An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

Study Overview
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Brief Summary
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This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.

Official Title
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A Multicenter, Prospective, Observational, Non-interventional Study Evaluating On-treatment Predictors of Response in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B Receiving Therapy With PEGASYS® (Peginterferon Alfa-2a 40KD)

Conditions
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Hepatitis B, Chronic

Intervention / Treatment
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* Biological: Peginterferon alfa-2a


Participation Criteria
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Eligibility Criteria
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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.

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 |
| --- | --- |
| Peginterferon alfa-2a<br>Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks. | Biological: Peginterferon alfa-2a<br>* Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.<br>* Other names: RO0258310;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study | Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml). | At the end of the study (Week 36) | 
| Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml |  | approximately 3 years | 
| In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive |  | approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment | Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) was assessed in plasma samples using quantitative polymerase chain reaction (PCR). Results are reported in international units (IU) per milliliter (ml) separately for participants who were hepatitis B envelope antigen (HBeAg) positive and HBeAg negative. | At the end of treatment (Week 24) | 
| HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative |  | approximately 3 years | 
| Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients |  | approximately 3 years | 
| Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients |  | approximately 3 years | 
| Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio |  | approximately 3 years | 
| Safety: Incidence of Adverse Events |  | approximately 3 years |