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Efficacy andsafety of Peginterferon alpha-2a in children with chronic hepatitis B

Efficacy andsafety of Peginterferon alpha-2a in children with chronic hepatitis B

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-15006238
Enrollment
Unknown
Registered
2014-10-01
Start date
2014-10-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Chronic hepatitis B

Interventions

Case series:Peginterferon alpha-2a

Sponsors

Department of Infectious Diseases, Nanfang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Male or female patients, 1 years to 12 years of age at baseline; 2.Positive HBsAg andHBeAg for more than 6 months; 3.Serum HBV DNA levels >1.0E+05copies/ml at screening; 4.Elevated serum ALT between 2 ULN and10 ULN for two times, andat least one month intervel.

Exclusion criteria

Exclusion criteria: 1.received antiviral therapy or immunosuppressant drugs within 6 months prior to enrollment; 2.Evidence of decompensated liver disease; 3.Presence of infection with HCV-RNA or anti-HCV, anti-HDV, or HIV at screening; 4.History of medical condition associated with chronic liver disease other than chronic hepatitis B; 5.History of significant renal, cardiovascular, pulmonary, neurological, autoimmune or bone disease; 6.History of a seizure disorder or current anticonvulsant use; 7.History of thyroid disease poorly controlled on prescribed medications.

Design outcomes

Primary

MeasureTime frame
Liver function;HBV DNA;HBeAg;HBsAg;

Countries

China

Contacts

Public ContactKangxian Luo
luokangxian31@163.com+86 13672457690

Outcome results

None listed

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