Conditions: Hepatitis B, Chronic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 76
Healthy volunteers: no

Brief summary:
This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg decline \<0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the participants will continue their NA treatment.

Detailed description:

Arms:
arm 1: Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than \<0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.

Interventions: intervention 1: Pegylated Interferon (Peginterferon) Alfa-2a intervention 2: Nucleos(t)ide Analogues (NA)
Intervention descriptions: intervention 1: Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks. intervention 2: Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.

Protocol document: