Phase 4
N=150
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Positive Chronic Hepatitis B.
Hepatitis B, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01519921 ↗Enrolled (actual)
150
Serious AEs
6.0%
Results posted
Jan 2016
Primary outcome: Primary: Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72 — 20.9; 21.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- peginterferon alfa-2a [Pegasys] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Hepatitis B Virus DNA <100,000 Copies/mL At Week 72 |
20.9; 21.9 | — |
| PRIMARY Percentage of Participants With Hepatitis B Virus e Antigen Loss At Week 72 |
20.9; 23.4 | — |
| SECONDARY Percentage of Participants With ALT Normalization At Week 48 and Week 72 |
34.9; 29.7; 36.0; 29.7 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus DNA Below the Limit of Detection At Week 48 and Week 72 |
10.5; 10.9; 3.5; 9.4 | — |
| SECONDARY Percentage of Participants With a Combined Response At Week 48 and Week 72 |
8.1; 9.4; 9.3; 14.1 | — |
| SECONDARY Percentage of Participants With Hepatitis B Virus e Antigen Seroconversion |
15.1; 23.4; 20.9; 21.9 | — |
| SECONDARY Percentage of Participants With Loss of Hepatitis B Surface Antigen At Week 48 and Week 72 |
1.2; 1.6; 1.2; 1.6 | — |
| SECONDARY Percentage of Participants With Hepatitis B Surface Antigen Seroconversion At Week 48 and Week 72 |
1.2; 0.0; 1.2; 1.6 | — |
| SECONDARY Number of Participants With Any Adverse Events and Any Serious Adverse Events |
75; 54; 4; 5 | — |
Summary
This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.
Eligibility Criteria
Inclusion Criteria
- Adult patients, 18-65 years of age
- HBsAg +ve for more than 6 months, HBeAg +ve, AntiHBs -ve
- Detectable hepatitis B virus (HBV) DNA (>100,000 copies/mL)
Exclusion Criteria
- Coinfection with hepatitis A, hepatitis C or human immunodeficiency virus (HIV)
- Evidence of decompensated liver disease
- A medical condition associated with chronic liver disease other than viral hepatitis
Data sourced from ClinicalTrials.gov (NCT01519921). 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.