Mutations of the Pre-core Region of Hepatite B Virus (HBV)

NCT03625258 | Completed

• 1 other identifier: AOL09-DR-CASTELAIN
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Hepatitis B Virus

Keywords

mutations; infected patients

Outcome Measures

Primary Outcomes (1)

• 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.

  2-years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Sandrine Castelain, MD, PhD

  CHU AMIENS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 10, 2018
• Study Start: January 1, 2009
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: May 17, 2023

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share