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Extended Pegylated Interferon alfa-2a (40KD) Therapy in Chinese Patients with HBeAg-Negative Chronic Hepatitis B: A Single-center, Prospective, Randomized Open-labelled Study

Efficacy and Safety of extended duration of Peginterferon alfa-2a (40KD) on HBeAg Negative Chronic Hepatitis B Patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002970
Enrollment
Unknown
Registered
2012-07-30
Start date
2008-06-10
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

HBeAg Negative Chronic Hepatitis B Patients

Interventions

standard therapy group:pegylated interferon alfaa-2a
extended therapy group:pegylated interferon alfaa-2a

Sponsors

Guangdong General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. patients with HBeAg negative chronic hepatitis B from 18 to 65 years old; 2. patients with antivirus therapy first time; 3. Incluslon criteria were treatment-naive HBeAg-negative CHB with ALT>=2*ULN and 2000IU/mL<=HBV DNA<=200000IU/mL.

Exclusion criteria

Exclusion criteria: 1. patients with known hypersensitivity to alpha interferons, to E. coli-derived products, to polyethyleneglycol or to any component of the product; 2. patients with autoimmune disease; 3. patients with decompensated cirrhosis; 4. HIV-HCV patients with cirrhosis and a Child-Pugh score>5; 5. patients with HAV, HCV, HDV and/or HIV; 6. pregnant woman; 7. patients with baseline neutrophil counts <1500 cells/mm3, with baseline platelet count <90,000/mm3 or baseline hemoglobin <12 g/dL; 8. Patients with psychiatric illness; 9. Patients with retinopathy including retinal hemorrhages, cotton wool spots, papilledema, optic neuropathy, and retinal artery or vein obstruction; 10. patients with endocrine disease.

Design outcomes

Primary

MeasureTime frame
HBsAg suppression rate;

Countries

China

Contacts

Public ContactChen Xiaoping
xiaopchen2003@yahoo.com.cn+86 18925100882

Outcome results

None listed

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