NCT05102838

Brief Summary

Hepatitis B (HBV) and hepatitis C (HCV) are prevalent all over the world, which seriously threatens public health. In 2016, the World Health Organization(WHO) put forward the goal of eliminating the threat of viral hepatitis to public health by 2030. However, at present, the diagnosis rate and treatment rate of chronic HBV and HCV in China are still far from the goal put forward by WHO. Therefore, for China, the elimination of viral hepatitis is still a public health problem that needs a long time to face. This study aims to screen and follow up HBV and HCV patients in Danzhou City, Hainan Province, so as to understand the epidemiological characteristics and long-term prognosis of HBV/HCV patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

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

First Submitted

Initial submission to the registry

October 20, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

3.8 years

First QC Date

October 20, 2021

Last Update Submit

October 20, 2021

Conditions

Hepatitis BHepatitis C

Outcome Measures

Primary Outcomes (3)

  • Epidemiological characteristics of hepatitis B and C

    Epidemiological characteristics of hepatitis B and C in Danzhou City, Hainan Province

    up to 192 weeks

  • Long-term outcome

    Long-term outcome of HBV/HCV infected patients in Danzhou City, Hainan Province

    up to 192 weeks

  • Risk factors

    Risk factors for long-term outcome of HBV/HCV infected patients in Danzhou City, Hainan Province

    up to 192 weeks

Secondary Outcomes (7)

  • Incidence of cirrhosis

    up to 192 weeks

  • Incidence of liver cancer

    up to 192 weeks

  • Hepatic decompensation

    up to 192 weeks

  • Survival rate for liver cancer

    up to 192 weeks

  • Survival rate for cirrhosis

    up to 192 weeks

  • +2 more secondary outcomes

Study Arms (4)

Hepatitis B cohort

1. Patients with HBsAg and/or HBV DNA positive; 2. Patients without cirrhosis.

Other: Anti-virus treatment

Hepatitis C cohort

1. Patients with anti-HCV and/or HCV RNA positive; 2. Patients without cirrhosis.

Other: Anti-virus treatment

Cirrhosis cohort

1. Patients diagnosised with cirrhosis; 2. Patients with HBsAg, and/or HBV DNA, and/or anti-HCV and/or HCV RNA positive.

Other: Anti-virus treatment

Liver cancer cohort

1. Patients diagnosised with liver cancer; 2. Patients with HBsAg, and/or HBV DNA, and/or anti-HCV and/or HCV RNA positive.

Other: Anti-virus treatment

Interventions

Anti-virus treatmentOTHER

Anti-virus treatment

Cirrhosis cohortHepatitis B cohortHepatitis C cohortLiver cancer cohort

Eligibility Criteria

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

Hepatitis B or hepatitis C patients will be enrolled in this study.

You may qualify if:

  • HBsAg/HBV DNA positive
  • or anti-HCV/HCV RNA positive

You may not qualify if:

  • patients who refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1.Lu FM, Zhuang H. Management of hepatitis B in China[J]. Chin Med J ( Engl) , 2009, 122(1): 3-4． 2.Chen YS, Li L, Cui FQ et al. Seroepidemiological study of hepatitis C in China[J].Chinese Journal of Epidemiology, 2011, 32:888-891. 3.Wang FS, Fan JG, Zhang Z, et al. The global burden of liver disease: the major impact of China[J]. Hepatology, 2014, 60(6): 2099 -2108． 4.Huang YW, Yang SS, Fu SC, et al. Increased risk of cirrhosis and its decompensation in chronic hepatitis C patients with new-onset diabetes: a nationwide cohort study[J]. Patology, 2014,60:807-814. 5.69th World Health Assembly. Draft Global Health Sector Strategies. April 2016. Available at: http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_32-en.pdf?ua=1 (accessed February 2017) 6.Global Hepatitis Report, 2017. http://www.who.int/mediacentre/factsheets/fs164/zh. 7.CDA Foundation's Polaris Observatory; 2020 Available from https://cdafound.org/polaris/ (Accessed 2020-06-09).

    BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be retained at each timepoints.

MeSH Terms

Conditions

Hepatitis BHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesFlaviviridae InfectionsRNA Virus Infections

Study Officials

  • Bingliang Lin, Dr.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junfeng Chen, Dr.

CONTACT

86-20-85252363mountainchen@139.com

Study Design

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

Study Record Dates

First Submitted

October 20, 2021

First Posted

November 2, 2021

Study Start

November 1, 2021

Primary Completion

August 30, 2025

Study Completion

March 31, 2026

Last Updated

November 2, 2021

Record last verified: 2021-10