"Real-life" Cohort Study on Patients With Chronic HBV Infection in Jiangsu

Hepatitis B, Chronic Clinical Trial

Official title:

"Real-life" Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03097952
• Other study ID #: NJDTID-001
• Status: Recruiting
• Phase: N/A
• First received: March 6, 2017
• Last updated: March 26, 2017
• Start date: January 2008
• Est. completion date: December 2030

Study information

• Verified date: March 2017
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Chao Wu, M.D., Ph.D
• Phone: 86-25-83105890
• Email: dr.wu[@]nju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the outcome of chronic HBV infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic HBV infection are still needed. The investigators purpose is to constitute a observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 2030
• Est. primary completion date: December 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)

Exclusion Criteria:

• Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)

• History of liver transplantation

• History of hepatocellular carcinoma (HCC)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Locations

Country	Name	City	State
China	The Third Hospital of Changzhou	Changzhou	Jiangsu
China	Huai'an No.4 People's Hospital	Huai'an	Jiangsu
China	Nanjing Jiangbei People's Hospital	Nanjing	Jiangsu
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Suqian People's Hospital	Suqian	Jiangsu
China	The Fifth People's Hospital of Suzhou	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with antigen loss (HBeAg and HBsAg loss)		20 years
Primary	Cirrhosis		20 years
Primary	Hepatic decompensation	Development of hepatic decompensation will be defined by any of the following events: (1) Ascites or hepatic hydrothorax; (2)Variceal or portal hypertensive bleeding; (3)Hepatic encephalopathy	20 years
Primary	Hepatocellular carcinoma (HCC)	The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.	20 years
Primary	Death	Date and cause of death will be recorded.	20 years