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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hepatitis B, Chronic
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 141
- Locations
- 9
- Primary Endpoint
- Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study
Time Frame: At the end of the study (Week 36)
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).
Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml
Time Frame: approximately 3 years
In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive
Time Frame: approximately 3 years
Secondary Outcomes
- 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)
- HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative(approximately 3 years)
- Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment(At the end of treatment (Week 24))
- Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients(approximately 3 years)