Real World Study of Chronic Viral Hepatitis

NCT ID: NCT04025944

Last Updated: 2019-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-20

Study Completion Date

2029-08-01

Brief Summary

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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

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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.

Conditions

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Hepatitis, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-hong Zhang

Chief of department of infectious disease

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wenhong Zhang, Professor

Role: STUDY_CHAIR

Huashan Hospital

Locations

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Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yiqi Yu, Doctor

Role: CONTACT

13601637563 ext. 02152887969

Facility Contacts

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Yiqi Yu, doctor

Role: primary

13601637563

References

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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.

Reference Type BACKGROUND
PMID: 29388206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29599078 (View on PubMed)

Other Identifiers

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KY2019-RWS(CVH)

Identifier Type: -

Identifier Source: org_study_id

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