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NCT02355951 Clinical Trial

Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection

Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02355951
Other study ID # TG1050.01
Secondary ID
Status Completed
Phase N/A
First received January 21, 2015
Last updated February 1, 2016
Start date December 2014
Est. completion date February 2016

Study information
Verified date February 2016
Source Transgene
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Other:
• blood draw

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Transgene

Countries where clinical trial is conducted

Canada,  France,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb) Day 1 No
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