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Trial record 122 of 306 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
Verified March 2017 by Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor:
ClinicalTrials.gov Identifier:
NCT03097952
First Posted: March 31, 2017
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  Purpose
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.

Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: "Real-life" Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu

Resource links provided by NLM:


Further study details as provided by Chao Wu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School:

Primary Outcome Measures:
  • Number of participants with antigen loss (HBeAg and HBsAg loss) [ Time Frame: 20 years ]
  • Cirrhosis [ Time Frame: 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


  • 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.

  • Death [ Time Frame: 20 years ]
    Date and cause of death will be recorded.


Biospecimen Retention:   Samples With DNA
Liver biopsy tissue, blood (serum, plasma, and DNA)

Estimated Enrollment: 20000
Study Start Date: January 2008
Estimated Study Completion Date: December 2030
Estimated Primary Completion Date: December 2030 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients chronically infected with hepatitis B virus
Criteria

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)
  Contacts and Locations
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): NCT03097952


Contacts
Contact: Chao Wu, M.D., Ph.D 86-25-83105890 dr.wu@nju.edu.cn
Contact: Rui Huang, M.D., Ph.D. doctor_hr@126.com

Locations
China, Jiangsu
The Third Hospital of Changzhou Recruiting
Changzhou, Jiangsu, China, 213001
Contact: Longgen Liu         
Huai'an No.4 People's Hospital Recruiting
Huai'an, Jiangsu, China, 223300
Contact: Biao Zhang         
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Chao Wu, M.D., Ph.D.    86-25-83105890    dr.wu@nju.edu.cn   
Contact: Rui Huang, M.D., Ph.D.       doctor_hr@126.com   
Nanjing Jiangbei People's Hospital Recruiting
Nanjing, Jiangsu, China, 210048
Contact: Jie Yin         
Suqian People's Hospital Recruiting
Suqian, Jiangsu, China, 223800
Contact: Huaping Shao         
The Fifth People's Hospital of Suzhou Recruiting
Suzhou, Jiangsu, China, 215007
Contact: Chuanwu Zhu         
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
  More Information

Responsible Party: Chao Wu, Prof., The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier: NCT03097952     History of Changes
Other Study ID Numbers: NJDTID-001
First Submitted: March 6, 2017
First Posted: March 31, 2017
Last Update Posted: March 31, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic