Re-compensation and Its Clinical Characteristics in HBV D... | NCT05086536

Studies
Re-compensation and Its Clinical Characteristics in HBV Decompensated Cirrhosis

NCT05086536

Sponsor

Beijing Friendship Hospital

Status

Unknown status

Last Update Posted

Oct 21, 2021Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Hepatitis B
Decompensated Cirrhosis

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2021Estimated

Primary Completion Date

Jun 1, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

Sep 19, 2021

First Submission Date that Met QC Criteria

Oct 7, 2021

First Posted Date

Oct 21, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2021

Last Update Posted Date

Oct 21, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hong You, Vice director, Beijing Friendship HospitalPrincipal Investigator

Lead Sponsor

Beijing Friendship HospitalOTHER

Collaborators

Name	Class
Beijing YouAn Hospital	OTHER
Shandong Provincial Hospital	OTHER_GOV
The Affiliated Hospital of Qingdao University	OTHER
The First Affiliated Hospital of Shanxi Medical University

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	This is a retrospective and observational study.	early stage decompensation cohort

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Cumulative incidence of re-compensation	Patients who did not occur further decompensation	Year 1, 2, 3, and 4
Annual incidence of second decompensation	Patients who occurred second decompensation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:
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:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hong You, Doctor	Contact	861063139019		youhong30@sina.com
Jialing Zhou, Master	Contact	010-63138665		zhoujialing11@126.com

Overall Officials

Name	Affiliation	Role
Hong You, Doctor	Beijing Friendship Hospita	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Friendship Hospital, Capital Medical University		Beijing	Beijing Municipality	100050	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25627342	Background	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.
27212241	Background

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections