An observational study in Hepatitis B, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-29.
Sponsored by Hospices Civils de Lyon · Observational
Activation of the immune system against a pathogen can be considered one of the most effective interventions in the field of infectious diseases.
Transgene is developing a therapeutic vaccine "TG1050" for the treatment of patients with chronic and treated Hepatitis B. This biotherapy compound is for the development of T cellular immune response in these patients in order to achieve the total elimination of infected cells.
Therefore it is necessary to have measures of ways to assess accurately and reliably the presence of such a response in the study subjects.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 34 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Hepatitis B infected patients or cured
Man or woman aged ≥18 years old.
Patients with chronic hepatitis B regardless of the genotype.
Patients with a history of HBV infection (recovered) with seroconversion of antigen HBs spontaneously or under treatment.
Patient with a general state ranging 0 or 1 on the ECOG scale (Eastern Cooperative Oncology Group)
Patient who signed the informed consent
Patient with a social security affiliation
Exclusion Criteria:
patients co-infected with human immunodeficiency virus (HIV) or Hepatitis C virus (HCV).
Patients treated with interferon, immunosuppressive, or experimental treatment consisting of an unapproved molecule for the treatment of hepatitis B.
Patient unable to meet the constraints of the study
Patient transplanted
Patient with a history of cancer or autoimmune disease within 5 years
Pregnant or lactating women
blood samples are performed to measure active T cellular immune response during a routine visit
Biological: blood samples are performed to measure active T cellular immune response during a routine visit
During the visit 1 (V1), after signing the informed consent, 40 mL blood sampling are carried out and analyzed with the test ELISPOT to check if the patient shows a T immune response against HBV. The visit 2 will be performed 4-8 weeks (depending on the availability of the patient) following V1 visit, in case the patient shows an immune response against HBV positive T following the sample taken at V1. 150 ml blood sampling are carried out at this visit.
Measurement of T cell response by hepatitis B antigen detected in at least one subject.
The method is based on the ELISPOT test. The method measures the cytokine secretion associated with immune activation after stimulation of peripheral blood mononuclear cells
Time frame: at day 1
The probability of detection of a positive T cell response in a single measurement
Time frame: at day 1
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Hospices Civils de Lyon