Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis
NCT ID: NCT05086536
Last Updated: 2021-10-21
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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UNKNOWN
600 participants
OBSERVATIONAL
2021-10-15
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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early stage decompensation cohort
Patients occurred first decompensated events and initiating nucleoside analogs (NUCs) based treatment within 3 months were retrospectively included.
no intervention
This is a retrospective and observational study.
Interventions
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no intervention
This is a retrospective and observational study.
Eligibility Criteria
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Inclusion Criteria
2. Initiating antiviral therapy within 3 months of the first decompensated events;
3. Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS,
4. Clinical outcomes were classified:
1. Without further decompensation: medical records at year-1, year 2 to 4, and year-5 were available.
2. With ≥ 2 episodes of decompensation: medical records for decompensation were available.
Exclusion Criteria
2. Liver transplantation /death within 6 months of first decompensated events;
3. complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD.
4. Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases;
5. Pregnant women.
ALL
No
Sponsors
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Beijing YouAn Hospital
OTHER
Shandong Provincial Hospital
OTHER_GOV
The Affiliated Hospital of Qingdao University
OTHER
The First Affiliated Hospital of Shanxi Medical University
OTHER
Xiangya Hospital of Central South University
OTHER
The Second Affiliated Hospital of Baotou Medical College
OTHER
Beijing Friendship Hospital
OTHER
Responsible Party
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Hong You
Vice director
Principal Investigators
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Hong You, Doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospita
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China
XiangYa Hospital Central South University
Changsha, Hunan, China
The Second Affiliated Hospital of Baotou Medical Coll
Baotou, Inner Mongolia, China
Shandong Provincial Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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Jang JW, Choi JY, Kim YS, Woo HY, Choi SK, Lee CH, Kim TY, Sohn JH, Tak WY, Han KH. Long-term effect of antiviral therapy on disease course after decompensation in patients with hepatitis B virus-related cirrhosis. Hepatology. 2015 Jun;61(6):1809-20. doi: 10.1002/hep.27723. Epub 2015 Mar 18.
Belli LS, Berenguer M, Cortesi PA, Strazzabosco M, Rockenschaub SR, Martini S, Morelli C, Donato F, Volpes R, Pageaux GP, Coilly A, Fagiuoli S, Amaddeo G, Perricone G, Vinaixa C, Berlakovich G, Facchetti R, Polak W, Muiesan P, Duvoux C; European Liver and Intestine Association (ELITA). Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: A European study. J Hepatol. 2016 Sep;65(3):524-31. doi: 10.1016/j.jhep.2016.05.010. Epub 2016 May 17.
Pascasio JM, Vinaixa C, Ferrer MT, Colmenero J, Rubin A, Castells L, Manzano ML, Lorente S, Testillano M, Xiol X, Molina E, Gonzalez-Dieguez L, Oton E, Pascual S, Santos B, Herrero JI, Salcedo M, Montero JL, Sanchez-Antolin G, Narvaez I, Nogueras F, Giraldez A, Prieto M, Forns X, Londono MC. Clinical outcomes of patients undergoing antiviral therapy while awaiting liver transplantation. J Hepatol. 2017 Dec;67(6):1168-1176. doi: 10.1016/j.jhep.2017.08.008. Epub 2017 Aug 24.
Perricone G, Duvoux C, Berenguer M, Cortesi PA, Vinaixa C, Facchetti R, Mazzarelli C, Rockenschaub SR, Martini S, Morelli C, Monico S, Volpes R, Pageaux GP, Fagiuoli S, Belli LS; European Liver and Intestine Transplant Association (ELITA). Delisting HCV-infected liver transplant candidates who improved after viral eradication: Outcome 2 years after delisting. Liver Int. 2018 Dec;38(12):2170-2177. doi: 10.1111/liv.13878. Epub 2018 May 25.
Other Identifiers
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2021-P2-224-01
Identifier Type: -
Identifier Source: org_study_id