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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 13 January 2015
Main ID:  ISRCTN40686096
Date of registration: 30/09/2005
Prospective Registration: Yes
Primary sponsor: Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Public title: A pilot study of thalidomide therapy for alcoholic hepatitis
Scientific title:
Date of first enrolment: 01/01/2006
Target sample size: 0
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN40686096
Study type:  Interventional
Study design:  Randomised controlled trial (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: DH    Adams
Address:  Liver Medicine Queen Elizabeth Hospital B15 2TH Birmingham United Kingdom
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Not provided at time of registration
Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Not Specified
Health Condition(s) or Problem(s) studied
Alcoholic hepatitis
Digestive System
Alcoholic liver disease
Intervention(s)
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.
Primary Outcome(s)
Survival or death, since severe AH carries a mortality of 50% within two months.
Secondary Outcome(s)
1. Onset of complications such as bacterial or fungal sepsis
2. Renal failure
3. Gastrointestinal haemorrhage
Secondary ID(s)
N0265006466
Source(s) of Monetary Support
University Hospital Birmingham NHS Trust (UK) - Internal funding
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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