Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265006466
Study information
Scientific title
Acronym
Study hypothesis
Will suppression of tumour necrotising factor alpha (TNF-a) production by the use of thalidomide lead to a reduction in morbidity and/or mortality in alcoholic hepatitis?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Alcoholic hepatitis
Intervention
Patients referred to the Liver Unit for management of acute alcoholic hepatitis will be invited to participate in the trial provided that they fulfill inclusion criteria according to our proposed protocol. They will be given the study medications or placebo for a total of four weeks and will be monitored during and following this period of trial therapy.
Please note, this trial never started due to logistic problems.
Intervention type
Drug
Phase
Not Applicable
Drug names
Thalidomide
Primary outcome measures
Survival or death, since severe AH carries a mortality of 50% within two months.
Secondary outcome measures
1. Onset of complications such as bacterial or fungal sepsis
2. Renal failure
3. Gastrointestinal haemorrhage
Overall trial start date
01/01/2006
Overall trial end date
01/01/2007
Reason abandoned
Lack of staff/facilities/resources
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2006
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liver Medicine
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK) - Internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary