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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05102838
Collaborator
(none)
60,000
52.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Anti-virus 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 Design

Study Type:
Observational
Anticipated Enrollment :
60000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Cohort Study on Prognosis of Patients With Hepatitis B/C in Hainan Province Danzhou City
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Aug 30, 2025
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Hepatitis B cohort

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

Other: Anti-virus treatment
Anti-virus treatment

Hepatitis C cohort

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

Other: Anti-virus treatment
Anti-virus treatment

Cirrhosis cohort

Patients diagnosised with cirrhosis; 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

Patients diagnosised with liver cancer; Patients with HBsAg, and/or HBV DNA, and/or anti-HCV and/or HCV RNA positive.

Other: Anti-virus treatment
Anti-virus treatment

Outcome Measures

Primary Outcome Measures

  1. Epidemiological characteristics of hepatitis B and C [up to 192 weeks]

    Epidemiological characteristics of hepatitis B and C in Danzhou City, Hainan Province

  2. Long-term outcome [up to 192 weeks]

    Long-term outcome of HBV/HCV infected patients in Danzhou City, Hainan Province

  3. Risk factors [up to 192 weeks]

    Risk factors for long-term outcome of HBV/HCV infected patients in Danzhou City, Hainan Province

Secondary Outcome Measures

  1. Incidence of cirrhosis [up to 192 weeks]

    Incidence of cirrhosis for HBV/HCV infected patients in Danzhou City, Hainan Province

  2. Incidence of liver cancer [up to 192 weeks]

    ncidence of liver cirrhosis for HBV/HCV infected patients in Danzhou City, Hainan Province

  3. Hepatic decompensation [up to 192 weeks]

    Hepatic decompensation rate for HBV/HCV infected patients in Danzhou City, Hainan Province

  4. Survival rate for liver cancer [up to 192 weeks]

    Survival rate for liver cancer patients in Danzhou City, Hainan Province

  5. Survival rate for cirrhosis [up to 192 weeks]

    Survival rate for cirrhosis patients in Danzhou City, Hainan Province

  6. HBV interruption rate of perinatal transmission [up to 192 weeks]

    HBV interruption rate of perinatal transmission in Danzhou City, Hainan Province

  7. HBsAg loss [up to 192 weeks]

    The HBsAg loss rate of HBV infected patients in Danzhou City, Hainan Province

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • HBsAg/HBV DNA positive

  • or anti-HCV/HCV RNA positive

Exclusion Criteria:
  • patients who refused to participate in the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sun Yat-sen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Lin Bingliang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT05102838
Other Study ID Numbers:
  • Spark Srudy
First Posted:
Nov 2, 2021
Last Update Posted:
Nov 2, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 2, 2021