"Real-life" Cohort Study on Patients With Chronic HBV Infection in Jiangsu

March 26, 2017 updated by: Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

"Real-life" Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu

Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the outcome of chronic HBV infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic HBV infection are still needed. The investigators purpose is to constitute a observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

20000

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: Chao Wu, M.D., Ph.D
  • Phone Number: 86-25-83105890
  • Email: dr.wu@nju.edu.cn

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213001
        • Recruiting
        • The Third Hospital of Changzhou
        • Contact:
          • Longgen Liu
      • Huai'an, Jiangsu, China, 223300
        • Recruiting
        • Huai'an No.4 People's Hospital
        • Contact:
          • Biao Zhang
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
        • Contact:
        • Contact:
      • Nanjing, Jiangsu, China, 210048
        • Recruiting
        • Nanjing Jiangbei People's Hospital
        • Contact:
          • Jie Yin
      • Suqian, Jiangsu, China, 223800
        • Recruiting
        • Suqian People's Hospital
        • Contact:
          • Huaping Shao
      • Suzhou, Jiangsu, China, 215007
        • Recruiting
        • The Fifth People's Hospital of Suzhou
        • Contact:
          • Chuanwu Zhu

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients chronically infected with hepatitis B virus

Description

Inclusion Criteria:

  • Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)

Exclusion Criteria:

  • Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)
  • History of liver transplantation
  • History of hepatocellular carcinoma (HCC)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with antigen loss (HBeAg and HBsAg loss)
Time Frame: 20 years
20 years
Cirrhosis
Time Frame: 20 years
20 years
Hepatic decompensation
Time Frame: 20 years

Development of hepatic decompensation will be defined by any of the following events:

(1) Ascites or hepatic hydrothorax; (2)Variceal or portal hypertensive bleeding; (3)Hepatic encephalopathy
20 years
Hepatocellular carcinoma (HCC)
Time Frame: 20 years
The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
20 years
Death
Time Frame: 20 years
Date and cause of death will be recorded.
20 years

Collaborators and Investigators

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

January 1, 2008

Primary Completion (Anticipated)

December 1, 2030

Study Completion (Anticipated)

December 1, 2030

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

March 26, 2017

First Posted (Actual)

March 31, 2017

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 26, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJDTID-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B， Chronic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe