Viral Diseases
Conditions
Interventions
Two groups:Peginterferon Alfa-2a (40 KD) (PEGASYS?) 180 mcq per week for 48 weeks versus placebo
Sponsors
Roche Hong Kong Limited
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion: age 18-70; HBsAg positive for more than 6 months and detectable HBV DNA; previous use of nucleostide analogue for at least 12 months and the treatment has been stopped for at least 6 months; elevated serum ALT > 1.5X ULN but = 14 days apart during the 6 months before the first dose of study drug with at least one of the determinations obtained during the sreening period.
Exclusion criteria
Exclusion criteria: Exclusions: evidence of decompensated liver disease, HCC, pre-existing severe depression or other psyciatric disease, significant cardiac, significant renal disease, seizure disorder or severe retinopathy; positive test at screening for HIV or HCV; serum total bilirubin > 3X ULN at screening; neutrophil count 120umol/ml for men and > 105 umol/ml for women at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBeAg positive patients response is defined as HBeAg loss and presence of anti-HBe (HBeAg seroconversion).;HBeAg Negative patients response is defined as DNA<20,000 copies/ml and ALT normalization both measured at week 72.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with HBV DNA levels <100,000 copies/ml at week 72.;2. Percentage of patients with HBV DNA levels <10,000 copies/ml at week 72;3. Percentage of patients with HBV DNA levels negative by PCR at week 72.;4. ALT normalization at week 72.;5. HBsAg seroconversion at week 72.;6. Safety of treatment; | — |
Countries
China
Contacts
Public ContactDr Henry LY Chan
Outcome results
None listed