Immune Response in Patients With Hepatitis B and C Infection

Sponsor

Mid and South Essex NHS Foundation Trust (Other)

Overall Status

Recruiting

CT.gov ID

NCT02275221

Collaborator

Foundation for Liver Research (Other)

150

Enrollment

Location

112

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Hepatitis C

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Hepatitis B and C Hepatitis B and C

Outcome Measures

Primary Outcome Measures

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

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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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