Hepatitis B, Chronic
Conditions
Brief summary
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.
Interventions
DRUGpeginterferon alfa-2a [Pegasys]
dosage at discretion of investigator based on standard of care (180mcg sc weekly) for up to 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 No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients \>/=18 years of age * previous participation in other donor protocol * chronic hepatitis B * no other anti-HBV treatment after completion of previous donor protocol * female patients and female partners of male patients must use at least two methods of contraception until 28 days after completion of study
Exclusion criteria
* hepatic decompensation (Child-Pugh class B and C) * antiviral, antineoplastic or immunomodulatory treatment * evidence of alcohol and/or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The longitudinal effect on HBV-related markers: viral load, viral antigen/antibody, viral sequence, cellular and humoral immune responses, RNA | assessed every 2 months on treatment (not exceeding maximum approved duration), and up to week 24 of follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability: AEs, laboratory parameters, vital signs, concomitant medications | assessed every 2 months on treatment and up to week 24 of follow-up |
Countries
New Zealand, Singapore, Taiwan, United States
Outcome results
None listed