A Study on Antiviral Treatment of Chronic Hepatitis B in Children
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
Summary
There are nearly 2 million HBsAg-positive children who are in urgent need of professional
diagnosis and treatment in China. Chronic hepatitis B (CHB) is the leading cause of childhood
liver disease. After infected with HBV virus, some children will develop disease progression,
and some even develop cirrhosis and/or liver cancer. In pediatric liver cancer cases, up to
34% ~ 95% are caused by HBV infection.
Although two major classes of drugs have been approved for the treatment of chronic hepatitis
B in adults, and there are multiple guidelines worldwide for the management of HBV infection
in adults, there is lack of guidelines specifically for the management of children with HBV
infection. In addition, the treatment of chronic hepatitis B in children faced great
difficulties due to the lack of evidence-based medical evidence for antiviral treatment of
chronic hepatitis B in children and fewer drugs approved for anti-HBV treatment in children.
The timing of treatment, medications, and clinical management strategies are all
controversial.
This study ( Sprout project)，is a multicenter, prospective, cohort study in China, aiming to
explore and optimize the antiviral treatment regimen for children with HBV infection, to
provide evidence-based medical for antiviral treatment, and to provide basis evidence for the
standardized management of children infection with HBV in China. The study is expected to
enroll 1900 pediatric patients with HBV infection, and patient will received one of the three
following treatment Strategies: nucleoside monotherapy, peginterferon α- combined with
nucleoside therapy, or peginterferon α-pulse therapy combined with nucleoside therapy,
according to their illness state and desire, and the safety and efficacy will be evaluated.