Chronic Hepatitis BNCT02355951
Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
A study testing blood draw in people with Chronic Hepatitis B, run by Transgene at 11 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- blood draw
- How many people
- 166 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Dec 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
France5 sites
Study site
Grenoble
Study site
Lyon
Study site
Nancy
Study site
Paris
Study site
Strasbourg
Germany5 sites
Study site
Freiburg im Breisgau
Study site
Hamburg
Study site
Hanover
Study site
Mainz
Study site
München
About this study
Objectives:
Primary Objective:
Read more
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
- Chronic Hepatitis B
- Being tested
- blood draw
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355951
- Sponsor's protocol ID
- TG1050.01
- Status last verified
- Feb 2016
- First submitted
- 21 Jan 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection
- ClinicalTrials.gov ID
- NCT02355951
- Acronym / sponsor ID
- TG1050.01
- Conditions
- Chronic Hepatitis B
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- TransgeneIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood draw | Other | – |
Primary outcome
Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood draw in people with Chronic Hepatitis B, run by Transgene at 11 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016.