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

Roche

Status and phase: Completed; Phase 3

Conditions: Hepatitis B, Chronic

Treatments: Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519960

2011-002732-70 (EudraCT Number)

YV25718

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 4 patient groups

A Pegasys

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

B Untreated Control

No Intervention group

C Fibrosis non-randomized

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Switch

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]