Clinical trial NCT02275221: Immune Response in Patients With Hepatitis B and C Infection
Official title: Investigation and Elucidation of Host Immune Responses in Patients With Hepatitic B and C Virus Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B
Hepatitis C
Keywords: Hepatitis B (HBV)
Hepatitis C (HCV)
Lead sponsor: Mid and South Essex NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Foundation for Liver Research
First posted: 2014-10-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatitis B and C

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.

Eligibility criteria: 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

Primary outcomes:
measure: To investigate whether changes in immune cell response for in-patients with Hepatitis B or C can be used to develop better treatment regimes
timeFrame: on average 4 weeks
Secondary outcomes:
measure: Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis B during their inpatient stay
timeFrame: on average 4 weeks
measure: Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis C during their inpatient stay
timeFrame: on average 4 weeks
measure: Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis B during their inpatient stay
timeFrame: on average 4 weeks
measure: Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis C during their inpatient stay
timeFrame: on average 4 weels
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon Hospital
state: Essex
Study officials:
affiliation: Basildon and Thurrock University Hospitals NHS FT
name: Gavin Wright, MBBS MRCP
role: PRINCIPAL_INVESTIGATOR
References: