Chronic Hepatitis B
Conditions
Keywords
HBeAg-positive, chronic, Hepatitis B, lamivudine, seroconversion, Chronic Hepatitis B
Brief summary
This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.
Interventions
DRUGLamivudine plus Polyethylene glyco-interferon alfa-2b
DRUGLamivudine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening. * Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.
Exclusion criteria
* Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with HBeAg seroconversion to anti-HBe | — |
Secondary
| Measure | Time frame |
|---|---|
| Normalization of alanine aminotransferase (ALT) | — |
| Undetectable HBV DNA | — |
| Histologic improvement | — |
| Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment | — |
Countries
Hong Kong
Outcome results
None listed