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

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.

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Key information

Conditions

Hepatitis B， Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Hospital of Changzhou, Changzhou, Jiangsu, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Number of participants with antigen loss (HBeAg and HBsAg loss)

Time frame: 20 years
Cirrhosis

Time frame: 20 years
Hepatic decompensation

Time frame: 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
Hepatocellular carcinoma (HCC)

Time frame: 20 years

The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
Death

Time frame: 20 years

Date and cause of death will be recorded.

Study contacts

Contact information is provided by the study sponsor or research team.

Chao Wu, M.D., Ph.D

CONTACT

[email protected]

86-25-83105890

Rui Huang, M.D., Ph.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2030
Study completion: 2030
First posted: Mar 31, 2017
Registry last updated: Mar 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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