Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
1 other identifier
interventional
166
3 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
11 active sites
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
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 2, 2016
February 1, 2016
1.2 years
January 21, 2015
February 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb)
Day 1
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Transgenelead
Study Sites (11)
Unknown Facility
Montreal, Canada
Unknown Facility
Grenoble, France
Unknown Facility
Lyon, France
Unknown Facility
Nancy, France
Unknown Facility
Paris, France
Unknown Facility
Strasbourg, France
Unknown Facility
Freiburg im Breisgau, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Mainz, Germany
Unknown Facility
München, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- SCREENING
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2015
First Posted
February 4, 2015
Study Start
December 1, 2014
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
February 2, 2016
Record last verified: 2016-02