Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis

October 7, 2021 updated by: Hong You, Beijing Friendship Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Friendship Hospital, Capital Medical University
        • Principal Investigator:
          • Hong You, Doctor
        • Contact:
        • Contact:
      • Beijing, Beijing, China, 10069
        • Beijing Youan Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Zhongjie Hu
    • Hunan
      • Changsha, Hunan, China, 410011
        • Xiangya Hospital Central South University
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • The Second Affiliated Hospital of Baotou Medical Coll
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Chunqing Zhang, Docote
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital of Qingdao University
        • Contact:
        • Principal Investigator:
          • Wei Rao, Docotr
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • First Hospital of Shanxi Medical University
        • Contact:
        • Principal Investigator:
          • Yanqin Hao, Doctor
        • Principal Investigator:
          • Liaoyun Zhang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

HBV-decompensated cirrhosis patients who occurred first decompensated events and initiated antiviral therapy within 3 months.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Collaborators

Xiangya Hospital of Central South University
Beijing YouAn Hospital
The Affiliated Hospital of Qingdao University
Shandong Provincial Hospital
The First Affiliated Hospital of Shanxi Medical University
The Second Affiliated Hospital of Baotou Medical College

Investigators

  • Principal Investigator: Hong You, Doctor, Beijing Friendship Hospita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

September 19, 2021

First Submitted That Met QC Criteria

October 7, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-P2-224-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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