An Observational Study of Peginterferon Alfa-2a (PEGASYS®) in Patients With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

Roche

Status: Completed

Conditions: Hepatitis B, Chronic

Treatments: Biological: Peginterferon alfa-2a

Study type: Observational

Funder types: Industry

Identifiers

NCT01667432

ML25626

Details and patient eligibility

About

This prospective, multicenter, observational study will evaluate on-treatment predictors of response in patients with HBeAg positive or HBeAg negative chronic hepatitis B receiving treatment with peginterferon alfa-2a (PEGASYS®) in accordance with local labeling and the summary of product characteristics. Data will be collected from patients for the duration of their treatment and for up to 24 weeks thereafter.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients ≥ 18 years of age.
• Hepatitis B envelope antigen (HBeAg) positive or HBeAg negative hepatitis B with or without cirrhosis.
• Elevated alanine aminotransferase (ALT) > upper limit of normal (ULN) but ≤ 10 x ULN according to local label.

Exclusion criteria

• Contraindications to peginterferon alfa-2a (PEGASYS®) as detailed in the label.
• Co-infection with hepatitis A, hepatitis C, or human immunodeficiency virus (HIV).
• Concomitant treatment with telbivudine.
• Pregnant or lactating women.

Trial design

141 participants in 1 patient group

Peginterferon alfa-2a

Description:

Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.

Treatment:

Biological: Peginterferon alfa-2a