An Observational Study of Pegasys (Peginterferon Alfa-2a) in Chinese Patients With HBeAg Negative Chronic Hepatitis B

Roche

Status: Completed

Conditions: Hepatitis B, Chronic

Treatments: Drug: Pegylated Interferon Alfa (Peginterferon Alfa)

Study type: Observational

Funder types: Industry

Identifiers

NCT01730508

ML28516

Details and patient eligibility

About

This multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of Pegasys (peginterferon alfa-2a) in Chinese participants with HBeAg negative chronic hepatitis B. Participants receiving Pegasys according to the local label will be followed for the duration of their treatment and for one year after cessation of treatment.

Enrollment: 978 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult participants, >/= 18 years of age
• Treatment with Pegasys according to label and standard clinical practice
• HBeAg negative serologically proven chronic hepatitis B with or without cirrhosis
• Serum alanine aminotransferase (ALT) > upper limit of normal (ULN) but </= 10 x ULN
• Hepatitis B Virus (HBV) DNA >/= 2000 IU/mL

Exclusion criteria

• Contraindications to Pegasys as detailed in the label
• Co-infection with hepatitis A, hepatitis C or HIV
• Pregnant or lactating women
• Participants should not receive concomitant therapy with telbivudine

Trial design

978 participants in 1 patient group

Chronic Hepatitis B Participants

Description:

Hepatitis B e antigen (HBeAg) chronic hepatitis B (CHB) participants who received treatment with pegylated interferon alfa (peginterferon alfa) according to China labeling and China standard of care and were followed up to 1 year after treatment cessation.

Treatment:

Drug: Pegylated Interferon Alfa (Peginterferon Alfa)