Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis

Study Overview
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Brief Summary
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In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. Clinical data from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. In this retrospective study, the incidence of re-compensation and its clinical characteristics were mainly explored.

Detailed Description
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In this study, treatment-naïve HBV-related cirrhosis patients were retrospectively enrolled at the first episode of decompensation (ascites or variceal hemorrhage). Patients were followed up every 6 months until death /liver transplantation or for 5 years. WBC, RBC, HGB, PLT, CRP, PT, PTA, INR, ALT, AST, TB, DB, ALB, GLO, ALP, GGT, CHE, BUN, Cr, Na, GLU, CHOL, TG, HDL-C, LDL-C, AFP, HBsAg, HBV-DNA, LSM, BUS, MRI/CT and gastroscope from medical records about past history, first decompensated events, second /further decompensated events, HCC, and death/ liver transplantation were retrospectively collected. This retrospective study aimed to explore the incidence of re-compensation and its clinical characteristics.

Official Title
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Re-compensation and Its Clinical Characteristics in Treatment-naïve HBV Decompensated Cirrhosis on Antiviral Therapy

Conditions
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Hepatitis B, Decompensated Cirrhosis

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ascites and/or variceal hemorrhage (VH) as the first decompensated events; Initiating antiviral therapy within 3 months of the first decompensated events; Clinical parameters were available at the first decompensated events, including PLT, ALT, ALB, TB, PT/INR, Cr, HBV DNA, BUS, Clinical outcomes were classified: Without further decompensation: medical records at year-1, year 2 to 4, and year-5 were available. With ≥ 2 episodes of decompensation: medical records for decompensation were available. Exclusion Criteria: Hepatocellular carcinoma prior to /within 6 months of first decompensated events; Liver transplantation /death within 6 months of first decompensated events; complicated with other chronic liver diseases, including HCV, DILI, AIH, NAFLD, ALD. Any complication of severe heart, lung, kidney, brain, blood diseases or other severe systematic diseases; Pregnant women.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| early stage decompensation cohort<br>Patients occurred first decompensated events and initiating nucleoside analogs (NUCs) based treatment within 3 months were retrospectively included. | Other: no intervention<br>* This is a retrospective and observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of re-compensation | Patients who did not occur further decompensation | Year 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of re-compensation | Patients who did not occur further decompensation | Year 1, 2, 3, and 4 | 
| Annual incidence of second decompensation | Patients who occurred second decompensation | Year 1, 2, 3, 4, and 5 | 
| Cumulative incidence of liver-related death / liver transplantation | Patients who died of decompensation | Year 1, 2, 3, 4, and 5 | 
| Cumulative incidence of HCC | Patients who occurred HCC | Year 1, 2, 3, 4, and 5 | 
| Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group | Child-Pugh | Year 1, 2, 3, 4, and 5 | 
| Dynamic changes of MELD score in re-compensated and not re-compensated group | MELD | Year 1, 2, 3, 4, and 5 | 
| Dynamic changes of APRI score in re-compensated and not re-compensated group | APRI | Year 1, 2, 3, 4, and 5 | 
| Dynamic changes of FIB-4 score in re-compensated and not re-compensated group | FIB-4 | Year 1, 2, 3, 4, and 5 | 
| Dynamic changes of liver stiffness values measured by Transient Elastography in re-compensated and not re-compensated group | Liver stiffness | Year 1, 2, 3, 4, and 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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re-compensation, treatment-naive, HBV, decompensation