An observational study in Hepatitis B， Chronic, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 6 sites in China. Per ClinicalTrials.gov, last updated 2017-03-31.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Observational
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.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 390 across 407 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients chronically infected with hepatitis B virus
Exclusion Criteria:
Number of participants with antigen loss (HBeAg and HBsAg loss)
Time frame: 20 years
Cirrhosis
Time frame: 20 years
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
Time frame: 20 years
Hepatocellular carcinoma (HCC)
The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
Time frame: 20 years
Death
Date and cause of death will be recorded.
Time frame: 20 years
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School