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

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: peginterferon alfa-2a [Pegasys] (Drug); peginterferon alfa-2a [Pegasys] (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

HBsAg seroconversion (loss of HBsAg and presence of anti-HBs)

Loss of HBeAg/HBsAg

Serum alanine aminotransferase (ALT) levels

Proportion of normal ALT

HBV DNA levels

Change in liver elasticity (elastography)

Group C: Change in histological findings (liver biopsy)

Pharmacokinetics: Area under the concentration-time curve (AUC)

Safety: Incidence of adverse events

Safety: Growth

Eligibility

Minimum age: 3 Years. Maximum age: 17 Years. Gender(s): Both.

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

- 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

Locations and Contacts

Brussels 1200, Belgium

Gent 9000, Belgium

Sofia 1612, Bulgaria

Varna 9000, Bulgaria

Beijing 100039, China

Beijing 100054, China

Changchun 130021, China

Chongqing 400038, China

Guangzhou 510060, China

Guangzhou 510630, China

Kunming 650032, China

Shanghai 200235, China

Urumqi 830000, China

Wuhan 430030, China

Xi'an 710061, China

Wuppertal 42283, Germany

Haifa 31096, Israel

Jerusalem 9112001, Israel

Nahariya 22100, Israel

Bydgoszcz 85-030, Poland

Krakow 31-202, Poland

Poznan 60-693, Poland

Łodz 91-347, Poland

Arkhangelsk 163045, Russian Federation

Moscow 119991, Russian Federation

Moscow 115446, Russian Federation

Saint Petersburg 197022, Russian Federation

Samara 443100, Russian Federation

Kyiv 01119, Ukraine

Kyiv 04050, Ukraine

Birmingham B4 6NH, United Kingdom

London SE5 9RS, United Kingdom

London W2 1PG, United Kingdom

San Francisco, California 94143, United States

Bologna, Emilia-Romagna 40138, Italy

Baltimore, Maryland 21287-5554, United States

Boston, Massachusetts 02115, United States

St. Louis, Missouri 63104, United States

Sydney, New South Wales 2145, Australia

Torino, Piemonte 10126, Italy

North Adelaide, South Australia 5006, Australia

Houston, Texas 77030, United States

Melbourne, Victoria 3053, Australia

Seattle, Washington 98105, United States

Additional Information

Starting date: July 2012
Last updated: August 17, 2015

Page last updated: August 23, 2015

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