A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
- Registration Number
- NCT02604823
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 307
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group A (Naïve Participants) Peginterferon alfa-2a Participants who never received any HBV treatment, will receive peginterferon alfa-2a (180 micrograms \[mcg\]) subcutaneously once weekly for 48 weeks. Group B (Conventional Interferon Pretreated Participants) Peginterferon alfa-2a Participants who received conventional interferon treatment and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks. Group C (Lamivudine Pretreated Participants) Peginterferon alfa-2a Participants who received lamivudine and had relapse or did not respond, will receive peginterferon alfa-2a (180 mcg) subcutaneously once weekly for 48 weeks.
- Primary Outcome Measures
Name Time Method Percentage of participants with HBeAg seroconversion 72 weeks Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL) 72 weeks
- Secondary Outcome Measures
Name Time Method Number of participants who achieved HBV DNA levels below limit of detection Weeks 48 and 72 Number of participants with HBsAg loss Weeks 48 and 72 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 with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization) Weeks 48 and 72 Incidence of adverse events up to 72 weeks