NCT01732081

Brief Summary

It is estimated that 350-400 million people worldwide are chronically infected with hepatitis B virus (HBV). Cirrhosis and hepatocellular carcinoma are major complications of chronic HBV infection and are responsible of about 500,000 deaths each year. Although some predictive factors of the outcome of chronic HBV infection were reported, it remains needed to more precisely determine the factors which are associated with the outcome in non-selected patients. Indeed, these factors should help to identify patients who are likely to have a better or worse evolution of their chronic HBV infection over time and thus, to adapt their clinical management and monitoring.Therefore, our purpose is to constitute a "real-life" cohort of non-selected patients to create a database of epidemiological, clinical, biological, virological and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

Enrollment Period

10 years

First QC Date

November 16, 2012

Last Update Submit

November 16, 2012

Conditions

Keywords

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • to determine factors associated with the outcome of chronic HBV infection

    10 years

Study Arms (1)

Patients with chronic hepatitis B virus infection

Patients chronically infected with hepatitis B virus (HBV), and followed in university hospital of Strasbourg, France

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 (HBV), and followed in university hospital of Strasbourg, France

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)
  • Decompensated cirrhosis
  • History of liver transplantation
  • History of hepatocellular carcinoma (HCC)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2012

First Posted

November 22, 2012

Study Start

January 1, 2011

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

November 22, 2012

Record last verified: 2012-11

Locations