Clinical Trial on Hepatitis, Chronic - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yiqi Yu, Doctor
Phone Number: 02152887969 13601637563
Email: yyq19890619@126.com

Study Locations

China
- Shanghai
  - Shanghai, Shanghai, China, 200000
    - Recruiting
    - Huashan Hospital
    - Contact:
      
      Yiqi Yu, doctor
      
      Phone Number: 13601637563
      
      Email: yyq19890619@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic viral hepatitis.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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）	24 weeks after treatment initiation
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)	48 weeks after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	48 weeks after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

Study Chair: Wenhong Zhang, Professor, Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 20, 2019

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

August 1, 2029

Study Registration Dates

First Submitted

July 7, 2019

First Submitted That Met QC Criteria

July 18, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)