NCT02355951

Completed

Non-investigational Study to Evaluate Adenovirus Serotype 5 ...

Transgene Source

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Other study identifiers

Sponsor study identifier

TG1050.01

Study Type

interventional

Actual enrollment (reported)

166

Locations

3 countries

Sites

11

Timeline

Study Start

December 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2016

Actual (reported)

Study Completion

February 2016

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 166 participants
Study completion date: February 2016
Actual (reported)
Listed locations: 3 countries · 11 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
December 2014
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 21, 2015
Actual (reported)
First Posted
February 4, 2015
Actual (reported)
Primary Completion
February 2016
Actual (reported)
Study Completion
February 2016
Actual (reported)

Last Updated: February 2, 2016
Status Verified: February 2016
Last Update Submitted: February 1, 2016

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb)
Day 1

Interventions

blood drawOther

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

Transgene
Industrylead

Study Sites (11)

Montreal, Canada

Grenoble, France

Lyon, France

Nancy, France

Paris, France

Strasbourg, France

Freiburg im Breisgau, Germany

Hamburg, Germany

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System Diseases

Enrollment

166 participants (actual enrollment reported by the registry).

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 2014

Date type not reported

This date has not been verified as actual or estimated.

NCT02581033

Determinants of Virological Response After Discontinuation of Nucleoside Analogue Therapy in Hepatitis B Patients

Not ApplicableUnknown

NCT02738554

Off Treatment Durability in Chronic Hepatitis B With Good Immune Control

Not ApplicableCompleted

NCT01813487

Study of the Immunogenicity and Efficacy of HBsAg Vaccine in Combination With Standard Antiviral Therapy With HB110E

Not ApplicableCompleted

NCT03018821

The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B

Not ApplicableUnknown

NCT02605252

New Strategy Study of Functional Cure of Chronic Hepatitis B

Not ApplicableUnknown

NCT02899130

Effect of Polyherbal Formulation in Chronic Inactive Carriers of Hepatitis B Virus

Not ApplicableUnknown

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.

Hanover, Germany

Mainz, Germany

München, Germany

Chronic Disease

Disease Attributes

Pathologic Processes

Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Primary Completion

February 2016

Actual (reported)

Study Completion

February 2016

Actual (reported)

Last Updated

February 2, 2016

Record last verified: 2016-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02355951
Data provider: ClinicalTrials.gov
Source updated: 2016-02-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:23 UTC

Locations

CA(1)DE(5)FR(5)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations