Clinical trial NCT05102838: Prospective Cohort Study on Prognosis of Patients With Hepatitis B/C
Official title: Prospective Cohort Study on Prognosis of Patients With Hepatitis B/C in Hainan Province Danzhou City
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hepatitis B
Hepatitis C
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-02
Enrollment: 60000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hepatitis B or hepatitis C patients will be enrolled in this study.

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients who refused to participate in the study.

Primary outcomes:
measure: Epidemiological characteristics of hepatitis B and C
timeFrame: up to 192 weeks
measure: Long-term outcome
timeFrame: up to 192 weeks
measure: Risk factors
timeFrame: up to 192 weeks
Secondary outcomes:
measure: Incidence of cirrhosis
timeFrame: up to 192 weeks
measure: Incidence of liver cancer
timeFrame: up to 192 weeks
measure: Hepatic decompensation
timeFrame: up to 192 weeks
measure: Survival rate for liver cancer
timeFrame: up to 192 weeks
measure: Survival rate for cirrhosis
timeFrame: up to 192 weeks
measure: HBV interruption rate of perinatal transmission
timeFrame: up to 192 weeks
measure: HBsAg loss
timeFrame: up to 192 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Bingliang Lin, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).