A pilot study of thalidomide therapy for alcoholic hepatitis

ISRCTN	ISRCTN40686096
DOI	https://doi.org/10.1186/ISRCTN40686096
Secondary identifying numbers	N0265006466

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Prof DH Adams
Scientific

Liver Medicine
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Thalidomide
Primary outcome measure	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 study start date	01/01/2006
Completion date	01/01/2007
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2006
Date of final enrolment	01/01/2007

Liver Medicine

Birmingham
B15 2TH
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

University Hospital Birmingham NHS Trust (UK) - Internal funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan