Hepatitis BNCT02275221
Immune Response in Patients With Hepatitis B and C Infection
An observational study of Hepatitis B and Hepatitis C, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis B, Hepatitis C
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2013to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatitis B and C
Who may be able to join
- 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
Who cannot join
- Coinfection with HIV Coinfection with hepatitis delta Excessive alcohol use Autoimmune liver disease Metabolic liver disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Basildon Hospital
Basildon, Essex, SS16 5NL
Carol L Alves, BSc, MRes, 01268 529400 ext. 3599, Carol.Alves@btuh.nhs.uk
Gavin Wright, MBBS MRCP
About this study
Official title: Investigation and Elucidation of Host Immune Responses in Patients With Hepatitic B and C Virus Infection
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.
Read the 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.
- Conditions
- Hepatitis B, Hepatitis C
- Keywords
- Hepatitis B (HBV), Hepatitis C (HCV)
- Medical subject headings
- Hepatitis B, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis B and C | Hepatitis B and C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: on average 4 weeks
Changes in immune cell reaction as determined by cytokine expression for patients with Hepatitis C during their inpatient stay
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
Measured: on average 4 weeks
Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis B during their inpatient stay
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
Measured: on average 4 weeks
Changes in immune cell reaction as determined by t-cell populations for patients with Hepatitis C during their inpatient stay
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
Measured: on average 4 weels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startAug 2013
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Liver Research
- Responsible party
- Sponsor
- Investigators
- Gavin Wright, MBBS MRCP, Principal investigator, Basildon and Thurrock University Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275221
- Sponsor's protocol ID
- B664
- Status last verified
- Jan 2024
- First submitted
- 20 Oct 2014
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation and Elucidation of Host Immune Responses in Patients With Hepatitic B and C Virus Infection
- ClinicalTrials.gov ID
- NCT02275221
- Acronym / sponsor ID
- B664
- Conditions
- Hepatitis B, Hepatitis C
- Keywords
- Hepatitis B (HBV), Hepatitis C (HCV)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Foundation for Liver Research
- Study start
- Aug 2013 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis B and C | – | –Hepatitis B and C |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatitis B and C
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Coinfection with HIV Coinfection with hepatitis delta Excessive alcohol use Autoimmune liver disease Metabolic liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Hepatitis B
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gavin Wright, MBBS MRCP principal investigator
Basildon and Thurrock University Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Hepatitis C, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carol L Alves, BSc, MRes (0845 155 3111 ext. 3599, Carol.Alves@btuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: on average 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.