Prospective Cohort Study on Prognosis of Patients With Hepatitis B/C

October 20, 2021 updated by: Lin Bingliang, Sun Yat-sen University

Prospective Cohort Study on Prognosis of Patients With Hepatitis B/C in Hainan Province Danzhou City

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatitis B (HBV) and hepatitis C (HCV) are prevalent all over the world, which seriously threatens public health. According to the survey, there are about 93 million chronic HBV infected people and 10 million chronic HCV infected people in China, accounting for 36.19% and 14.08% of the global HBV and HCV infected people respectively. Chronic HBV and HCV infection is the main cause of liver cirrhosis and liver cancer, which places a great burden on the national economy.

In 2016, the World Health Organization(WHO) put forward the goal of eliminating the threat of viral hepatitis to public health by 2030, including 90% diagnosis rate, 80% treatment rate and 90% cure rate of viral hepatitis, in order to reduce 65% of viral hepatitis related deaths and reduce the disease burden. However, at present, the diagnosis rate of chronic HBV in China is 18.7%, the treatment rate is 10.8%, the diagnosis rate of chronic HCV is 30%, and the treatment rate is 9%, which 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.

Study Type

Observational

Enrollment (Anticipated)

60000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • patients who refused to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatitis B cohort
  1. Patients with HBsAg and/or HBV DNA positive;
  2. Patients without cirrhosis.
Other: Anti-virus treatment
Anti-virus treatment
Hepatitis C cohort
  1. Patients with anti-HCV and/or HCV RNA positive;
  2. Patients without cirrhosis.
Other: Anti-virus treatment
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
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
Anti-virus treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological characteristics of hepatitis B and C
Time Frame: up to 192 weeks
Epidemiological characteristics of hepatitis B and C in Danzhou City, Hainan Province
up to 192 weeks
Long-term outcome
Time Frame: up to 192 weeks
Long-term outcome of HBV/HCV infected patients in Danzhou City, Hainan Province
up to 192 weeks
Risk factors
Time Frame: up to 192 weeks
Risk factors for long-term outcome of HBV/HCV infected patients in Danzhou City, Hainan Province
up to 192 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of cirrhosis
Time Frame: up to 192 weeks
Incidence of cirrhosis for HBV/HCV infected patients in Danzhou City, Hainan Province
up to 192 weeks
Incidence of liver cancer
Time Frame: up to 192 weeks
ncidence of liver cirrhosis for HBV/HCV infected patients in Danzhou City, Hainan Province
up to 192 weeks
Hepatic decompensation
Time Frame: up to 192 weeks
Hepatic decompensation rate for HBV/HCV infected patients in Danzhou City, Hainan Province
up to 192 weeks
Survival rate for liver cancer
Time Frame: up to 192 weeks
Survival rate for liver cancer patients in Danzhou City, Hainan Province
up to 192 weeks
Survival rate for cirrhosis
Time Frame: up to 192 weeks
Survival rate for cirrhosis patients in Danzhou City, Hainan Province
up to 192 weeks
HBV interruption rate of perinatal transmission
Time Frame: up to 192 weeks
HBV interruption rate of perinatal transmission in Danzhou City, Hainan Province
up to 192 weeks
HBsAg loss
Time Frame: up to 192 weeks
The HBsAg loss rate of HBV infected patients in Danzhou City, Hainan Province
up to 192 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Bingliang Lin, Dr., Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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).

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2021

Primary Completion (ANTICIPATED)

August 30, 2025

Study Completion (ANTICIPATED)

March 31, 2026

Study Registration Dates

First Submitted

October 20, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (ACTUAL)

November 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Spark Srudy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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