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
• 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

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

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