An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: Peginterferon alfa-2a [Pegasys]
Intervention description: 180 mcg subcutaneously weekly, 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 and </= 70 years of age

          -  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 </= 10 x Upper
             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