Real World Study of Chronic Viral Hepatitis

Recruiting

• Conditions: Hepatitis, Chronic

• Registration Number: NCT04025944
• Lead Sponsor: Huashan Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-07
• Study First Submitted QC: 2019-07-18
• Last Update Submitted: 2019-07-18
• Study First Posted: 2019-07-19
• Last Update Posted: 2019-07-19
• Study Start: 2019-07-20
• Primary Completion: 2024-08-01
• Study Completion: 2029-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Virologic responses(for both chronic hepatitis B and C)	24 weeks after treatment initiation	Sustained virological response （Able to sustain an undetectable viral load for a period）
Serological responses(for chronic hepatitis B only)	48 weeks after treatment initiation	Hepatitis B e antigen (HBeAg) seroconversion(HBeAg loss and presence of anti-HBe) and hepatitis B surface antigen(HBsAg) seroconversion (HBsAg loss and presence of anti-HBs)

Secondary Outcome Measures

Name	Time	Method
Histological responses(for both chronic hepatitis B and C)	48 weeks after treatment initiation	Significant improvement in fibrosis was defined as a decrease in the Ishak score of at least 1 point; (the Ishak score describes six stages of fibrosis, 0 for No fibrosis and 6 for Cirrhosis; higher the Ishak score is, more severe the fibrosis is).

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China