Hepatitis B, Chronic
Conditions
Brief summary
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Interventions
DRUGpeginterferon alfa-2a (40KD) [PEGASYS]
180 micrograms sc weekly for 48 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* adult patients, 18-65 years of age; * HBeAg negative chronic hepatitis B; * treated with lamivudine for \>=6 months; * demonstrated lamivudine resistance; * compensated liver disease.
Exclusion criteria
* severe hepatic dysfunction; * previous treatment with antivirals other than lamivudine; * immunosuppressant treatment in past 6 months; * co-infection with hepatitis A, C, or D virus or human immunodeficiency virus; * medical condition associated with chronic liver disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Normalization of ALT, and HBV-DNA <10,000 copies/mL | Week 96 |
Secondary
| Measure | Time frame |
|---|---|
| Normalization of ALT, and HBV-DNA <10,000 copies/mL | Weeks 48 and 72 |
| HBsAg loss and anti-HBs seroconversion | Weeks 48, 72 and 96 |
| AEs and lab parameters | Throughout study |
Countries
Turkey (Türkiye)
Outcome results
None listed