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

NCT ID: NCT05102838

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-01

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis B Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hepatitis B cohort

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

Anti-virus treatment

Intervention Type OTHER

Anti-virus treatment

Hepatitis C cohort

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

Anti-virus treatment

Intervention Type 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.

Anti-virus treatment

Intervention Type 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.

Anti-virus treatment

Intervention Type OTHER

Anti-virus treatment

Interventions

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Anti-virus treatment

Anti-virus treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients who refused to participate in the study.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Lin Bingliang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bingliang Lin, Dr.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Central Contacts

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Junfeng Chen, Dr.

Role: CONTACT

Phone: 86-20-85252363

Email: [email protected]

References

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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).

Reference Type BACKGROUND

Other Identifiers

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Spark Srudy

Identifier Type: -

Identifier Source: org_study_id