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Real World Study of Chronic Viral Hepatitis

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ClinicalTrials.gov Identifier: NCT04025944
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Wen-hong Zhang, 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.

Condition or disease
Hepatitis, Chronic

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Real World Study of Chronic Viral Hepatitis
Estimated Study Start Date : July 20, 2019
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : August 1, 2029

Resource links provided by the National Library of Medicine


Group/Cohort
chronic hepatitis B
No intervention. The clinical data of patients (including demographic information, details of antiviral therapy, imaging and laboratory testings) will be collected and analyzed.
chronic hepatitis C
No intervention. The clinical data of patients (including demographic information, details of antiviral therapy, imaging and laboratory testings) will be collected and analyzed.



Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic viral hepatitis.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025944


Contacts
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Contact: Yiqi Yu, Doctor 13601637563 ext 02152887969 yyq19890619@126.com

Locations
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China, Shanghai
Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200000
Contact: Yiqi Yu, doctor    13601637563    yyq19890619@126.com   
Sponsors and Collaborators
Huashan Hospital
Investigators
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Study Chair: Wenhong Zhang, Professor Huashan Hospital
Publications:
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Responsible Party: Wen-hong Zhang, Chief of department of infectious disease, Huashan Hospital
ClinicalTrials.gov Identifier: NCT04025944    
Other Study ID Numbers: KY2019-RWS(CVH)
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections