Overview

This trial is active, not recruiting.

Condition hepatitis b, chronic
Treatments peginterferon alfa-2a [pegasys]
Phase phase 3
Sponsor Hoffmann-La Roche
Start date July 2012
End date August 2022
Trial size 165 participants
Trial identifier NCT01519960, 2011-002732-70, YV25718

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
peginterferon alfa-2a [pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48
(No Intervention)
(Experimental)
peginterferon alfa-2a [pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48
(Experimental)
peginterferon alfa-2a [pegasys]
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

Primary Outcomes

Measure
HBeAg seroconversion (loss of HBeAg and presence of anti-HBe) 24 weeks after end of treatment/principal observation period with a further 4.5 years of follow-up
time frame: 24 weeks post-treatment/principal observation period

Secondary Outcomes

Measure
HBsAg seroconversion (loss of HBsAg and presence of anti-HBs)
time frame: up to 8 years
Loss of HBeAg/HBsAg
time frame: up to 8 years
Serum alanine aminotransferase (ALT) levels
time frame: up to 8 years
Proportion of normal ALT
time frame: up to 8 years
HBV DNA levels
time frame: up to 8 years
Change in liver elasticity (elastography)
time frame: from baseline to Week 72
Group C: Change in histological findings (liver biopsy)
time frame: from baseline to Week 72
Pharmacokinetics: Area under the concentration-time curve (AUC)
time frame: Weeks 1 and 24, pre-dose and 24-48, 72-96 and 168 hours post-dose
Safety: Incidence of adverse events
time frame: up to 8 years
Safety: Growth
time frame: up to 8 years

Eligibility Criteria

Male or female participants from 3 years up to 17 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.