Condition category
Not Applicable
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof P McMaster

ORCID ID

Contact details

Liver Surgery
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0265006492

Study information

Scientific title

Acronym

Study hypothesis

Two thirds of patients receiving an orthotopic liver allograft suffer acute graft rejection episodes within the first few weeks post transplant despite current immunosuppressant therapy. This deficiency in current therapy necessitates the administration of high dose steroids in these patients, in a smaller proportion is associated with early graft loss and may in other patients be associated with graft loss from the subsequent development of a chronic graft rejection process. The aim of the proposed trial is to assess the safety and efficacy of the addition to current immunosuppressant therapy of 0.05mg/kg methotrexate given 12 hourly for four days from 24 hours post transplant. The rationale for this therapeutic strategy lies in its common application to the prevention of graft versus host disease after allogeneic bone marrow transplantation; the efficacy of methotrexate in treating established rejection episodes in cardiac allografts; the efficacy of methotrexate in preventing organ allograft rejection in experimental animals.

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

Not Specified

Patient information sheet

Condition

Not Applicable: Liver allograf

Intervention

60 consecutive adult patients who have previously consented to participate in the trial will be randomised to one of two treatment groups at the time of liver transplantation. The treatment groups are 'standard' or 'standard / methotrexate' immunosuppressant regimen. The two treatment groups will be assessed for:
1. Adverse effects attributable to their immunosuppressant therapy
2. Incidence and severity of early graft rejection episodes 3. Use of additional immunosuppressant drugs, particularly corticosteroids
4. Incidence of late acute graft rejection episodes and incidence of chronic graft rejection.

Intervention type

Drug

Phase

Phase II

Drug names

Methotrexate

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2004

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Liver Surgery
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)

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