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Study on the mechanism of functional cure of High-dose hepatitis B vaccine combined with Long-acting interferon in patients with chronic hepatitis B and low HBsAg

Study on the mechanism of functional cure of High-dose hepatitis B vaccine combined with Long-acting interferon in patients with chronic hepatitis B and low HBsAg

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600121635
Enrollment
Unknown
Registered
2026-04-01
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Chronic viral hepatitis B

Interventions

Group B :polyethylene glycol interferon a-2b
Group C :60 µg hepatitis B vaccine
Group A :Pegylated interferon a-2b and 60ug hepatitis B vaccine group
Group D :Non-intervention

Sponsors

Xixi Hospital of Hangzhou
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18 to 70 years old; 2. For newly diagnosed or previously treated patients with chronic hepatitis B: HBsAg(+)<10IU/ml,HBV DNA<10IU/ml,HBeAg(-); Or those who have been confirmed to have had chronic HBV infection in the past, and after interferon treatment, HBsAg has turned negative but HBsAb has not been produced. 3. Those who can strictly abide by the requirements of clinical trials.

Exclusion criteria

Exclusion criteria: 1. There are other causes of active liver disease, including coexisting HCV, HDV, HIV infection or autoimmune hepatitis, fatty liver; 2. Clinical manifestations of liver cirrhosis or decompensated liver diseases, including previous esophageal variceal bleeding, ascites, hepatic encephalopathy, etc. 3. Those with a history of tumors or severe or uncontrolled other systemic diseases, including heart, lung, kidney, digestive, endocrine, nervous, and mental disorders, etc. 4. Those who plan to receive organ transplants or have already undergone organ transplants; 5. Those who are allergic to pegylated interferon a-2b or any component in the vaccine, or have a history of severe allergies in the past; 6. Pregnant and lactating female patients; 7. Interferon treatment group, with neutrophil count < 2×10^9 /L and/or platelet count < 100×10^9 /L; 8. Those that the researchers consider not to meet the requirements of clinical research.

Design outcomes

Primary

MeasureTime frame
HBsAg clearance rate;HBsAg conversion rate;

Secondary

MeasureTime frame
Dynamic monitoring of key indicators such as blood routine, liver function, hepatitis B three strains, HBV DNA, HBV RNA, and lymphocyte subsets.;adverse reaction;

Countries

China

Contacts

Public ContactZhang Xiaojing

Xixi Hospital of Hangzhou

qt_zhangxiaojing@163.com+86 571 86481719

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026