NCT05792761

A Study on Antiviral Treatment of Chronic Hepatitis B in Children

A Study on Antiviral Treatment of Chronic Hepatitis B in Children (Sprout Project)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,900 (estimated)
• Sponsor: Fang Wang · Academic / Other
• Sex: All
• Age: 3 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic HBV Infection

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2b combined and ETV	Child patients are assigned to one of the 3 treatment regimens according to their illness state and treatment desire of their parents/guardians, and the number of patients in each group is expected to limited to 300. 1. NA monotherapy group : received entecavir (ETV) for 96 weeks. 2. Combination therapy group: received peginterferon alfa-2b combined with ETV for 96 weeks. 3. Pulse therapy group :received peginterferon alfa-2b pulse treatment combined with ETV for 144 weeks.

Timeline

• Start date: 2021-05-06
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2023-03-31
• Last updated: 2023-03-31

Locations

1 site across 1 country: China