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A prospective, multicentre clinical study based on GOLDEN model to guide nucleoside (acid) sequential combination with pegylated interferon for clinical cure of chronic hepatitis B patients

A prospective, multicentre clinical study based on GOLDEN model to guide nucleoside (acid) sequential combination with pegylated interferon for clinical cure of chronic hepatitis B patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095819
Enrollment
Unknown
Registered
2025-01-14
Start date
2025-01-14
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Chronic Hepatitis B

Interventions

Dominant population interferon group:None
Non-dominant population interferon group:None

Sponsors

Tangdu Hospital, Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: a. Male or female, aged 18-65 years; b.Maintain HBsAg positive for more than 6 months; c. With nucleoside (acid) treatment for more than half a year; d. qHBsAg with a clear test date can be provided at least 2 times within 5 years (in the same laboratory ); e.HBsAg was not cleared before interferon therapy; f. Willing to participate and sign informed consent.

Exclusion criteria

Exclusion criteria: a. Combined with other viral hepatitis, alcoholic liver disease, or autoimmune liver disease; b. Co-infection with HIV; c. Patients with decompensated cirrhosis (defined as Child-Pugh score >=7 or ascites, hepatorenal syndrome, hepatic encephalopathy, or gastrointestinal bleeding in the past 6 weeks); d. A history of diagnosis of hepatocellular carcinoma; e.With liver transplantation; f. Allergy to Peg-IFN-a; g. Evidence of acute severe liver damage: ALT>=10 ULN; h. Pregnant or lactating patients; i. A history of serious mental illness, especially depression; j. History of severe seizures or use anticonvulsant drugs currently; k. History of serious heart disease (such as NYHA level III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia requiring continued treatment, unstable angina, or other significant cardiovascular disease); l. Antinuclear antibody (ANA)>1:100, or a clear history of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis, Guillambarre, etc.); m. A history of thyroid disease that remains poorly controlled after standardized treatment, an increase in thyrotropin accompanied by an increase in thyroid peroxidase antibodies, and thyroid disease with clinical manifestations; n. History of severe retinopathy or clinically relevant eye disease (e.g. due to high blood pressure or diabetes, CMV retinitis, macular degeneration, high myopia).

Design outcomes

Primary

MeasureTime frame
HBsAg clearance;

Secondary

MeasureTime frame
HBsAg seroconversion rate;

Countries

China

Contacts

Public ContactKang Wen

Tangdu Hospital, Fourth Military Medical University

82399536@qq.com+86 136 7929 2959

Outcome results

None listed

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