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

Roche

Status: Completed

Conditions: Hepatitis B, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01734018

ML25614

Details and patient eligibility

About

This multicenter, prospective, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or without cirrhosis
• Elevated serum ALT > ULN (upper limit of normal) but </=10 x ULN according to local label

Exclusion criteria

• Contra-indications to Pegasys as detailed in the label
• Co-infection with hepatitis A, hepatitis B or HIV
• Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label)
• Pregnant or breastfeeding women

Trial design

50 participants in 1 patient group

Cohort