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International Multi-Center RWS Study of Antiviral Treatment in Pediatric Patients (1-12 Years Old) with IT Stage

International Multi-Center RWS Study of Antiviral Treatment in Pediatric Patients (1-12 Years Old) with IT Stage

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083200
Enrollment
Unknown
Registered
2024-04-18
Start date
2024-04-21
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Interventions

NAs monotherapy group:None
NAs combined with IFNa treatment group:None
Control group:None

Sponsors

Beijing You'an Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1 Age >1 year and 1×10^4 IU/mL. 3 HBeAg positive. 4 HBV DNA >2×10^7 IU/mL. 5 ALT <40 U/L (confirmed by two consecutive tests with a 3-6 month interval), or liver histology suggesting inflammation and fibrosis grade <1 (G<1 and S<1). 6 No antiviral treatment for at least 6 months prior to the study. 7 Obtained informed consent from legal guardians (both parents).

Exclusion criteria

Exclusion criteria: 1 Co-infection with HAV, HCV, HDV, HEV, HIV, EBV, CMV, or other viral infections. 2 Clinical diagnosis of cirrhosis. 3 Definitive diagnosis of liver cancer by imaging or histology. 4 Children undergoing interferon therapy must exclude contraindications to interferon treatment. 5 Other conditions deemed unsuitable for participation in this study by the investigators.

Design outcomes

Primary

MeasureTime frame
HBsAg;Hepatitis B core antibody;HBcrAg;pgRNA;

Secondary

MeasureTime frame
HBV DNA;HBeAg;Liver stiffness measurement;Abdominal ultrasound;

Countries

China

Contacts

Public ContactRen Shan

Beijing You'an Hospital, Capital Medical University

13811361553@163.com+86 138 1136 1553

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026