Conditions: Hepatitis B, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 671
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.

Detailed description:

Arms:
arm 1: PegIntron 1.0 mcg/kg weekly (QW) \* 24 weeks + 24 weeks follow-up arm 2: PegIntron 1.5 mcg/kg QW \* 24 wks + 24 wks follow-up arm 3: PegIntron 1.5 mcg/kg QW \* 48 wks + 24 wks follow-up

Interventions: intervention 1: pegylated interferon alpha-2b intervention 2: pegylated interferon alpha-2b intervention 3: pegylated interferon alpha-2b
Intervention descriptions: intervention 1: 1.0 mcg/kg subcutaneously (S.C.) QW for 24 weeks intervention 2: 1.5 mcg/kg S.C. QW for 24 weeks intervention 3: 1.5 mcg/kg S.C. QW for 48 weeks

Protocol document: