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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2a

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) treatmentthe 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