Immune Response in Patients With Hepatitis B and C Infection

NCT02275221 | Unknown

• 1 other identifier: B664
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B; Hepatitis C

Keywords

Hepatitis B (HBV); Hepatitis C (HCV)

Outcome Measures

Primary Outcomes (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

  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

  on average 4 weeks

Secondary Outcomes (4)

• Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis B during their inpatient stay

  on average 4 weeks

• Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis C during their inpatient stay

  on average 4 weeks

• Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis B during their inpatient stay

  on average 4 weeks

• Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis C during their inpatient stay

  on average 4 weels

Study Arms (1)

Hepatitis B and C

Hepatitis B and C

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hepatitis B and C

You may qualify if:

• 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

You may not qualify if:

• Coinfection with HIV Coinfection with hepatitis delta Excessive alcohol use Autoimmune liver disease Metabolic liver disease

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• Foundation for Liver Research: collaborator

Study Sites (1)

Basildon Hospital

Basildon, Essex, SS16 5NL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Hepatitis B; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Gavin Wright, MBBS MRCP

  Basildon and Thurrock University Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol L Alves, BSc, MRes

CONTACT

0845 155 3111; Carol.Alves@btuh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 27, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)