NCT02909023

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 29, 2016

Status Verified

September 1, 2016

Enrollment Period

2 months

First QC Date

September 19, 2016

Last Update Submit

December 28, 2016

Conditions

Hepatitis B

Keywords

Hepatitis B VirusElispot testT cellular immune response

Outcome Measures

Primary Outcomes (1)

  • 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

    at day 1

Secondary Outcomes (1)

  • The probability of detection of a positive T cell response in a single measurement

    at day 1

Study Arms (1)

Hepatitis B infected patients or cured

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

Interventions

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.

Hepatitis B infected patients or cured

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hepatitis B infected patients or cured

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fabien Zoulim, PU PH

    Hôpital de la Croix-Rousse

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 19, 2016

First Posted

September 21, 2016

Study Start

July 1, 2016

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

December 29, 2016

Record last verified: 2016-09

Locations

FR(1)