Conditions: Hepatitis B
Keywords: hepatitis B hepatitis B Virus (HBV) chronic hepatitis B telbivudine peginterferon
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 159
Healthy volunteers: no

Brief summary:
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.

Detailed description:

Arms:
arm 1: Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peginterferon alpha-2a (PEG-INF)180 μg subcutaneous injection once a week for 52 weeks. arm 2: Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks. arm 3: Peginterferon alpha-2a (PEG- INF) monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.

Interventions: intervention 1: Telbivudine (LdT) intervention 2: peginterferon alpha-2a
Intervention descriptions: intervention 1: 600 mg orally once daily for 104 weeks. intervention 2: 180 μg subcutaneous injection once a week for 52 weeks.

Protocol document: