Real World Study of Chronic Viral Hepatitis

Hepatitis, Chronic Clinical Trial

Official title:

Real World Study of Chronic Viral Hepatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04025944
• Other study ID #: KY2019-RWS(CVH)
• Status: Recruiting
• Start date: July 20, 2019
• Est. completion date: August 1, 2029

Study information

• Verified date: July 2019
• Source: Huashan Hospital
• Contact: Yiqi Yu, Doctor
• Phone: 13601637563
• Email: yyq19890619[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: August 1, 2029
• Est. primary completion date: August 1, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis, Chronic

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Maucort-Boulch D, de Martel C, Franceschi S, Plummer M. Fraction and incidence of liver cancer attributable to hepatitis B and C viruses worldwide. Int J Cancer. 2018 Jun 15;142(12):2471-2477. doi: 10.1002/ijc.31280. Epub 2018 Feb 9. — View Citation

Polaris Observatory Collaborators. Global prevalence, treatment, and prevention of hepatitis B virus infection in 2016: a modelling study. Lancet Gastroenterol Hepatol. 2018 Jun;3(6):383-403. doi: 10.1016/S2468-1253(18)30056-6. Epub 2018 Mar 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Virologic responses(for both chronic hepatitis B and C)	Sustained virological response (Able to sustain an undetectable viral load for a period)	24 weeks after treatment initiation
Primary	Serological responses(for chronic hepatitis B only)	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)	48 weeks after treatment initiation
Secondary	Histological responses(for both chronic hepatitis B and C)	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).	48 weeks after treatment initiation