NCT05086536

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 21, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 21, 2021

Status Verified

October 1, 2021

Enrollment Period

8 months

First QC Date

September 19, 2021

Last Update Submit

October 7, 2021

Conditions

Hepatitis BDecompensated Cirrhosis

Keywords

re-compensationtreatment-naiveHBVdecompensation

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of re-compensation

    Patients who did not occur further decompensation

    Year 5

Secondary Outcomes (9)

  • Cumulative incidence of re-compensation

    Year 1, 2, 3, and 4

  • Annual incidence of second decompensation

    Year 1, 2, 3, 4, and 5

  • Cumulative incidence of liver-related death / liver transplantation

    Year 1, 2, 3, 4, and 5

  • Cumulative incidence of HCC

    Year 1, 2, 3, 4, and 5

  • Dynamic changes of Child-Pugh score in re-compensated and not re-compensated group

    Year 1, 2, 3, 4, and 5

  • +4 more secondary outcomes

Study Arms (1)

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

Interventions

no interventionOTHER

This is a retrospective and observational study.

early stage decompensation cohort

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, 10069, China

Location

XiangYa Hospital Central South University

Changsha, Hunan, 410011, China

Location

The Second Affiliated Hospital of Baotou Medical Coll

Baotou, Inner Mongolia, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Related Publications (4)

  • Jang JW, Choi JY, Kim YS, Woo HY, Choi SK, Lee CH, Kim TY, Sohn JH, Tak WY, Han KH. Long-term effect of antiviral therapy on disease course after decompensation in patients with hepatitis B virus-related cirrhosis. Hepatology. 2015 Jun;61(6):1809-20. doi: 10.1002/hep.27723. Epub 2015 Mar 18.

    PMID: 25627342BACKGROUND

  • Belli LS, Berenguer M, Cortesi PA, Strazzabosco M, Rockenschaub SR, Martini S, Morelli C, Donato F, Volpes R, Pageaux GP, Coilly A, Fagiuoli S, Amaddeo G, Perricone G, Vinaixa C, Berlakovich G, Facchetti R, Polak W, Muiesan P, Duvoux C; European Liver and Intestine Association (ELITA). Delisting of liver transplant candidates with chronic hepatitis C after viral eradication: A European study. J Hepatol. 2016 Sep;65(3):524-31. doi: 10.1016/j.jhep.2016.05.010. Epub 2016 May 17.

    PMID: 27212241BACKGROUND

  • Pascasio JM, Vinaixa C, Ferrer MT, Colmenero J, Rubin A, Castells L, Manzano ML, Lorente S, Testillano M, Xiol X, Molina E, Gonzalez-Dieguez L, Oton E, Pascual S, Santos B, Herrero JI, Salcedo M, Montero JL, Sanchez-Antolin G, Narvaez I, Nogueras F, Giraldez A, Prieto M, Forns X, Londono MC. Clinical outcomes of patients undergoing antiviral therapy while awaiting liver transplantation. J Hepatol. 2017 Dec;67(6):1168-1176. doi: 10.1016/j.jhep.2017.08.008. Epub 2017 Aug 24.

    PMID: 28842296BACKGROUND

  • Perricone G, Duvoux C, Berenguer M, Cortesi PA, Vinaixa C, Facchetti R, Mazzarelli C, Rockenschaub SR, Martini S, Morelli C, Monico S, Volpes R, Pageaux GP, Fagiuoli S, Belli LS; European Liver and Intestine Transplant Association (ELITA). Delisting HCV-infected liver transplant candidates who improved after viral eradication: Outcome 2 years after delisting. Liver Int. 2018 Dec;38(12):2170-2177. doi: 10.1111/liv.13878. Epub 2018 May 25.

    PMID: 29750389BACKGROUND

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Hong You, Doctor

    Beijing Friendship Hospita

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong You, Doctor

CONTACT

861063139019youhong30@sina.com

Jialing Zhou, Master

CONTACT

010-63138665zhoujialing11@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice director

Study Record Dates

First Submitted

September 19, 2021

First Posted

October 21, 2021

Study Start

October 15, 2021

Primary Completion

June 1, 2022

Study Completion

December 30, 2022

Last Updated

October 21, 2021

Record last verified: 2021-10

Locations

CN(7)