Predictive Value of HBV pgRNA on Long-term Outcomes in Hepatitis B Patients Treated With Antiviral Therapy
NCT ID: NCT05965388
Last Updated: 2023-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
5000 participants
OBSERVATIONAL
2023-12-01
2029-02-01
Brief Summary
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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
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Chronic hepatitis B patients treated with nucleoside analogues or interferon
Chronic hepatitis B patients treated with nucleoside analogues or interferon
nucleoside analogues or interferon
ETV、TDF、TAF、TAF、IFN-a-2b
Interventions
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nucleoside analogues or interferon
ETV、TDF、TAF、TAF、IFN-a-2b
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
First Affiliated Hospital Xi'an Jiaotong University
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
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
Wen-hong Zhang
OTHER
Responsible Party
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Wen-hong Zhang
Director of Division ofInfectious Diseases Affiliation: Huashan Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ying Ye
Role: primary
Yuekai Hu, M.D.
Role: primary
Xuebing Yan, M.D.
Role: primary
Wanhua Ren
Role: primary
Ying Guo
Role: primary
Yingli He, M.D.
Role: primary
Jiawei Geng, M.D.
Role: primary
Wenhong Zhang, Professor
Role: primary
Feng Sun, doctor
Role: backup
References
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Lim TH, Gane E, Moyes C, Borman B, Cunningham C. HBsAg loss in a New Zealand community study with 28-year follow-up: rates, predictors and long-term outcomes. Hepatol Int. 2016 Sep;10(5):829-37. doi: 10.1007/s12072-016-9709-6. Epub 2016 Mar 8.
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Tan G, Yi Z, Song H, Xu F, Li F, Aliyari R, Zhang H, Du P, Ding Y, Niu J, Wang X, Su L, Qin FX, Cheng G. Type-I-IFN-Stimulated Gene TRIM5gamma Inhibits HBV Replication by Promoting HBx Degradation. Cell Rep. 2019 Dec 10;29(11):3551-3563.e3. doi: 10.1016/j.celrep.2019.11.041.
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Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.
Reijnders JG, Rijckborst V, Sonneveld MJ, Scherbeijn SM, Boucher CA, Hansen BE, Janssen HL. Kinetics of hepatitis B surface antigen differ between treatment with peginterferon and entecavir. J Hepatol. 2011 Mar;54(3):449-54. doi: 10.1016/j.jhep.2010.07.046. Epub 2010 Nov 5.
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Other Identifiers
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COMPASS by REASON
Identifier Type: -
Identifier Source: org_study_id