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An open clinical study for Peginterferon in HBeAg-negtive patients with chronic hepatitis B virus infection and low levels of HBsAg

An open clinical study for Peginterferon in HBeAg-negtive patients with chronic hepatitis B virus infection and low levels of HBsAg

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027154
Enrollment
Unknown
Registered
2019-11-02
Start date
2019-11-20
Completion date
Unknown
Last updated
2019-11-04

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

Treatment group:peginterferon monotherapy
Control group:do not receive antiviral therapy

Sponsors

The Second Affiliated Hospital of Xi’an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18 years to 65 years; 2) Serum HBsAg positive for over 6 months; 3) Quantitative HBsAg <= 3000 IU/mL,HBeAg negative, HBV DNA < 2.0x10^3 IU/mL, 4) Normal alanine aminotransferase (ALT) concentration 5) White blood counts (WBC) in a range of 4-10x10^9/L, platelet counts (PLT) in a range of 100-300 x 10^9/L; 6) Patients signed informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients had hepatitis A virus, hepatitis C virus, hepatitis D virus or human immunodeficiency virus (HIV) co-infection; 2) Patients had other chronic liver diseases (eg, alcoholic liver disease, autoimmune hepatitis, severe metabolic liver disease, toxic liver disease); 3) Cirrhosis or decompensated cirrhosis, 4) Tumors of other systems; 5) Severe complication in other organs; 6) Sever thyroid dysfunction or diabetes; 7) History of severe depression or known severe psychiatric disease; 8) Drug abuse; 9) Pregnant women and lactating women or patients who have pregnancy plans and are unwilling to contraception during the study period; 10) Allergyto interferon or a component of the tested product; 11) Participate in other clinical researchers at the same time; 12) The investigators considered it inappropriate for patients to participate in the study.

Design outcomes

Primary

MeasureTime frame
HBsAg quantification;HBsAb quantification;

Secondary

MeasureTime frame
HBV DNA quantification;ALT;AST;

Countries

China

Contacts

Public ContactShuangsuo Dang

The Second Affiliated Hospital of Xi'an Jiaotong University

dang212@126.com+86 13992896471

Outcome results

None listed

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