Conditions: Hepatitis B, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 131
Healthy volunteers: no

Brief summary:
This study will compare the efficacy and safety of 2 different durations of treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with Hepatitis B e Antigen (HBeAg)-negative chronic hepatitis B virus (HBV). It will also compare PEG-IFN alfa 2a treatment alone and in combination with lamivudine (LAM). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: Treatment with PEG-IFN in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. arm 2: Treatment with PEG-IFN in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN treatment (total 96 weeks of treatment). arm 3: Treatment with PEG-IFN and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN treatment (total 96 weeks of treatment).

Interventions: intervention 1: Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg intervention 2: Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg intervention 3: Lamivudine (LAM)
Intervention descriptions: intervention 1: PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48. intervention 2: PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96. intervention 3: Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48.

Protocol document: