Viral Diseases
Conditions
Interventions
Two groups:PEG-Intron A 100mcq sc once weekly, Lamivudine 100mg QD treatment period 104 weeks (include 32 doses of PEG-Intron A and 96 or 104 weeks Lamivudine) versus one year treatment of Lamivudine
Sponsors
Schering-Plough
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion: 18 - 65 years of age; documented serum HBsAg positive for at least 6 months prior to screening; evidnece of HBV replicatioin documented by serum HBV DNA > 10^6 copies per me at screening; serum HBeAg positive at screening; presence of abnormal ALT (1.3-10XULN) at screening; WBC >= 4,000/mm^3; platelets >= 100,000/mm^3; bilirubin normal (except for Gilbert's disease); albumin stable and normal.
Exclusion criteria
Exclusion criteria: Exclusion: co-infection with hepatitis C virus and/ or HIV; evidence or history of decompensated liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. End-of-treatment complete response-normalization of ALT and negative HBV DNA at the end of treatment.;2. Viral response - negative HBV DNA at the end of treatment and 26 weeks after cessation of treatment.;3. Biochemical response - normalization of ALT at the end of treatment and 26 weeks after the cessaion of treatment.;4. Safety of treatment; | — |
Contacts
Public ContactDr Henry LY Chan
Outcome results
None listed