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

Completed · Phase 3

Conditions studied: Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT01519960

Run by

Hoffmann-La Roche

People needed

165

Starts

2012-07-11

Expected to finish

2021-10-18

Last updated by the study team

2022-11-18

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Univ of California SF, Benioff Children's Hospital; Pediatrics, Gastro, Hepatology & Nutrition — San Francisco, California, United States
• Johns Hopkins Hospital - Pediatric Gastroenterology — Baltimore, Maryland, United States
• Children's Hospital Boston-Harvard Medical School; Division of Gastoenterology — Boston, Massachusetts, United States
• St. Louis University - Cardinal Glennon Children's Medical Center — St Louis, Missouri, United States
• Texas Children's Hospital — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Womens and Childrens Hospital; Department of Gastroenterology — North Adelaide, South Australia, Australia
• Royal Children's Hospital; Department of Gastroenterology — Melbourne, Victoria, Australia
• Cliniques Universitaires St-Luc — Brussels, Belgium
• UZ Gent — Ghent, Belgium
• Specialized Hospital for Active Treatment of Pediatrics Diseases; Clinic of Gastroenterology — Sofia, Bulgaria
• University Hospital "St. Marine"; Dept. of Pediatrics — Varna, Bulgaria
• Beijing 302 Hospital; No. 2 Infectious Disease Section — Beijing, China
• Beijing You An Hospital; Digestive Dept — Beijing, China
• the First Hospital of Jilin University — Changchun, China
• Southwest Hospital , Third Military Medical University — Chongqing, China
• The Eighth People's Hospital of Guangzhou — Guangzhou, China
• The Third Affiliated Hospital of Sun Yat-Sen University — Guangzhou, China
• The First Affilliated Hospital of Kunming Medical College — Kunming, China
• Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine — Urumqi (乌鲁木齐), China
• Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech — Wuhan, China
• First Affiliated Hospital of Medical College of Xi'an Jiaotong University — Xi'an, China
• HELIOS Klinikum Wuppertal, Zentrum für Kinder- und Jugendmedizin, Universität Witten-Herdecke — Wuppertal, Germany
• Rambam Medical Center — Haifa, Israel
• Hadassah University Hospital - Ein Kerem — Jerusalem, Israel

Full record on ClinicalTrials.gov

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