Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
24/11/2011
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof DH Adams

ORCID ID

Contact details

Liver Medicine
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes