Hepatitis B VirusHEPATITEBNCT03625258
Mutations of the Pre-core Region of Hepatite B Virus (HBV)
An observational study of Hepatitis B Virus, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Hepatitis B virus (HBV) infection constitutes a major public health threat worldwide. A total of 92 patients with HBeAg-negative chronic hepatitis B infection were recruited at Amiens University Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B Virus
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2009to 1 Feb 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: the study will be carried out from the blood samples following consultations Hepatogastroenterology in the clinical follow-up of patients chronically infected with HBV. Blood samples are stored in the Virology laboratory as part of legislation on the conservation of samples during Virology analyzes.
Who may be able to join
- Patients included will be chronic carriers (HBsAg + for more than 6 months) of HBV, with detectable serum viral load greater than or equal to 100 IU / mL, included in the queue followed by Drs. Dominique Capron and Eric N'Guyen-Khac.
- These patients will not be on anti-HBV treatment.
Who cannot join
- Patients under 18 years old
- Patients with their hepatitis B
- Patients with HBV viral load undetectable or less than 100 IU / mL.
- Immunosuppressive treatments such as corticosteroids or other
- The co-infection with the hepatitis C and / or HIV virus
- Patients with cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Mutations in the Pre-core Region of Heptatis B Virus (HBV) and Its Promoter on Serum VHB Viral Load in Chronically Infected Patients
Hepatitis B virus (HBV) infection constitutes a major public health threat worldwide. A total of 92 patients with HBeAg-negative chronic hepatitis B infection were recruited at Amiens University Hospital. The diagnostic workup included a physical examination.In conclusion, the study results confirmed that the HBV DNA level is associated with liver fibrosis status and that HBV viral load is strongly correlated with BCP and PC mutations, and it demonstrated that the impaired base pairing 1858-1896 mutations at the base of the bulge in the e encapsidation signal is independently associated with high serum HBV DNA levels.
Read the detailed description
The progression of liver disease in hepatitis B virus (HBV) infection is fostered by active virus replication. Mutations in the basal core promoter (BCP) and precore (PC) regions of the HBV genome are known to have an impact on viral replication. The aim of the present study was to assess the correlation of mutation profiles in the BCP and PC regions with the viral load in HBeAgnegative chronically infected patients. The HBV genotype, BCP/PC mutations, serum HBV DNA levels, and associated serological markers were analyzed in 92 HBeAgnegative chronically infected patients.
- Conditions
- Hepatitis B Virus
- Keywords
- mutations, infected patients
- Medical subject headings
- Hepatitis B
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotype of HBV for which the HBV viral load is a function of pre-core mutations
The main objective of the study is toevaluate a genotype of HBV for which the HBV viral load is a function of pre-core mutations in chronically infected patients.The HBV markers (including HBsAg, HBeAg and anti- HBe) were measured with chemiluminescent microparticle immunoassays running on an Architect system.
Measured: 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start1 Jan 2009
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B VirusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandrine Castelain, PU-PH, Principal investigator, CHU Amiens-Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03625258
- Sponsor's protocol ID
- AOL09-DR-CASTELAIN
- Acronym
- HEPATITEB
- Status last verified
- Jun 2026
- First submitted
- 2 Aug 2018
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Mutations in the Pre-core Region of Heptatis B Virus (HBV) and Its Promoter on Serum VHB Viral Load in Chronically Infected Patients
- ClinicalTrials.gov ID
- NCT03625258
- Acronym / sponsor ID
- HEPATITEB / AOL09-DR-CASTELAIN
- Conditions
- Hepatitis B Virus
- Keywords
- mutations, infected patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 10 Aug 2018 (actual)
- 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.
Hepatitis B virus (HBV) infection constitutes a major public health threat worldwide. A total of 92 patients with HBeAg-negative chronic hepatitis B infection were recruited at Amiens University Hospital. The diagnostic workup included a physical examination.In conclusion, the study results confirmed that the HBV DNA level is associated with liver fibrosis status and that HBV viral load is strongly correlated with BCP and PC mutations, and it demonstrated that the impaired base pairing 1858-1896 mutations at the base of the bulge in the e encapsidation signal is independently associated with high serum HBV DNA levels.
Detailed description
The progression of liver disease in hepatitis B virus (HBV) infection is fostered by active virus replication. Mutations in the basal core promoter (BCP) and precore (PC) regions of the HBV genome are known to have an impact on viral replication. The aim of the present study was to assess the correlation of mutation profiles in the BCP and PC regions with the viral load in HBeAgnegative chronically infected patients. The HBV genotype, BCP/PC mutations, serum HBV DNA levels, and associated serological markers were analyzed in 92 HBeAgnegative chronically infected patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- the study will be carried out from the blood samples following consultations Hepatogastroenterology in the clinical follow-up of patients chronically infected with HBV. Blood samples are stored in the Virology laboratory as part of legislation on the conservation of samples during Virology analyzes.
Key inclusion criteria (2 listed)
- Patients included will be chronic carriers (HBsAg + for more than 6 months) of HBV, with detectable serum viral load greater than or equal to 100 IU / mL, included in the queue followed by Drs. Dominique Capron and Eric N'Guyen-Khac.
- These patients will not be on anti-HBV treatment.
Key exclusion criteria (6 listed)
- Patients under 18 years old
- Patients with their hepatitis B
- Patients with HBV viral load undetectable or less than 100 IU / mL.
- Immunosuppressive treatments such as corticosteroids or other
- The co-infection with the hepatitis C and / or HIV virus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genotype of HBV for which the HBV viral load is a function of pre-core mutations
Time frame: 2-years
The main objective of the study is toevaluate a genotype of HBV for which the HBV viral load is a function of pre-core mutations in chronically infected patients.The HBV markers (including HBsAg, HBeAg and anti- HBe) were measured with chemiluminescent microparticle immunoassays running on an Architect system.
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 16 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Sandrine Castelain, PU-PH principal investigator
CHU Amiens-Picardie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B Virus, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 2 inclusion and 6 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 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Genotype of HBV for which the HBV viral load is a function of pre-core mutations (time frame: 2-years). 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 16 Jun 2026.