Hepatitis B, Chronic
Conditions
Brief summary
This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a \[PEGASYS\] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is \>2 years.
Interventions
DRUGAdefovir
Adefovir 10 mg po once daily for 36 weeks
DRUGpeginterferon alfa-2a [PEGASYS]
Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
Sponsors
Major Science and Technology Special Project of China Eleventh Five-year
Hoffmann-La Roche
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
* Adult patients \>/=18 years of age * HBeAg positive chronic hepatitis B * Compensated liver disease
Exclusion criteria
* Patients who had previously received treatment of drugs with activity against HBV within 6 months prior to study start * Antiviral, anti-neoplastic or immunomodulatory treatment * Co-infection with active hepatitis A, hepatitis C, hepatitis D, or HIV * Evidence of decompensated liver disease * Chronic liver disease other than viral hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Quantitative HBsAG reduction (proportion of patients with HBsAG reduction) | Weeks 72, 96, 120 |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving HBeAG seroconversion and HBV DNA </=100000 copies/ml | Weeks 24, 48, 72, 96, 120 |
| Safety: Adverse Events | From baseline to Week 120 |
Countries
China
Outcome results
None listed