Back to resultsNon-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
blood draw
Sponsored by
About this trial
This is an interventional screening trial for Chronic Hepatitis B
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02355951
Brief Title
Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Transgene
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
blood draw
Primary Outcome Measure Information:
Title
Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb)
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
City
Montréal
Country
Canada
City
Grenoble
Country
France
City
Lyon
Country
France
City
Nancy
Country
France
City
Paris
Country
France
City
Strasbourg
Country
France
City
Freiburg
Country
Germany
City
Hamburg
Country
Germany
City
Hannover
Country
Germany
City
Mainz
Country
Germany
City
München
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
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