A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Entecavir in Treatment-Naive Patients With HBeAg-Positive Chronic Hepatitis B.
Phase 4
Completed
- Conditions
- Hepatitis B, Chronic
- Interventions
- Drug: peginterferon alfa-2a [Pegasys]
- Registration Number
- NCT00614471
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 3 arm study will assess the efficacy and safety of PEGASYS + entecavir combination therapy in treatment-naive patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms s.c./week for 48 weeks, 2)PEGASYS 180 micrograms s.c./week for 48 weeks + entecavir 0.5mg p.o. once daily from week 13 to week 36 or 3) entecavir 0.5mg p.o. once daily for 24 weeks + PEGASYS 180 micrograms s.c./week from week 21 to 68. Treatment will be followed by 24 weeks treatment-free follow up. The anticipated time on study treatment is 3-12 months for groups 1 and 2, and 1-2 years for group 3, and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 219
Inclusion Criteria
- adult patients, 18-65 years of age;
- HBsAg positive, HBeAg positive and anti-HBe negative for at least 6 months, anti-HBs negative;
- absence of cirrhosis confirmed by liver biopsy in previous 12 months.
Exclusion Criteria
- previous treatment for chronic hepatitis B within previous 6 months;
- antiviral, anti-neoplastic or immunomodulatory treatment in previous 6 months;
- co-infection with active hepatitis A, hepatitis C, hepatitis D or HIV;
- history or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 peginterferon alfa-2a [Pegasys] - 3 Entecavir - 3 peginterferon alfa-2a [Pegasys] - 2 peginterferon alfa-2a [Pegasys] - 2 Entecavir -
- Primary Outcome Measures
Name Time Method Log change in quantitative HBeAg from baseline to 24 weeks after end of treatment. Week 72 for Arms 1 and 2. Week 92 for Arm 3.
- Secondary Outcome Measures
Name Time Method AEs, laboratory parameters. Throughout study HBeAg seroconversion, HBV-DNA <1000 copies/mL, loss of HBeAg, HBV DNA reduction, ALT normalization, loss of HBsAg seroconversion, reduction of HBsAg 24 weeks after end of treatment. Week 72 for Arms 1 and 2. Week 92 for Arm 3.