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Sequential therapy with tenofovir disoproxil fumarate and pegylated interferon alfa in immune tolerant children with chronic hepatitis B virus infection

Sequential therapy with tenofovir disoproxil fumarate and pegylated interferon alfa in immune tolerant children with chronic hepatitis B virus infection

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-14005752
Enrollment
Unknown
Registered
2014-12-07
Start date
2014-12-30
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 virus infection

Interventions

Case series:Sequential therapy with tenofovir disoproxil fumarate and pegylated interferon alfa

Sponsors

Department of Infectious Diseases, Nanfang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Male or female, 3 to 12 years of age; 2. detection of HBsAg and HBeAg in serum for longer than 6 months prior to baseline visit; 3. Serum HBV DNA levels more than 1.0E+07 IU/mL; 4. ALT less than 40IU/L; 5. Absolute neutrophil count more than 1.5 G/L and platelet count more than 120 G/L; 6. Creatinine clearance more than 80 mL/min; 7. Anti-HBV na?ve children.

Exclusion criteria

Exclusion criteria: 1. Presence of infection with HCV-RNA or anti-HCV, anti-HDV, or HIV at screening; 2. Evidence of active liver disease; 3. History of significant renal, cardiovascular, pulmonary, neurological, autoimmune or bone disease; 4. History of a seizure disorder or current anticonvulsant use; 5. History of thyroid disease poorly controlled on prescribed medications.

Design outcomes

Primary

MeasureTime frame
HBV DNA;HBeAg;HBsAg;

Secondary

MeasureTime frame
Liver function;

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