Chronic Hepatitis B
Conditions
Brief summary
Objectives: Primary Objective: To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b First in Man (FIM) study. Secondary Objectives: To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients. Methodology: Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a central laboratory using a newly validated assay.
Interventions
OTHERblood draw
Sponsors
Transgene
Study design
Primary purpose
SCREENING
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18 through 65 years of age, inclusive * Patients mono-infected with HBV and currently on HBV treatment for at least 2 years with either the nucleos(t)ide tenofovir (TDF) or entecavir (ENT) * HBV DNA \< lower limit of quantification (LLOQ) (eg, HBV deoxyribonucleic acid (DNA) \< 20 IU/mL using the Roche COBAS TaqMan assay) within 6 last months * Signed, written Independent Ethics Committee (IEC)-approved informed consent
Exclusion criteria
* Patients with either medical history or evidence of cirrhosis, as documented in the medical source, who had: a) any biopsy showing cirrhosis; or b) any transient elastography score of ≥ 10.5 kPa or Fibrosure® / FibroTest ® score of ≥ 0.48 with either test result within past 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb) | Day 1 |
Countries
Canada, France, Germany
Outcome results
None listed