A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Pegylated Interferon (Peginterferon) Alfa-2a; Nucleos(t)ide Analogues (NA)
Intervention description: Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.; Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.
Intervention MeSH terms: Interferons
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, 18 - 65 years of age

          -  Chronic hepatitis B

          -  Negative for HBeAg

          -  On monotherapy with any nucleos(t)ide analogue (NA) but telbivudine at enrolment, and
             HBV DNA persistently below 20 IU/ml for at least 12 months

          -  HBsAg >100 IU/ml at the beginning of the Lead-in phase, confirmed before addition of
             Pegasys

          -  Showing a steady HBsAg kinetic (HBsAg decrease <0.5 log10 IU/ml from Week -12 to start
             of the Add-on phase)

          -  Negative pregnancy test for women of childbearing potential

          -  Women of childbearing potential and fertile males with female partners of childbearing
             potential must be using reliable contraception during and for 3 months after the
             Add-on phase

        Exclusion Criteria:

          -  Coinfection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus
             (HDV), Human Immunodeficiency virus (HIV)

          -  Evidence of decompensated liver disease (Child-Pugh >/=6)

          -  History or other evidence of a medical condition associated with chronic liver disease
             (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)

          -  Known hypersensitivity to peginterferon alfa-2a

          -  Pregnant of breastfeeding women

          -  Evidence of alcohol and/or drug abuse

          -  History of severe psychiatric disease, especially depression

          -  History of immunologically mediated disease

          -  History or evidence of bleeding from esophageal varices or other conditions consistent
             with decompensated liver disease

          -  History or evidence of severe pulmonary disease associated with functional limitations

          -  History of severe cardiac disease

          -  History of severe seizure disorder or current anticonvulsant use

          -  Evidence of an active or suspected cancer or a history of malignancy (other than
             basocellular carcinoma or in situ cervical carcinoma) within 5 years prior to study
             entry

          -  History of having received any systemic anti-neoplastic (including radiation) or
             immunomodulatory (including systemic corticosteroids) treatment </= 6 months prior to
             the first dose or the expectation that such a treatment will be needed at any time
             during the study

          -  History or other evidence of severe retinopathy