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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
180 micrograms sc weekly for 48 weeks
Unnamed facility
Ankara, Turkey (Türkiye)
Unnamed facility
Antalya, Turkey (Türkiye)
Unnamed facility
Istanbul, Turkey (Türkiye)
Unnamed facility
Izmir, Turkey (Türkiye)
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Time frame: Week 96
Normalization of ALT, and HBV-DNA <10,000 copies/mL
Time frame: Weeks 48 and 72
HBsAg loss and anti-HBs seroconversion
Time frame: Weeks 48, 72 and 96
AEs and lab parameters
Time frame: Throughout study
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