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pegylated Interferon treatment with enticavir-experienced hepatitis B e antigen-positive chronic hepatitis B priotity patients.:a prospective, open, controlled multi-center study

pegylated Interferon treatment with enticavir-experienced hepatitis B e antigen-positive chronic hepatitis B priotity patients.:a prospective, open, controlled multi-center study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012055
Enrollment
Unknown
Registered
2017-07-20
Start date
2017-09-30
Completion date
Unknown
Last updated
2017-07-24

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

Conditions

Chronic hepatitis B

Interventions

1:entacavir
2:pegylated Interferon adding entecavir
3:pegylated Interferon adding entecavir

Sponsors

Shanghai Public Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 50 years; 2. HBsAg lasts for more than 6 months; 3. The duration of the entecavir exceeds 2 years; 4. The value of HBeAg exceed 200S/co at the start of the treatment; 5. At the screening, HBeAg is postive,the load of HBVDNA is undetected, the value of HBs; Ag is less than 3000IU/ml,and the value of HBeAg is less than 200S/co.

Exclusion criteria

Exclusion criteria: 1. HAV or HCV or HDV or HEV or HIV is postive; 2. The value of AFP exceed 100 ng/ml; 3. The value of Fibroscan exceed 10Kpa or the result of ultrasound is cirrhosis; 4. The value of ANC is less than 1.5×109 or the value of PLT is less than 90×10^9; 5. The history of alcoholic abuse in 1 year; 6. Depression; 7. Severe immunue disease; 8. Severe heart, lung, renal, brain and hematopathy disease; 9. The value of creatinine is above 1.5ULN; 10. Uncontrolled diabetes, hypertension, thyroid diseases; 11. Severe retina disease.

Design outcomes

Primary

MeasureTime frame
HBeAg seroconvention rate;

Countries

China

Contacts

Public ContactHuang yuxian

Shanghai Public Clinical Center

yxhuang@fudan.edu.cn+86 18121150751

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026