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

Recruiting

• Conditions: Hepatitis B， Chronic

• Registration Number: NCT03097952
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-26
• Last Update Submitted: 2017-03-26
• Study First Posted: 2017-03-31
• Last Update Posted: 2017-03-31
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hepatic decompensation	20 years	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
Number of participants with antigen loss (HBeAg and HBsAg loss)	20 years
Cirrhosis	20 years
Hepatocellular carcinoma (HCC)	20 years	The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
Death	20 years	Date and cause of death will be recorded.

Trial Locations

Locations (6)

The Third Hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China

Huai'an No.4 People's Hospital; 🇨🇳 Huai'an, Jiangsu, China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China

Nanjing Jiangbei People's Hospital; 🇨🇳 Nanjing, Jiangsu, China

Suqian People's Hospital; 🇨🇳 Suqian, Jiangsu, China

The Fifth People's Hospital of Suzhou; 🇨🇳 Suzhou, Jiangsu, China