Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
3–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
