An observational study in Hepatitis, Chronic, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-07-19.
Sponsored by Huashan Hospital · Observational
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.
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.
Patients with chronic viral hepatitis.
Exclusion Criteria:
Serious psychiatric history, especially depression.
No intervention. The clinical data of patients (including demographic information, details of antiviral therapy, imaging and laboratory testings) will be collected and analyzed.
No intervention. The clinical data of patients (including demographic information, details of antiviral therapy, imaging and laboratory testings) will be collected and analyzed.
Virologic responses(for both chronic hepatitis B and C)
Sustained virological response （Able to sustain an undetectable viral load for a period）
Time frame: 24 weeks after treatment initiation
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)
Time frame: 48 weeks after treatment initiation
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).
Time frame: 48 weeks after treatment initiation
Plan to share: Undecided
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Huashan Hospital