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.
Study Type
OBSERVATIONAL
Enrollment
5,000
ETV、TDF、TAF、TAF、IFN-a-2b
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
Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period
Number of Participants with Diagnosis of hepatocellular carcinoma
Time frame: 5 years
Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period
Number of Participants with Diagnosis of participants with decompensation cirrhosis
Time frame: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
Number of Participants with Diagnosis of participants with liver transplantation during the observation period
Number of Participants with Diagnosis of participants with liver transplantation
Time frame: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
Number of Participants with Diagnosis of participants with fibrosis regression and progression during the observation period
Number of Participants with Diagnosis of participants with fibrosis regression and progression
Time frame: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
Number of Participants with Diagnosis of participants with serological response during the observation period
Hepatitis B s Antigen (HBsAg) Loss, seroconversion to HBsAg, Hepatitis B s Antigen (HBeAg) Loss (only patients who are HBeAg positive at baseline), and seroconversion to HBeAg
Time frame: Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240
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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