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

Roche

Status: Terminated

Conditions: Hepatitis B, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01886300

ML27807

Details and patient eligibility

About

This prospective, multicenter, observational study will evaluate the sustained response in patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to standard of care and in line with the current local labeling in routine clinical practice in Vietnam. Eligible patients will be followed for the duration of their treatment and for up to 2 years thereafter.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• HBeAg-positive serologically proven chronic hepatitis B with or without cirrhosis
• Elevated serum ALT > ULN (upper limit of normal) but </= 10 x ULN
• Patients with no contra-indications to Pegasys therapy as detailed in the label
• Written informed consent where local regulations allow or require it

Exclusion criteria

• Patients should not receive concomitant therapy with telbivudine
• Co-infection with hepatitis A, hepatitis B or HIV
• Pregnant or breastfeeding women
• Patients with depression/mental diseases
• Neutrophil at baseline > 90.000/mm3
• Abnormal T4 or TSH

Trial design

16 participants in 1 patient group

Cohort