
Exclusion Criteria:
Subjects with ALT \> 10 x ULN or evidence of hepatocellular carcinoma.
* Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
* Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.
* Subjects should have no other diseases that might be contraindication to peg-interferon therapy as per local SPC (e.g., severe psychiatric diseases, immunological diseases, severe retinopathy or thyroid dysfunction, history of severe pre-existing cardiac disease, etc)
* Subjects with other contra-indications to PEGASYS therapy as detailed in the label (hypersensitivity to the active substance, to alpha interferons, or to any of the excipients)
* A history of liver transplantation or planned for liver transplantation
* Subjects who receive concomitant therapy with telbivudine.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01531166
Study Brief:
Protocol Section:
NCT01531166