Immune Response in Patients With Hepatitis B and C Infection

Hepatitis C Clinical Trial

Official title:

Investigation and Elucidation of Host Immune Responses in Patients With Hepatitic B and C Virus Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02275221
• Other study ID #: B664
• Status: Recruiting
• Start date: August 2013
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Mid and South Essex NHS Foundation Trust
• Contact: Carol L Alves, BSc, MRes
• Phone: 0845 155 3111
• Email: Carol.Alves[@]btuh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV infected patients in a number of different immunological assays, the investigators hope to identify any changes in the number and function of these immune cells and to investigate how these changes contribute to viral persistence and disease progression.

Description:

Hepatitis B virus (HBV) and C (HCV) are the leading causes of liver disease worldwide. Approximately 400 million people worldwide are chronically infected with HBV world wide and it is estimated that 3% of the entire world population is infected with HCV and yet there is still no vaccine available.

Chronic viral hepatitis infection is primarily the result of a complex interaction between the virus and an impaired host immune response. The host immune response has a unique role in HBV and HCV infection because it contributes not only to viral control clinical recovery and protective immunity but also to the development of chronic hepatitis and liver cirrhosis. There is currently no cure for most patients who already have chronic HBV and HCV infection and a proportion of patients fail to respond to current antiviral regimens. Since these patient remain at risk for disease progression it is crucial to investigate host immune responses and to determine the precise role of these responses in disease outcome.

Using peripheral blood mononuclear cells (PBMC) and serum collection from HBV and HCV infected patients in a number of different immunological assays, we hope to identify any changes in the number and function of these immune cells and to investigate how these changes contribute to viral persistence and disease progression. This information can be utilised to develop more effective treatment regimens in order to reduce the current global burden of these diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

Chronic Hepatitis B patients At all stages of infection Treatment naive and previously treated Longitudinal samples from patients treated with antiviral agents and interferon

Chronic Hepatitis C patients All genotypes - treatment naive and previously treated Longitudinal samples from patients treated with interferon and STATIC therapy

Exclusion Criteria:

Coinfection with HIV Coinfection with hepatitis delta Excessive alcohol use Autoimmune liver disease Metabolic liver disease

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C

Locations

Country	Name	City	State
United Kingdom	Basildon Hospital	Basildon	Essex

Sponsors (2)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust	Foundation for Liver Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate whether changes in immune cell response for in-patients with Hepatitis B or C can be used to develop better treatment regimes	The principle aim of this study is to investigate exactly how patients; immune cells interact with hepatitis B and C virus after becoming infected. By understanding how the immune cells interact with the virus it will be possible to use this information to develop better treatment regimens for these patients	on average 4 weeks
Secondary	Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis B during their inpatient stay	During their in-patient stay patients with Hepatitis B will have their cytokine expression recorded to determine whether this has an effect on their immune cell response	on average 4 weeks
Secondary	Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis C during their inpatient stay	During their in-patient stay patients with Hepatitis C will have their cytokine expression recorded to determine whether this has an effect on their immune cell response	on average 4 weeks
Secondary	Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis B during their inpatient stay	During their in-patient stay patients with Hepatitis B will have their t-cell populations recorded to determine whether this has an effect on their immune cell response	on average 4 weeks
Secondary	Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis C during their inpatient stay	During their in-patient stay patients with Hepatitis C will have their t-cell populations recorded to determine whether this has an effect on their immune cell response	on average 4 weels