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NCT Number: NCT04025944

Real World Study of Chronic Viral Hepatitis

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Huashan Hospital

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Yiqi Yu, doctor

CONTACT

[email protected]

13601637563

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed consent of patients.
  • 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

  • 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.
  • Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.
  • Patients with malignant tumors (excluding those cured).

Treatment and study plan

Primary outcomes

  1. Virologic responses(for both chronic hepatitis B and C)

    Time frame: 24 weeks after treatment initiation

    Sustained virological response (Able to sustain an undetectable viral load for a period)

  2. Serological responses(for chronic hepatitis B only)

    Time frame: 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 outcomes

  1. Histological responses(for both chronic hepatitis B and C)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Yiqi Yu, Doctor

CONTACT

[email protected]

13601637563 ext. 02152887969

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2029
First posted
Jul 19, 2019
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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