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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|ClinicalTrials.gov Identifier: NCT02355951|
Recruitment Status : Completed
First Posted : February 4, 2015
Last Update Posted : February 2, 2016
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.
To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B||Other: blood draw||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
- Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb) [ Time Frame: Day 1 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355951