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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.
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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
the Affiliated Hosptial of Xuzhou Medical University
Xuzhou, Jiangsu, China
Shandong Provincial Hospital of Shandong University
Jinan, Shandong, China
The Third People's Hospital of Taiyuan
Taiyuan, Shanxi, China
First Affiliated Hospital Xi'an Jiaotong University
Xi’an, Shanxi, China
The First People's Hospital Of YunNan
Kunming, Yunnan, China
Huashan Hospital
Shanghai, China
Start Date
December 1, 2023
Primary Completion Date
February 1, 2029
Completion Date
February 1, 2029
Last Updated
July 28, 2023
5,000
ESTIMATED participants
nucleoside analogues or interferon
DRUG
Lead Sponsor
Wen-hong Zhang
Collaborators
NCT07291076
NCT05581004
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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