NCT06596213

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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
63mo left

Started Oct 2024

Longer than P75 for all trials

Status
not yet recruiting

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

Study Progress24%
Oct 2024Jun 2031

First Submitted

Initial submission to the registry

September 11, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

September 19, 2024

Status Verified

July 1, 2024

Enrollment Period

6.3 years

First QC Date

September 11, 2024

Last Update Submit

September 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Safety

    Time from diagnosis of hepatitis to treatment.

    From 1 January 2000 to 31 March 2024

Secondary Outcomes (1)

  • Safety

    From 1 January 2000 to 31 March 2024

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 22537432BACKGROUND

Related Links

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

September 11, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

June 30, 2031

Last Updated

September 19, 2024

Record last verified: 2024-07