A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Intervention: peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]
Intervention description: Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48; Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, after Week 48 for Group B patients who have not experienced HBeAg seroconversion
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This parallel group, open label study will evaluate the safety and efficacy of Pegasys
      (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at
      baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and
      without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg
      subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with
      advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment
      with Pegasys. Children in the untreated control Group B who have not experienced
      seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of
      Pegasys treatment. This offer will be available for 1 year following 48 weeks from
      randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed
      up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients, 3 years to <18 years of age at baseline

          -  Positive HBsAg for more than 6 months

          -  Positive HBeAg and detectable HBV DNA at screening

          -  A liver biopsy obtained within the past 2 years prior to baseline (and more than 6
             months after the end of previous therapy for hepatitis B) to confirm the presence of
             advanced fibrosis or exclude cirrhosis

          -  Compensated liver disease (Child-Pugh Class A)

          -  Elevated serum alanine transferase (ALT)

          -  Normal thyroid gland function at screening

        Exclusion Criteria:

          -  Subjects with cirrhosis

          -  Subjects must not have received investigational drugs or licensed treatments with
             anti-HBV activity within 6 months of baseline. Subjects who are expected to need
             systemic antiviral therapy other than that provided by the study at any time during
             their participation in the study are also excluded

          -  Known hypersensitivity to peginterferon

          -  Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV
             infection

          -  History or evidence of medical condition associated with chronic liver disease other
             than chronic hepatitis B

          -  History or evidence of bleeding from esophageal varices

          -  Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C)

          -  History of immunologically mediated disease

          -  Pregnant or lactating females