NCT03097952

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jan 2008Dec 2030

Study Start

First participant enrolled

January 1, 2008

Completed
9.2 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 31, 2017

Completed
13.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

March 31, 2017

Status Verified

March 1, 2017

Enrollment Period

22.9 years

First QC Date

March 6, 2017

Last Update Submit

March 26, 2017

Conditions

Hepatitis B， Chronic

Outcome Measures

Primary Outcomes (5)

  • Number of participants with antigen loss (HBeAg and HBsAg loss)

    20 years

  • Cirrhosis

    20 years

  • Hepatic decompensation

    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)

    The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.

    20 years

  • Death

    Date and cause of death will be recorded.

    20 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients chronically infected with hepatitis B virus

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The Third Hospital of Changzhou

Changzhou, Jiangsu, 213001, China

RECRUITING

Huai'an No.4 People's Hospital

Huai'an, Jiangsu, 223300, China

RECRUITING

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Nanjing Jiangbei People's Hospital

Nanjing, Jiangsu, 210048, China

RECRUITING

Suqian People's Hospital

Suqian, Jiangsu, 223800, China

RECRUITING

The Fifth People's Hospital of Suzhou

Suzhou, Jiangsu, 215007, China

RECRUITING

Related Publications (3)

  • Wang J, Zhu L, Zhang Z, Zhang S, Pan Y, Li Y, Cao F, Jiang C, Fan T, Xiong Y, Liu J, Chen Y, Yin S, Tong X, Zhu C, Liu X, Li J, Wu C, Huang R. Lower HBV DNA level is associated with more severe liver fibrosis in HBeAg-positive chronic hepatitis B with normal alanine transaminase. Virol J. 2024 Jun 4;21(1):127. doi: 10.1186/s12985-024-02368-0.

    PMID: 38835029DERIVED

  • Yao R, Lu S, Xue R, Wang J, Qiu Y, Chen Y, Liu J, Zhu L, Zhan J, Jiang S, Yin S, Tong X, Ding W, Li J, Zhu C, Huang R, Wu C. NAFLD is associated with less severe liver fibrosis in chronic hepatitis B: A multi-center, retrospective study. Ann Hepatol. 2024 Jan-Feb;29(1):101155. doi: 10.1016/j.aohep.2023.101155. Epub 2023 Sep 24.

    PMID: 37742745DERIVED

  • Wang J, Liu J, Liu Y, Xue R, Zhan J, Jiang S, Wang L, Yan X, Xiong Y, Xia J, Yin S, Tong X, Chen Y, Li J, Huang R, Wu C. Clinical features of chronic hepatitis B patients with lean nonalcoholic fatty liver disease. Hepatol Res. 2023 Mar;53(3):184-195. doi: 10.1111/hepr.13854. Epub 2022 Nov 21.

    PMID: 36317959DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Liver biopsy tissue, blood (serum, plasma, and DNA)

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Chao Wu, M.D., Ph.D

CONTACT

86-25-83105890dr.wu@nju.edu.cn

Rui Huang, M.D., Ph.D.

CONTACT

doctor_hr@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 6, 2017

First Posted

March 31, 2017

Study Start

January 1, 2008

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

March 31, 2017

Record last verified: 2017-03

Locations

CN(6)