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:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT01794234
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/= 18 years of age
* Positive HBsAg for more than 6 months before assignment to treatment with Pegasys
* Detectable HBV DNA (as measured by PCR)
* HBeAg positive and negative patients
* Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard
* Elevated serum alanine aminotransferase (ALT)
* Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation
Exclusion Criteria:
* Contraindications to treatment with Pegasys according to the Summary of Product Characteristics
* Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
* Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment
* Planned other than Pegasys antiviral treatment during Pegasys therapy
* Chronic liver disease other than chronic hepatitis B
* Pregnant or breast-feeding women
* Inadequate hematologic function
* Autoimmunology disorders
* Co-infection with chronic hepatitis C or HIV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01794234
Study Brief:
Protocol Section:
NCT01794234