Real World Study of Chronic Viral Hepatitis

Fudan University

Status: Enrolling

Conditions: Hepatitis, Chronic

Study type: Observational

Funder types: Other

Identifiers

NCT04025944

KY2019-RWS(CVH)

Details and patient eligibility

About

This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data.

Full description

Chronic viral hepatitis is defined as infectious liver disease caused by persistent virus infection for more than six months. Sustained viral replication and ongoing liver inflammation can eventually lead to liver fibrosis/cirrhosis or even hepatocellular carcinoma. Chronic viral hepatitis infection causes at least 80% of all liver cancers.

Though chronic viral hepatitis is a major global health concern, there is still a lack of evidence in high quality about the management of chronic viral hepatitis and the long-term outcome of patients. The concept of real-world data and research has been officially introduced into China since 2010. Real-world evidence, based on real-world data, can help practitioners have better understanding of the characteristics of the patients with different treatment strategies.

This study is aimed to collect and analyze clinical data of patients with chronic viral hepatitis in the real world, to investigate the long-term outcome of these patients and to optimize treatment options based on these data.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed consent of patients.
2. Evidence of persistent virus infection for greater than six months [hepatitis C virus(HCV) RNA positive, hepatitis B surface antigen(HBsAg) or hepatitis B virus(HBV) DNA positive]

Exclusion criteria

1. Serious psychiatric history, especially depression.

   • Severe mental illness is defined as major depression or psychosis, suicide attempts, hospitalization due to mental illness or a period of disability due to mental illness.

2. Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.

3. Patients with malignant tumors (excluding those cured).

Trial design

10,000 participants in 2 patient groups

chronic hepatitis B

Description:

No intervention. The clinical data of patients (including demographic information, details of antiviral therapy, imaging and laboratory testings) will be collected and analyzed.

chronic hepatitis C

Description:

No intervention. The clinical data of patients (including demographic information, details of antiviral therapy, imaging and laboratory testings) will be collected and analyzed.