Hepatitis BPIBACNCT02247752
Follow-up of HBsAg Inactive Carriers Study
A study testing inactive carrier in people with Hepatitis B, run by Centre Hospitalier Régional d'Orléans at 32 sites in France.
Trial summary
The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ". This definition continue to be not totally consensual. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- inactive carrier
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 619 participants
- Where
- 32 sitesFrance
- Study dates
- 16 Sep 2014to 4 Feb 2022
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HBsAg + since one year or more.
- HBeAg -, anti-HBe antibodies +
- HBV-DNA < 20000 UI/ml on all dosages realized during past year (ultra-sensitive PCR with a detection threshold < 20 UI/ml), at least 2 dosages during past year.
- AST and ALT transaminases < ULN on all dosages realized during past year (at least 3).
- Age > 18 and < 70
- We will include consecutively all encountered patients (consultation, hospitalization) and diagnosed as HBsAg inactive carriers in each participating center.
Who cannot join
- anti-VHC antibodies +
- anti-VHD antibodies +
- anti-VIH antibodies +
- genetic hemochromatosis
- liver cirrhosis on liver biopsy or with non-invasive methods (Fibrometer, Fibroscan, Fibrotest, Hepascore …)
- Past or present treatment against HBV
- Ultrasonic diagnosis of HCC or Portal Hypertension
- non compliant patient whom 5 years follow-up seems uncertain.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
France32 sites
Ch General Du Pays D'Aix
Aix-en-Provence, 13616
CH d'AVIGNON
Avignon, 84902
Clinique de La Chataigneraie
Beaumont, 63110
Medical Center Besancon
Besançon, 25000
Clinical Center Bourgoin Jallieu
Bourgoin, 38300
Hopital Sainte Camille
Bry-sur-Marne, 94360
Ch de Caen
Caen, 14033
Ch Sud Fracilien Jean Jaures
Corbeil-Essonnes, 91100
CH CREIL
Creil, 60109
Ch de Creteil
Créteil, 94000
CH de GONESSE
Gonesse, 95503
Clinique Du Palais
Grasse, 06130
Ch D'Hyeres
Hyères, 83407
Ch de Lagny Marne La Valee
Jossigny, 77600
Chd Vendee
La Roche-sur-Yon, 85925
Ch Du Mans
Le Mans, 72037
Medical Center La Sauvegarde
Lyon, 69009
Ch de Meaux
Meaux, 77104
CH MELUN
Melun, 77011
Ch Montelimar
Montélimar, 26126
Ch de Montfermeil
Montfermeil, 93370
Clinical Center Montpellier
Montpellier, 34070
Medical Center Nanterre
Nanterre, 92000
CHR d'ORLEANS
Orléans, 45067
Medical Center Paris 7
Paris, 75007
Ch de Pau
Pau, 64000
Hopital Saint Jean
Perpignan, 66046
Ch de La Region Annnecienne
Pringy, 74374
Ch Saint Brieuc
Saint-Brieuc, 22027
Ch de Saint Denis
Saint-Denis, 93200
Ch de Vannes
Vannes, 56017
Chi Villeneauve Saint Georges
Villeneuve-Saint-Georges, 94190
About this study
The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40 UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg quantification for the prognosis of such events or, in contrary HBs seroconversion; will evaluate the influence of B genotype on HBsAg level; will evaluate the influence of comorbidities on unexpected arrival of such events.
- Conditions
- Hepatitis B
- Being tested
- inactive carrier
- Keywords
- hepatitis, HBV, chronic hepatitis, HCC, cirrhosis, quantitative HBsAg, HBsAg inactive carriers
- Medical subject headings
- Hepatitis B, Hepatitis, Hepatitis, Chronic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inactive carrierOther
Yearly demographic, clinic, biologic and ultrasonic data collection realized during usual follow-up as recommended.
Yearly centralisation of a complementary biological analysis in Paul Brousse Hospital laboratory of virology.
| Study group | Role | What they receive |
|---|---|---|
| Inactive carriers | Other | Not described Receives: Other: inactive carrier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of unfavourable liver events
The primary outcome that the study was designed to evaluate is the incidence of unfavourable liver events (chronic hepatitis B, liver cirrhosis, HCC) in a cohort of patients presumed to be " HBsAg inactive carriers ".
Measured: every year, during 5 years for each
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start16 Sep 2014
- Primary completion31 Mar 2016
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 619 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF, Faculté de mathématiques ORLEANS
- Responsible party
- Sponsor
- Investigators
- Xavier CAUSSE, Principal investigator, CHR Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247752
- Sponsor's protocol ID
- CHRO -2014-02
- Acronym
- PIBAC
- Status last verified
- Apr 2022
- First submitted
- 15 Sep 2014
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of HBsAg Inactive Carriers Study
- ClinicalTrials.gov ID
- NCT02247752
- Acronym / sponsor ID
- PIBAC / CHRO -2014-02
- Conditions
- Hepatitis B
- Keywords
- hepatitis, HBV, chronic hepatitis, HCC, cirrhosis, quantitative HBsAg, HBsAg inactive carriers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 619 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Collaborators
- INSERM U785-CNR Hôpital Paul Brousse 94800 VILLEJUIF, Faculté de mathématiques ORLEANS
- Study start
- 16 Sep 2014 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 25 Sep 2014 (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.
The definition of HBs antigen (HBsAg) inactive carrier status has evolved during time. We spoke first from HBsAg" healthy carrier ", then from " asymptomatic carrier ", last from HBsAg" inactive carrier ". This definition continue to be not totally consensual. A very low viral load (< 2000 UI/ml) or undetectable, associated with repetitive normal transaminases and with detectable anti-HBe antibodies were necessary to affirm the inactive carrier status on 2009 EASL recommendations. The 2012 EASL recommendations confirm that the normality of alanine aminotransferase (ALT) with an upper limit of normal (ULN) approximately below 40 UI/ml, like low viral load (HBV-DNA), does necessary be verified every 3 or 4 months during a year to diagnose an inactive carrier. Nevertheless, they admit the possibility for some patients to be inactive carriers with HBV-DNA between 2000 and 20000 UI/ml with consistently normal transaminases This study will follow-up HBsAg inactive carriers during 5 years, in order to evaluate the incidence of unfavourable liver events: chronic hepatits B, liver cirrhosis, hepatocarcinoma (CHC) during this time, and to determine the independant prognosis criteria of unexpected arrival of such events. Secondary outcomes will evaluate HBsAg quantification for the prognosis of such events or, in contrary HBs seroconversion; will evaluate the influence of B genotype on HBsAg level; will evaluate the influence of comorbidities on unexpected arrival of such events.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inactive carriers | Other | Other: inactive carrier |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HBsAg + since one year or more.
Key exclusion criteria (8 listed)
- anti-VHC antibodies +
- anti-VHD antibodies +
- anti-VIH antibodies +
- genetic hemochromatosis
- liver cirrhosis on liver biopsy or with non-invasive methods (Fibrometer, Fibroscan, Fibrotest, Hepascore …)
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 |
|---|---|---|
| inactive carrierYearly demographic, clinic, biologic and ultrasonic data collection realized during usual follow-up as recommended. Yearly centralisation of a complementary biological analysis in Paul Brousse Hospital laboratory of virology. | Other | Inactive carriers |
Primary outcome
Incidence of unfavourable liver events
Time frame: every year, during 5 years for each
The primary outcome that the study was designed to evaluate is the incidence of unfavourable liver events (chronic hepatitis B, liver cirrhosis, HCC) in a cohort of patients presumed to be " HBsAg inactive carriers ".
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 6 Apr 2022.
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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.
Xavier CAUSSE principal investigator
CHR Orleans
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inactive carrier in people with Hepatitis B, run by Centre Hospitalier Régional d'Orléans at 32 sites in France.
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 6 inclusion and 8 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in France. 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?
Incidence of unfavourable liver events (time frame: every year, during 5 years for each). 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 6 Apr 2022.