Real World Study of Chronic Viral Hepatitis

NCT04025944 | Recruiting DMC

• 1 other identifier: KY2019-RWS(CVH)
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis, Chronic

Outcome Measures

Primary Outcomes (2)

• Virologic responses(for both chronic hepatitis B and C)

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

  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)

  48 weeks after treatment initiation

Secondary Outcomes (1)

• Histological responses(for both chronic hepatitis B and C)

  48 weeks after treatment initiation

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic viral hepatitis.

You may qualify if:

• Informed consent of patients.
• Evidence of persistent virus infection for greater than six months \[hepatitis C virus(HCV) RNA positive, hepatitis B surface antigen(HBsAg) or hepatitis B virus(HBV) DNA positive\]

You may not qualify if:

• 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).

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 29388206 BACKGROUND

• 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.

  PMID: 29599078 BACKGROUND

MeSH Terms

Conditions

Hepatitis, Chronic

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenhong Zhang, Professor

  Huashan Hospital

  STUDY CHAIR

Central Study Contacts

Yiqi Yu, Doctor

CONTACT

13601637563; yyq19890619@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of department of infectious disease

Study Record Dates

• First Submitted: July 7, 2019
• First Posted: July 19, 2019
• Study Start: July 20, 2019
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

CN (1)