Overview

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

Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
0
Participant gender:
All
Summary
This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys 180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during treatment and for 24 weeks of follow-up.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Interferon-alpha
Peginterferon alfa-2a
Criteria
Inclusion Criteria:

- Adult patients, >/= 18 and
- HBeAg-negative chronic hepatitis B

- HBsAg-positive for at least 6 months, anti- hepatitis B (HBs) negative

- Serum alanine transaminase (ALT) > 2 ULN (upper limit of normal) but limit of normal (ULN)

- Hepatitis B virus (HBV) DNA > 10'000 copies/ml (Roche Monitor or Taqman)

- No previous treatment with interferon (standard or pegylated) or with a nucleoside
analogue

- Women of childbearing potential must agree to use reliable contraception during the
study and for 3 months after treatment completion

Exclusion Criteria:

- Previous antiviral interferon-based therapy for chronic hepatitis B

- Pregnant and lactating women

- Evidence of decompensated liver disease

- Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human
immunodeficiency virus (HIV)

- History or other evidence of a medical condition associated with chronic liver disease
other than viral hepatitis

- Previous or current hepatocellular carcinoma

- History or other evidence of bleeding from oesophageal varices or other conditions
consistent with decompensated liver disease

- Inadequate hematologic or renal function

- Serum bilirubin level > 2 times the upper limit of normal

- Severe psychiatric disease

- History of severe seizure disorder or current anticonvulsant use

- History of evidence of any disease or condition which would make the patient, in the
opinion of the investigator, unsuitable for the study

- Evidence of drug abuse within one year of study entry

- Alcohol intake of more than 3 standard drinks per day for men and 2 standard drinks
per day for women (1 standard drink contains 10 g of alcohol)

- Participation in another trial or receipt of an investigational drug within 12 weeks
prior to screening