Hepatitis Inequalities Study | NCT06596213

Studies
Hepatitis Inequalities Study

NCT06596213

Sponsor

Chinese University of Hong Kong

Status

Not yet recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

100,000Estimated

Phase

Not provided

Conditions

Chronic Hepatitis B
HEPATITIS C VIRUS CHRONIC INFECTION

Interventions

Not provided

Countries

Not provided

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

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2024Estimated

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Jun 30, 2031Estimated

First Submitted Date

Sep 11, 2024

First Submission Date that Met QC Criteria

Sep 16, 2024

First Posted Date

Sep 19, 2024Actual

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

Sep 16, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Health inequality in liver diseases including age, gender, ethnicity and socioeconomic status has been increasingly recognised and potentially hinder hepatitis elimination. Health inequality has significant impact to evaluate the impact diagnostic and treatment uptake rates of chronic viral hepatitis on risk of hepatocellular carcinoma (HCC), hepatic event and liver-related death in patients with chronic hepatitis B and/or C. To overcome the limitation of small prospective cohort study of limited recruitment period, retrieving information from the Clinical Data Analysis and Reporting System (CDARS) from Hospital Authority (HA) will be one of the best way to answer these questions.

Detailed Description

Not provided

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

100,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety	Time from diagnosis of hepatitis to treatment.	From 1 January 2000 to 31 March 2024

Secondary Outcomes

Measure	Description	Time Frame
Safety	The composite endpoints of recurrence of hepatic events (e.g. HCC hepatic coma, portal hypertension, variceal bleeding, hepatorenal syndrome).	From 1 January 2000 to 31 March 2024

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients will be eligible if they have any of these viral markers (HBeAg / HBsAg / HBV DNA / HCV RNA) and/or any of the following diagnosis codes (ICD-9 070-070.9; 348.3, 349.82, 456, 456.2, 456.8, 567.2, 567.8, 570, 571.2, 571.5, 571.6, 572.2, 572.3, 572.4, 789.5) checked or coded in any public hospitals or clinics from 1 January 2000 to 31 March 2024.

Exclusion Criteria:

Patients with missing age, gender, ethnicity and socioeconomic status
(Subgroup analysis for ethnicity and socioeconomic status) Patients with missing ethnicity and socioeconomic status
Serious medical illnesses or malignancy with life expectancy <1 year

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

From the Clinical Data Analysis and Reporting System (CDARS) from Hospital Authority

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Angel Chim, MSc	Contact	852-35053759		angelchim@cuhk.edu.hk
Grace Wong, MD	Contact	852-35054205		wonglaihung@cuhk.edu.hk

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22537432	Background	El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012 May;142(6):1264-1273.e1. doi: 10.1053/j.gastro.2011.12.061.

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections