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ClinicalTrials.gov ID

NCT05086536

Lead Sponsor

Beijing Friendship HospitalOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

600Estimated

Last Update Posted

Oct 21, 2021Actual

Start Date

Oct 15, 2021Estimated

Primary Completion Date

Jun 1, 2022Estimated

Completion Date

Dec 30, 2022Estimated

Official Title

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

Brief 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.

Detailed 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.

• Hepatitis B
• Decompensated Cirrhosis

• no intervention

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Cohort

Time Perspective

Retrospective

Lead Sponsor

Beijing Friendship HospitalOTHER

Collaborators

Beijing YouAn HospitalOTHER

Shandong Provincial HospitalOTHER_GOV

The Affiliated Hospital of Qingdao UniversityOTHER

The First Affiliated Hospital of Shanxi Medical UniversityOTHER

Xiangya Hospital of Central South UniversityOTHER

The Second Affiliated Hospital of Baotou Medical CollegeOTHER

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