Hepatitis B, Chronic
Conditions
Brief summary
This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
DRUGPeginterferon alfa-2a
Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once 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 participants between 18 to 65 years of age * HBeAg-positive chronic HBV * Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.
Exclusion criteria
* Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment * Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV) * Evidence of decompensated liver disease * Medical condition associated with chronic liver disease other than viral hepatitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL) | 72 weeks |
| Percentage of participants with HBeAg seroconversion | 72 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs | Weeks 48 and 72 |
| Number of participants with alanine aminotransferase (ALT) normalization | Weeks 48 and 72 |
| Number of participants who achieved HBV DNA levels below limit of detection | Weeks 48 and 72 |
| Incidence of adverse events | up to 72 weeks |
| Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization) | Weeks 48 and 72 |
| Number of participants with HBsAg loss | Weeks 48 and 72 |
Countries
China
Outcome results
None listed