Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis

Capital Medical University

Status: Unknown

Conditions: Decompensated Cirrhosis; Hepatitis B

Treatments: Other: no intervention

Study type: Observational

Funder types: Other

Identifiers

NCT05086536

2021-P2-224-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Ascites and/or variceal hemorrhage (VH) as the first decompensated events;

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

1. Hepatocellular carcinoma prior to /within 6 months of first decompensated events;
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.

Trial design

600 participants in 1 patient group

early stage decompensation cohort

Description:

Patients occurred first decompensated events and initiating nucleoside analogs (NUCs) based treatment within 3 months were retrospectively included.

Treatment:

Other: no intervention