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Trial record 19 of 343 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Immune Response in Patients With Hepatitis B and C Infection

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ClinicalTrials.gov Identifier: NCT02275221
Recruitment Status : Recruiting
First Posted : October 27, 2014
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
Foundation for Liver Research
Information provided by (Responsible Party):
Basildon and Thurrock University Hospitals 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.

Condition or disease
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 Type : Observational
Estimated 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
Study Start Date : August 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Hepatitis B and C
Hepatitis B and C



Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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

  2. 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 ]
    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

  3. 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 ]
    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

  4. 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 ]
    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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Basildon and Thurrock University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02275221     History of Changes
Other Study ID Numbers: B664
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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 C
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections