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Trial record 19 of 440 for:    hepatitis b | Open Studies

Immune Response in Patients With Hepatitis B and C Infection

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Basildon and Thurrock University Hospitals NHS Foundation Trust
Sponsor:
Collaborator:
Foundation for Liver Research
Information provided by (Responsible Party):
Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT02275221
First received: October 20, 2014
Last updated: October 23, 2014
Last verified: October 2014
  Purpose

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
Hepatitis B
Hepatitis C

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Investigation and Elucidation of Host Immune Responses in Patients With Hepatitic B and C Virus Infection

Resource links provided by NLM:


Further study details as provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:

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 [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: on average 4 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: on average 4 weels ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hepatitis B and C
Hepatitis B and 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hepatitis B and C

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02275221

Contacts
Contact: Carol L Alves, BSc, MRes 0845 155 3111 ext 3599 Carol.Alves@btuh.nhs.uk

Locations
United Kingdom
Basildon and Thurrock University Hospitals NHS FT Recruiting
Basildon, Essex, United Kingdom, SS16 5NL
Contact: Carol L Alves, BSc, MRes    01268 529400 ext 3599    Carol.Alves@btuh.nhs.uk   
Principal Investigator: Gavin Wright, MBBS MRCP         
Sponsors and Collaborators
Basildon and Thurrock University Hospitals NHS Foundation Trust
Foundation for Liver Research
Investigators
Principal Investigator: Gavin Wright, MBBS MRCP Basildon and Thurrock University Hospitals NHS FT
  More Information

No publications provided

Responsible Party: Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02275221     History of Changes
Other Study ID Numbers: B664
Study First Received: October 20, 2014
Last Updated: October 23, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Basildon and Thurrock University Hospitals NHS Foundation Trust:
Hepatitis B (HBV)
Hepatitis C (HCV)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis C
Hepatitis, Viral, Human
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepadnaviridae Infections
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014