Immune Response in Patients With Hepatitis B and C Infection
- Conditions
- Hepatitis CHepatitis B
- Registration Number
- NCT02275221
- Lead Sponsor
- Mid and South Essex NHS Foundation Trust
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
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
Coinfection with HIV Coinfection with hepatitis delta Excessive alcohol use Autoimmune liver disease Metabolic liver disease
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate whether changes in immune cell response for in-patients with Hepatitis B or C can be used to develop better treatment regimes on average 4 weeks 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
- Secondary Outcome Measures
Name Time Method Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis B during their inpatient stay on average 4 weeks 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
Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis C during their inpatient stay on average 4 weels 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
Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis C during their inpatient stay on average 4 weeks 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
Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis B during their inpatient stay on average 4 weeks 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
Trial Locations
- Locations (1)
Basildon Hospital
🇬🇧Basildon, Essex, United Kingdom