NCT05965388

Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Wen-hong Zhang · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective, exploratory, non-intervention, multi-center, real-world study is to investigate the predictive value of HBV pgRNA in the occurrence of long-term outcomes under antiviral therapy in patients with chronic hepatitis B. Participants will take the necessary clinical examination and blood draw during the patient's treatment and follow-up, and all the treatment is determined by clinicians.

Detailed description

This study is a prospective, exploratory, multi-center, real-world study, with Huashan Hospital as the leading unit. The study includes patients with chronic hepatitis B who have been determined by clinicians to start, or have already taken the first-line treatment { including pegylated interferon \[IFN\] monotherapy, a potent nucleos(t)ide analogue \[NA\] monotherapy, two different potent NAs combination therapy, or NA plus IFN combination therapy. The study only collects clinical data and serum samples, without imposing any additional intervention measures or affecting any relevant clinical decisions. The clinical data is collected from the patient's clinical follow-up examination data, without additional visits and auxiliary examinations. Sample collection During the necessary clinical examination and blood draw during the patient's treatment and follow-up, one additional serum separation tube (3ml) was drawn, without additional invasive examination for the patient. The study will follow up with patients for 5 years to explore the relationship between the serum HBV pgRNA level and the endpoint event at different time points.

Conditions

• HBV
• HCC

Interventions

Type	Name	Description
DRUG	nucleoside analogues or interferon	ETV、TDF、TAF、TAF、IFN-a-2b

Timeline

• Start date: 2023-12-01
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2023-07-28
• Last updated: 2023-07-28

Locations

10 sites across 1 country: China

Regulatory

• FDA-regulated drug study