Status:
COMPLETED
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
Brief 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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 11 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 18 2021
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT01519960
Start Date
July 11 2012
End Date
October 18 2021
Last Update
November 18 2022
Active Locations (39)
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1
Univ of California SF, Benioff Children's Hospital; Pediatrics, Gastro, Hepatology & Nutrition
San Francisco, California, United States, 94143
2
Johns Hopkins Hospital - Pediatric Gastroenterology
Baltimore, Maryland, United States, 21287-5554
3
Children's Hospital Boston-Harvard Medical School; Division of Gastoenterology
Boston, Massachusetts, United States, 02115
4
St. Louis University - Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104