A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: PEG-Intron™; PEGASYS™
Intervention description: PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks; PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 402.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is being done to compare the safety and efficacy of PEG-Intron™ to that of
      PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen [HBeAg]
      positive or negative) who have not previously been treated with interferon.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be able to adhere to dose and visit schedules

          -  ≥ 40 kg

          -  Hepatitis B surface antigen (HBsAg) positive for at least 6 months

          -  Anti-HBs negative

          -  Female participants of childbearing potential must agree to use an acceptable

        method of contraception from at least 2 weeks prior to Day 1 and continue until at least 1
        month after last dose of study drug

        Inclusion Criteria for HBeAg(+) participants:

          -  HBeAg(+)

          -  Anti-HBe(-)

        Inclusion Criteria for HBeAg(-) participants:

          -  HBeAg(-)

          -  Anti-HBe(+)

        Exclusion Criteria:

          -  Co-infection with the human immunodeficiency virus (HIV) or hepatitis C or hepatitis D
             virus

          -  Prior treatment with interferon for hepatitis B

          -  Use of nucleoside/nucleotide analogues within 6 months of the screening visit or at
             any time during the study

          -  Use of any investigational drug within 30 days of the screening visit

          -  Prior treatment with herbal remedies with known hepatotoxicity. All herbal remedies
             used for hepatitis B treatment must be discontinued before Day 1

          -  Evidence of decompensated liver disease including, but not limited to, a history or
             presence of clinical ascites, bleeding varices, or hepatic encephalopathy

          -  Diabetic and/or hypertensive with clinically significant ocular examination findings

          -  History of stroke or transient ischemic attack

          -  Immunologically mediated disease (e.g., inflammatory bowel disease [Crohn's disease,
             ulcerative colitis], celiac disease, rheumatoid arthritis, idiopathic thrombocytopenic
             purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma,
             sarcoidosis, severe psoriasis requiring oral or injected treatment, or symptomatic
             thyroid disorder)

          -  Chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, interstitial
             lung disease, pulmonary fibrosis, sarcoidosis)

          -  Current or history of any clinically significant cardiac abnormalities/dysfunction

          -  Any medical condition requiring, or likely to require, chronic systemic administration
             of corticosteroids during the course of the trial

          -  Myelodysplastic syndromes

          -  Organ transplants (including hematopoietic stem cell transplants) other than cornea
             and hair

          -  Pregnant or nursing, or intending to become pregnant during the trial period