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

Not yet recruiting

• Conditions: Hepatitis B; Hepatitis C
• Interventions: Other: Anti-virus treatment

• Registration Number: NCT05102838
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Last Update Submitted: 2021-10-20
• Study Start: 2021-11-01
• Study First Posted: 2021-11-02
• Last Update Posted: 2021-11-02
• Primary Completion: 2025-08-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60000

Inclusion Criteria

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

Exclusion Criteria

• patients who refused to participate in the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatitis B cohort	Anti-virus treatment	1. Patients with HBsAg and/or HBV DNA positive; 2. Patients without cirrhosis.
Hepatitis C cohort	Anti-virus treatment	1. Patients with anti-HCV and/or HCV RNA positive; 2. Patients without cirrhosis.
Cirrhosis cohort	Anti-virus treatment	1. Patients diagnosised with cirrhosis; 2. Patients with HBsAg, and/or HBV DNA, and/or anti-HCV and/or HCV RNA positive.
Liver cancer cohort	Anti-virus treatment	1. Patients diagnosised with liver cancer; 2. Patients with HBsAg, and/or HBV DNA, and/or anti-HCV and/or HCV RNA positive.

Primary Outcome Measures

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

Secondary Outcome Measures

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