An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B

Study Overview
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Brief Summary
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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.

Official Title
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A MULTICENTER, PROSPECTIVE, OBSERVATIONAL, NON-INTERVENTIONAL COHORT STUDY IN CHINESE SUBJECTS WITH HBeAg NEGATIVE CHRONIC HEPATITIS B (CHB) RECEIVING THERAPY WITH PEGINTERFERON ALFA

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Drug: Pegylated Interferon Alfa (Peginterferon Alfa)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Hepatitis B Participants<br>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. | Drug: Pegylated Interferon Alfa (Peginterferon Alfa)<br>* Peginterferon alfa dosing and treatment duration are at the discretion of the investigator in accordance with China clinical practice and local labeling.<br>* Other names: Pegasys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sustained suppression of HBV DNA <2000 IU/mL one year after treatment cessation |  | approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of suppression of HBV DNA <2000 IU/mL at the end of treatment and 6 months post-treatment |  | 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 | 
| Incidence of normalization of serum ALT levels |  | 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 |