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

Hepatitis B Virus Clinical Trial

— HEPATITEB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03625258
• Other study ID #: AOL09-DR-CASTELAIN
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: February 1, 2017

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 1, 2017
• Est. primary completion date: February 1, 2017
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B Virus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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