Hepatitis, AlcoholicADDUPNCT02404636
Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis
An observational study of Hepatitis, Alcoholic, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial summary
ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview is used to quantitatively estimate: 1. Alcohol use 2. Dietary intake 3. Drug use (legal and illegal) in the weeks preceding onset of acute alcoholic hepatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis, Alcoholic
- What is being tested?
- Interview
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (aged over 18 years) admitted to Queen Elizabeth Hospital Birmingham, UK
Who may be able to join
- acute alcoholic hepatitis
- aged over 18 years
- able to give informed consent
Who cannot join
- evidence of other acute or chronic liver disease
- episode of alcoholic hepatitis in 6 months before admission
- severe hepatic encephalopathy
- delirium
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, B15 2TH
About this study
ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview is used to quantitatively estimate:
- Alcohol use
- Dietary intake
- Drug use (legal and illegal) in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are followed up for 12 months with regard to response to therapy and survival.
The study is intended to explore potential precipitants of alcoholic hepatitis.
- Conditions
- Hepatitis, Alcoholic
- Being tested
- Interview
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Brief structured interview
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic hepatitis | Individuals admitted to hospital with acute alcoholic hepatitis, defined as acute onset of jaundice in the context of recent hazardous alcohol use and the absence of other liver disease Receives: Other: Interview | |
| Hazardous alcohol use | Individuals admitted to hospital for any cause who drink hazardous quantities of alcohol but without evidence of alcoholic hepatitis or advanced liver disease Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in alcohol intake, dietary intake or drug use before illness
Behavior before admission (Brief structured interview)
Measured: 1 month
Secondary outcomes (2)
Survival after admission (Brief structured interview)
Survival
Measured: 12 months
Response to treatment (Brief structured interview)
Response to treatment (corticosteroids, pentoxifylline or supportive medical care) after 1 week, measured by Lille score
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, AlcoholicStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Parker, University Hospital Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404636
- Sponsor's protocol ID
- RRK4357
- Acronym
- ADDUP
- Status last verified
- Apr 2017
- First submitted
- 26 Mar 2015
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Diet and Drug Use Preceding Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT02404636
- Acronym / sponsor ID
- ADDUP / RRK4357
- Conditions
- Hepatitis, Alcoholic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 31 Mar 2015 (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.
ADDUP is an observational study of patients with alcoholic hepatitis. A structured interview is used to quantitatively estimate:
- Alcohol use
- Dietary intake
- Drug use (legal and illegal) in the weeks preceding onset of acute alcoholic hepatitis. After interview patients are followed up for 12 months with regard to response to therapy and survival.
The study is intended to explore potential precipitants of alcoholic hepatitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcoholic hepatitis | – | Other: InterviewIndividuals admitted to hospital with acute alcoholic hepatitis, defined as acute onset of jaundice in the context of recent hazardous alcohol use and the absence of other liver disease |
| Hazardous alcohol use | – | Other: InterviewIndividuals admitted to hospital for any cause who drink hazardous quantities of alcohol but without evidence of alcoholic hepatitis or advanced liver disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged over 18 years) admitted to Queen Elizabeth Hospital Birmingham, UK
Key inclusion criteria (3 listed)
- acute alcoholic hepatitis
- aged over 18 years
- able to give informed consent
Key exclusion criteria (4 listed)
- evidence of other acute or chronic liver disease
- episode of alcoholic hepatitis in 6 months before admission
- severe hepatic encephalopathy
- delirium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewBrief structured interview | Other | Alcoholic hepatitis, Hazardous alcohol use |
Primary outcome
Changes in alcohol intake, dietary intake or drug use before illness
Time frame: 1 month
Behavior before admission (Brief structured interview)
2 secondary outcomes
Survival after admission (Brief structured interview)
Time frame: 12 months
Response to treatment (Brief structured interview)
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Alcoholic, run by University Hospital Birmingham 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 4 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 10 Apr 2017. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in alcohol intake, dietary intake or drug use before illness (time frame: 1 month). 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 10 Apr 2017.