Clinical trial NCT04025944: Real World Study of Chronic Viral Hepatitis
Official title: Real World Study of Chronic Viral Hepatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis, Chronic
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2019-07-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic viral hepatitis.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Virologic responses(for both chronic hepatitis B and C)
timeFrame: 24 weeks after treatment initiation
measure: Serological responses(for chronic hepatitis B only)
timeFrame: 48 weeks after treatment initiation
Secondary outcomes:
measure: Histological responses(for both chronic hepatitis B and C)
timeFrame: 48 weeks after treatment initiation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Wenhong Zhang, Professor
role: STUDY_CHAIR
References:
citation: 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.
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.