Hepatitis BNCT02909023
Performance of the HBV ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured
An observational study of Hepatitis B, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- blood samples are performed to measure active T cellular immune response during a routine visit
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2016to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatitis B infected patients or cured
Who may be able to join
- Man or woman aged ≥18 years old.
- Patients with chronic hepatitis B regardless of the genotype.
- treated with nucleotide analogs approved for the treatment of hepatitis B.
- or untreated.
- with a positive or negative antigen HBe
- regardless of the level of transaminases.
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance of the Hepatitis B Virus (HBV) ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured
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.
- Conditions
- Hepatitis B
- Being tested
- blood samples are performed to measure active T cellular immune response during a routine visit
- Keywords
- Hepatitis B Virus, Elispot test, T cellular immune response
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samples are performed to measure active T cellular immune response during a routine visitBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B infected patients or cured | blood samples are performed to measure active T cellular immune response during a routine visit Receives: Biological: blood samples are performed to measure active T cellular immune response during a routine visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at day 1
Secondary outcomes (1)
The probability of detection of a positive T cell response in a single measurement
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabien Zoulim, PU PH, Principal investigator, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909023
- Sponsor's protocol ID
- 69HCL15_0679
- Status last verified
- Sep 2016
- First submitted
- 19 Sep 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Hepatitis B Virus (HBV) ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured
- ClinicalTrials.gov ID
- NCT02909023
- Acronym / sponsor ID
- 69HCL15_0679
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B Virus, Elispot test, T cellular immune response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B infected patients or cured | – | Biological: blood samples are performed to measure active T cellular immune response during a routine visitblood samples are performed to measure active T cellular immune response during a routine visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatitis B infected patients or cured
Key inclusion criteria (10 listed)
- Man or woman aged ≥18 years old.
- Patients with chronic hepatitis B regardless of the genotype.
- treated with nucleotide analogs approved for the treatment of hepatitis B.
- or untreated.
- with a positive or negative antigen HBe
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples are performed to measure active T cellular immune response during a routine visitDuring 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. | Biological | Hepatitis B infected patients or cured |
Primary outcome
Measurement of T cell response by hepatitis B antigen detected in at least one subject.
Time frame: at day 1
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
1 secondary outcome
The probability of detection of a positive T cell response in a single measurement
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabien Zoulim, PU PH principal investigator
Hôpital de la Croix-Rousse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of T cell response by hepatitis B antigen detected in at least one subject. (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.