HepatitisNCT02275195
Immune Cell Dysfunction in Severe Alcoholic Hepatitis
An observational study of Hepatitis, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients attending / being treated at the Basildon Hospital for acute severe alcoholic hepatitis will be identified as potential participants in these studies
Who may be able to join
- Age 18-65 years
- Patients presented with severe alcoholic hepatitis with a Maddrey score (discriminant function) of >32 (The Maddrey score uses various blood results on a patient to define the severity of alcoholic hepatitis e.g.bilirubin etc).
- Ongoing abuse of alcohol (drinking in excess of 28 units/wk)
Who cannot join
- Co-infection with HIV/Hepatitis B / Hepatitis C virus infection.
- Patients with autoimmune liver disease.
- Patients with metabolic liver disease.
- Patients with significant psychiatric and/or neurological co-morbidity.
- Hepatocellular carcinoma or other neoplastic disease
- Pregnancy or breast feeding of infants.
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
Through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. the investigators will examine the role of different cells of the immune system and how they may determine the outcome of this condition. The investigators will also look at how established treatment strategies impact on the frequency and function of these cell subsets.
Read the detailed description
Through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. The investigators will examine the role of different cells of the immune system and how they may determine the outcome of this condition. The investigators will also look at how established treatment strategies impact on the frequency and function of these cell subsets.
Alcohol is the most common cause of liver disease in the developed world and results in the death of 2.5 million people annually. It is a causal factor in more than 60 major types of diseases and injuries and approximately 4.5% of the global burden of disease and injury is attributable to alcohol. Acute alcoholic hepatitis (AAH) is perhaps the most florid form of ALD and the leading cause of mortality in these patients is the development of sepsis which occurs in up to 40% of these patients and has a mortality rate of 50%.
By gaining a better understanding of the relationship between elements of the immune system and the progression to severe alcoholic hepatitis, it will allow the formulation of more effective treatment strategies for this condition.
Patients who agree to participate in this study will have an extra 40mls of blood drawn for scientific studies at the same time as routine blood samples are taken as part of their ongoing care.
- Conditions
- Hepatitis
- Keywords
- hepatitis, alcohol
- Medical subject headings
- Hepatitis
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine and changes to immune cell responses for outpatients with Alcoholic Hepatitis
Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis
Measured: Participants will be followed-up during thier hospital stay, which averages 4 weeks
Secondary outcomes (3)
Change from baseline to end of study in flow cytometry for patients with Alcoholic Hepatitis
Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis
Measured: on average 4 weeks
Change from baseline to end of study in real time PCR for patients with Alcoholic Hepatitis
Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis
Measured: On average 4 weks
Change from baseline to end of study in cell cultures for patients with Alcoholic Hepatitis
Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis
Measured: on average 4 weeks
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 startNov 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 HepatitisStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gavin Wright, MBBS MRCP, Principal investigator, Basildon and Thurrock University Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275195
- Sponsor's protocol ID
- B663
- Status last verified
- Jan 2024
- First submitted
- 17 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
- Immune Cell Dysfunction in Severe Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT02275195
- Acronym / sponsor ID
- B663
- Conditions
- Hepatitis
- Keywords
- hepatitis, alcohol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2013
- 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.
Through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. the investigators will examine the role of different cells of the immune system and how they may determine the outcome of this condition. The investigators will also look at how established treatment strategies impact on the frequency and function of these cell subsets.
Detailed description
Through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. The investigators will examine the role of different cells of the immune system and how they may determine the outcome of this condition. The investigators will also look at how established treatment strategies impact on the frequency and function of these cell subsets.
Alcohol is the most common cause of liver disease in the developed world and results in the death of 2.5 million people annually. It is a causal factor in more than 60 major types of diseases and injuries and approximately 4.5% of the global burden of disease and injury is attributable to alcohol. Acute alcoholic hepatitis (AAH) is perhaps the most florid form of ALD and the leading cause of mortality in these patients is the development of sepsis which occurs in up to 40% of these patients and has a mortality rate of 50%.
By gaining a better understanding of the relationship between elements of the immune system and the progression to severe alcoholic hepatitis, it will allow the formulation of more effective treatment strategies for this condition.
Patients who agree to participate in this study will have an extra 40mls of blood drawn for scientific studies at the same time as routine blood samples are taken as part of their ongoing care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending / being treated at the Basildon Hospital for acute severe alcoholic hepatitis will be identified as potential participants in these studies
Key inclusion criteria (3 listed)
- Age 18-65 years
- Patients presented with severe alcoholic hepatitis with a Maddrey score (discriminant function) of >32 (The Maddrey score uses various blood results on a patient to define the severity of alcoholic hepatitis e.g.bilirubin etc).
- Ongoing abuse of alcohol (drinking in excess of 28 units/wk)
Key exclusion criteria (6 listed)
- Co-infection with HIV/Hepatitis B / Hepatitis C virus infection.
- Patients with autoimmune liver disease.
- Patients with metabolic liver disease.
- Patients with significant psychiatric and/or neurological co-morbidity.
- Hepatocellular carcinoma or other neoplastic 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 determine and changes to immune cell responses for outpatients with Alcoholic Hepatitis
Time frame: Participants will be followed-up during thier hospital stay, which averages 4 weeks
Characterize the relationship between various elements of patients immune system and the progression of an episode of severe Alcoholic Hepatitis
3 secondary outcomes
Change from baseline to end of study in flow cytometry for patients with Alcoholic Hepatitis
Time frame: on average 4 weeks
Change from baseline to end of study in real time PCR for patients with Alcoholic Hepatitis
Time frame: On average 4 weks
Change from baseline to end of study in cell cultures for patients with Alcoholic Hepatitis
Time frame: on average 4 weeks
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
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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, 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 3 inclusion and 6 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 (01268 529400 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 determine and changes to immune cell responses for outpatients with Alcoholic Hepatitis (time frame: Participants will be followed-up during thier hospital stay, which averages 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; AzTrials last refreshed its copy on 28 Oct 2026.