A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
Summary
This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Timeline
- Start
- 2010-05-07
- Primary completion
- 2014-09-29
- Completion
- 2014-09-29
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Peg-IFN-Alfa-2a + Adefovir vs Peg-IFN-Alfa-2a + Entecavir; p = 0.6853 NCT00922207 ↗
registry analysis (superiority or other test); Peg-IFN-Alfa-2a + Adefovir vs Peg-IFN-Alfa-2a + Placebo; p = 0.1977 NCT00922207 ↗
registry analysis (superiority or other test); Peg-IFN-Alfa-2a + Entecavir vs Peg-IFN-Alfa-2a + Placebo; p = 0.2916 NCT00922207 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adefovir | Unknown | — | — |
| Subject | Entecavir | Small molecule | — | — |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |