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Prospective study protocol for predicting clinical cure of CHB with PegIFNa-2b based on baseline and early treatment peripheral blood CD4+PD-1+ and CD8+PD-1+ T cell levels

Prospective study protocol for predicting clinical cure of CHB with PegIFNa-2b based on baseline and early treatment peripheral blood CD4+PD-1+ and CD8+PD-1+ T cell levels

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600118395
Enrollment
Unknown
Registered
2026-02-04
Start date
2025-07-30
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Chronic hepatitis B

Interventions

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. HBsAg positive and HBeAg negative; 2. All participants had not used interferon antiviral therapy before enrollment; 3. The diagnosis met the diagnostic criteria of the 2022 revised Guidelines for the prevention and treatment of chronic hepatitis B; 4. Voluntarily cooperate to complete the follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnancy or planned pregnancy in the near future; 2. Underlying diseases such as psychiatric history (schizophrenia or severe depression), uncontrolled epilepsy, unabstinent alcohol/drug addict, uncontrolled autoimmune disease, decompensated liver cirrhosis, thyroid disease, severe infection, retinal disease, heart failure, chronic obstructive pneumonia, etc.; 3. Neutrophil count < 1.0×10^9/L and platelet count < 50×10^9/L before treatment. (Note: Ultrasound or CT is used to rule out cirrhosis.)

Design outcomes

Primary

MeasureTime frame
Peripheral blood CD4+PD-1+T level;Peripheral blood CD8+PD-1+T level;Serum HBsAg levels;Serum HBV DNA levels;Serum HBV RNA levels;

Secondary

MeasureTime frame
Serum Albumin;Bilirubin;Alpha-fetoprotein;Self-Rating Depression Scale (SDS);Liver ultrasound for monitoring cirrhosis;Number and size of hepatic nodules;APRI (AST-to-Platelet Ratio Index);FIB-4 (Fibrosis-4 Index);GPR (Gamma-Glutamyl Transferase-to-Platelet Ratio);

Countries

China

Contacts

Public ContactEnqiang Chen

West China Hospital, Sichuan University

chenenqiang1983@hotmail.com+86 189 8060 6517

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026