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Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis

China600 participantsStarted 2021-10-15

Plain-language summary

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.

Who can participate

SexALL

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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;

What they're measuring

Cumulative incidence of re-compensation

Timeframe: Year 5

Trial details

NCT IDNCT05086536

SponsorBeijing Friendship Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-01

Contact for this trial

Hong You, Doctor

861063139019 youhong30@sina.com

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