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| Name | Class |
|---|---|
| Shandong Provincial Hospital | OTHER_GOV |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic hepatitis B patients treated with nucleoside analogues or interferon | Chronic hepatitis B patients treated with nucleoside analogues or interferon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nucleoside analogues or interferon | Drug | ETV、TDF、TAF、TAF、IFN-a-2b |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Diagnosis of hepatocellular carcinoma during the observation period | Number of Participants with Diagnosis of hepatocellular carcinoma | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Diagnosis of participants with decompensation cirrhosis during the observation period | Number of Participants with Diagnosis of participants with decompensation cirrhosis | Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240 |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhong Zhang, MD | Contact | 13801844344 | zhangwenhong@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26231459 | Background | Schweitzer A, Horn J, Mikolajczyk RT, Krause G, Ott JJ. Estimations of worldwide prevalence of chronic hepatitis B virus infection: a systematic review of data published between 1965 and 2013. Lancet. 2015 Oct 17;386(10003):1546-55. doi: 10.1016/S0140-6736(15)61412-X. Epub 2015 Jul 28. | |
| 31941257 | Background |
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| ID | Term |
|---|---|
| D007372 | Interferons |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| First Affiliated Hospital of Fujian Medical University |
| OTHER |
| The Third People's Hospital of Taiyuan | OTHER |
| The First People's Hospital of Yunnan | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
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Collect the serum samples of CHB patients receiving antiviral therapy during long-term follow-up, and detect the concentration of HBV pgRNA in the samples
| Number of Participants with Diagnosis of participants with liver transplantation during the observation period |
Number of Participants with Diagnosis of participants with liver transplantation |
| 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 | 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 | Week 4, Week 12, Week24, Week36, Week48, Week72, Week96, Week120, Week144, Week168, Week192, Week216 and Week240 |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | 350004 | China |
|
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 210000 | China |
| the Affiliated Hosptial of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | 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 | 710061 | China |
|
| The First People's Hospital Of YunNan | Kunming | Yunnan | 650100 | China |
|
| Huashan Hospital | Shanghai | 200040 | China |
|
| Chinese Society of Infectious Diseases, Chinese Medical Association; Chinese Society of Hepatology, Chinese Medical Association. [The guidelines of prevention and treatment for chronic hepatitis B (2019 version)]. Zhonghua Gan Zang Bing Za Zhi. 2019 Dec 20;27(12):938-961. doi: 10.3760/cma.j.issn.1007-3418.2019.12.007. Chinese. |
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| 27374637 | Background | Shin EC, Sung PS, Park SH. Immune responses and immunopathology in acute and chronic viral hepatitis. Nat Rev Immunol. 2016 Aug;16(8):509-23. doi: 10.1038/nri.2016.69. Epub 2016 Jul 4. |
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| D011506 | Proteins |
| D001685 | Biological Factors |