N/A
N=141
An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B
Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01667432 ↗Enrolled (actual)
141
Serious AEs
0.7%
Results posted
Dec 2015
Primary outcome: Primary: Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study — 38.8 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Peginterferon alfa-2a (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Suppression of HBV DNA to < 2,000 IU/ml at the End of the Study |
38.8 | — |
| PRIMARY Percentage of Patients With Suppression of HBV DNA < 2,000 IU/ml |
— | — |
| PRIMARY In HBeAg Positive Patients: Percentage of Patients Who Become HBeAg Negative and Anti-HBe Positive |
— | — |
| SECONDARY Percentage of Participants With Suppression of HBV DNA to < 80 IU/ml at the End of Treatment |
36.4; 26.6 | — |
| SECONDARY HBsAg Clearance: Percentage of Patients Who Become HBsAg Negative |
— | — |
| SECONDARY Correlation of HBsAg Clearance With Other On-treatment Factors in HBeAg Positive and HBeAg Negative Patients |
— | — |
| SECONDARY Correlation of HBsAg Clearance With Pre-treatment Factors in HBeAg Positive and HBeAg Negative Patients |
— | — |
| SECONDARY Incidence of Serum ALT Normalization: Serum ALT/ALT Ratio |
— | — |
| SECONDARY Safety: Incidence of Adverse Events |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01667432). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.