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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05102838
• Other study ID #: Spark Srudy
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: October 2021
• Source: Sun Yat-sen University
• Contact: Junfeng Chen, Dr.
• Phone: 86-20-85252363
• Email: mountainchen[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60000
• Est. completion date: March 31, 2026
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• HBsAg/HBV DNA positive

• or anti-HCV/HCV RNA positive

Exclusion Criteria:

• patients who refused to participate in the study.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C

Intervention

Other:
• Anti-virus treatment
Anti-virus treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

References & 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).

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiological characteristics of hepatitis B and C	Epidemiological characteristics of hepatitis B and C in Danzhou City, Hainan Province	up to 192 weeks
Primary	Long-term outcome	Long-term outcome of HBV/HCV infected patients in Danzhou City, Hainan Province	up to 192 weeks
Primary	Risk factors	Risk factors for long-term outcome of HBV/HCV infected patients in Danzhou City, Hainan Province	up to 192 weeks
Secondary	Incidence of cirrhosis	Incidence of cirrhosis for HBV/HCV infected patients in Danzhou City, Hainan Province	up to 192 weeks
Secondary	Incidence of liver cancer	ncidence of liver cirrhosis for HBV/HCV infected patients in Danzhou City, Hainan Province	up to 192 weeks
Secondary	Hepatic decompensation	Hepatic decompensation rate for HBV/HCV infected patients in Danzhou City, Hainan Province	up to 192 weeks
Secondary	Survival rate for liver cancer	Survival rate for liver cancer patients in Danzhou City, Hainan Province	up to 192 weeks
Secondary	Survival rate for cirrhosis	Survival rate for cirrhosis patients in Danzhou City, Hainan Province	up to 192 weeks
Secondary	HBV interruption rate of perinatal transmission	HBV interruption rate of perinatal transmission in Danzhou City, Hainan Province	up to 192 weeks
Secondary	HBsAg loss	The HBsAg loss rate of HBV infected patients in Danzhou City, Hainan Province	up to 192 weeks