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A prospective, multi-center study on application of interferon therapy in inactive HBsAg carriers to achieve clinical cure

A prospective, multi-center study on application of interferon therapy in inactive HBsAg carriers to achieve clinical cure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059576
Enrollment
Unknown
Registered
2022-05-04
Start date
2022-05-01
Completion date
Unknown
Last updated
2024-03-18

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

Conditions

None listed

Interventions

Group 1:PegIFNa-2b± Propofol tenofovir fumarate tablets (TAF) for continuous treatment
Group 2:PegIFNa-2b± Propofol tenofovir fumarate tablets (TAF) intermittent treatment
Control group:None

Sponsors

Beijing You'an Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-60 years (including 18 and 60 years old); 2. HBsAg positive >6 months, continuous HBsAg < 1000IU/ml, HBeAg negative, anti-HBC positive; 3. HBV DNA persistence < 2000IU/ml; 4. ALT remains normal (<40U/L) (Note: ''Continuous'' is defined as at least two tests within a year, with an interval of 3-6 months).

Exclusion criteria

Exclusion criteria: 1. Patients with HAV, HCV, HDV, HEV infection and autoimmune liver disease; 2. Pregnant and lactating patients and patients who plan to give birth recently; 3. History of serious heart disease, including unstable or uncontrolled heart disease within 6 months; 4. History of mental illness; 5. Uncontrolled seizures; 6. Alcohol or drug abusers in remission; 7. Uncontrolled diabetes, hypertension, thyroid disease, retinopathy, autoimmune disease, etc.; 8. Total bilirubin >34umol/L; 9. Patients with previous or current liver cirrhosis or liver cancer confirmed by liver ultrasound or liver stiffness measurement; 10. Neutrophil counts < 2x10^9 /L and/or platelet counts < 100x10^9 /L.

Design outcomes

Primary

MeasureTime frame
hepatitis B surface antigen clearance;

Secondary

MeasureTime frame
hepatitis B virus DNA;liver stiffness;cirrhosis;hepatocellular carcinoma;hepatitis B virus RNA;hepatic cccDNA;

Countries

China

Contacts

Public ContactChen Xinyue
chenxydoc@163.com+86 10 83997131

Outcome results

None listed

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