A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA
Overview
- Phase
- Not Applicable
- Intervention
- Pegylated Interferon Alfa (Peginterferon Alfa)
- Conditions
- Hepatitis B, Chronic
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 978
- Locations
- 88
- Primary Endpoint
- Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local label will be followed for the duration of their treatment and for one year after cessation of treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult participants, \>/= 18 years of age
- •Treatment with Pegasys according to label and standard clinical practice
- •HBeAg negative serologically proven chronic hepatitis B with or without cirrhosis
- •Serum alanine aminotransferase (ALT) \> upper limit of normal (ULN) but \</= 10 x ULN
- •Hepatitis B Virus (HBV) DNA \>/= 2000 IU/mL
Exclusion Criteria
- •Contraindications to Pegasys as detailed in the label
- •Co-infection with hepatitis A, hepatitis C or HIV
- •Pregnant or lactating women
- •Participants should not receive concomitant therapy with telbivudine
Arms & Interventions
Chronic Hepatitis B Participants
Hepatitis B e antigen (HBeAg) chronic hepatitis B (CHB) participants who received treatment with pegylated interferon alfa (peginterferon alfa) according to China labeling and China standard of care and were followed up to 1 year after treatment cessation.
Intervention: Pegylated Interferon Alfa (Peginterferon Alfa)
Outcomes
Primary Outcomes
Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation
Time Frame: approximately 4 years
Secondary Outcomes
- Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment(approximately 4 years)
- Incidence of normalization of serum ALT levels(approximately 4 years)
- Incidence of HBV DNA undetectable (<400 IU/mL) at the end of treatment and 1 year post-treatment(approximately 4 years)
- Incidence of HBsAg loss/seroconversion(approximately 4 years)
- Dosage/schedule of Pegasys treatment in real-life clinical setting(approximately 4 years)
- Clinical/demographic patient characteristics at initiation of treatment(approximately 4 years)
- Safety: Incidence of adverse events(approximately 4 years)