A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

Status:	Active, not recruiting
Conditions:	Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	3 - 17
Updated:	2/3/2019
Start Date:	July 11, 2012
End Date:	November 9, 2021

A Phase IIIb Parallel Group, Open Label Study of Pegylated Interferon Alfa-2a Monotherapy (PEG-IFN, Ro 25-8310) Compared to Untreated Control in Children With HBeAg Positive Chronic Hepatitis B

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.

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

- Negative anti-HBs and anti-HBe 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

We found this trial at

sites

St. Louis University - Cardinal Glennon Children's Medical Center

Saint Louis, Missouri 63104

from

Saint Louis, MO