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T-cell Dysfunction in Chronic HBV Infection

NCT05099458 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-10-29

No results posted yet for this study

Summary

Chronic hepatitis B (CHB) infection remains an important public health with more than 240 million people chronically infected despite the existence of an effective vaccine. Cirrhosis and hepatocellular carcinoma (HCC) are major complications of CHB infection and are responsible for more than 600,000 deaths each year. These complications are strongly related to the function of the immune system. Indeed, the persistence of HBV and the progression of liver disease are mainly due to the development of an ineffective immune response to HBV. Therefore, the clinical outcome depends on the complex interaction between HBV replication and adaptive immune responses.

The ultimate goal of antiviral treatments is the elimination of HBsAgHBs and the appearance of anti-HBs antibodies without detectable PCR replication. Current treatments are effective at lowering viral DNA levels, but they are not able to permanently eliminate chronic HBV infection, due to the persistence of cDNA in the nucleus of infected hepatocytes. This therapeutic goal is rarely achieved and new therapeutic approaches are needed. In this sense, Immunotherapy represents a very promising new therapeutic approach that could lead to the cure of chronic HBV infection. Indeed, HBV infection is characterized by a progressive depletion of T lymphocytes which results in a progressive loss of function, associated with a sustained positive regulation of inhibitory control molecules.

Thus, the objective of this study is to define the immune signature and the main control pathways associated with T-cell depletion in patients chronically infected with HBV, by analyzing immune cells isolated from these patients at phenotypic , transcriptional and functional levels

Conditions

  • Chronic Hepatitis B Virus

Interventions

BIOLOGICAL

Additional blood sampling (100 ml)

only an additional blood volume will be collected at the same time of the standard blood collection for these patients

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • François HABERSETZER, MD · University Hospital, Strasbourg, France

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2022-04-25
Completion
2022-04-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05099458 on ClinicalTrials.gov