In this open-label multicenter study the long-term effect of Pegasys monotherapy on pharmacodynamic HBV-related markers will be investigated in patients with chronic hepatitis B. Eligible patients will have completed treatment on another donor protocol (e.g. PP22512) and will receive Pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. Target sample size is \<100.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 48 weeks
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Grafton, New Zealand
Unnamed facility
Singapore, Singapore
Unnamed facility
The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA
Time frame: assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up
Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications
Time frame: assessed every 2 months on treatment and up to week 24 of follow-up
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Singapore, Singapore
Unnamed facility
Taipei, Taiwan