Trials / Completed
CompletedNCT02355951
Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 166 (actual)
- Sponsor
- Transgene · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | blood draw |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2016-02-01
- Completion
- 2016-02-01
- First posted
- 2015-02-04
- Last updated
- 2016-02-02
Locations
11 sites across 3 countries: Canada, France, Germany
Source: ClinicalTrials.gov record NCT02355951. Inclusion in this directory is not an endorsement.