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ClinicalTrials.gov ID

NCT05965388

Lead Sponsor

Wen-hong ZhangOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

5,000Estimated

Last Update Posted

Jul 28, 2023Actual

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Feb 1, 2029Estimated

Completion Date

Feb 1, 2029Estimated

Official Title

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

Brief 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.

• HBV
• HCC

• nucleoside analogues or interferon

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• CHB defined as positive hepatitis B surface antigen at least 6 months, or HBV-related histological changes within 1 year if HBsAg positive less than 6 months;
• Age between 18-80 years, gender is not limited；
• 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;
• Patient who reads and signs informed consent.

Exclusion Criteria:

• Patients with malignancies other than hepatocellular carcinoma.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Wen-hong ZhangOTHER

Collaborators

Shandong Provincial HospitalOTHER_GOV

First Affiliated Hospital Xi'an Jiaotong UniversityOTHER

The Affiliated Hospital of Xuzhou Medical UniversityOTHER

First Affiliated Hospital of Fujian Medical UniversityOTHER

The Third People's Hospital of TaiyuanOTHER

The First People's Hospital of YunnanOTHER

The First Affiliated Hospital of Anhui Medical UniversityOTHER

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

The First Affiliated Hospital with Nanjing Medical UniversityOTHER

zhangwenhong@fudan.edu.cn13801844344