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ISRCTN
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ISRCTN12504151
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ClinicalTrials.gov identifier
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Public title
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Warfarin Anticoagulation for liver Fibrosis in patients Transplanted for hepatitis C virus infection
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Scientific title
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Acronym
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WAFT-C
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Serial number at source
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G0701716
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Study hypothesis
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Anticoagulation reduces the rate of liver fibrosis in patients who have received a liver transplant for hepatitis C related disease.
More details can be found at:
http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0701716&CaseId=11006
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Lay summary
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Ethics approval
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The Royal Free Hospital and Medical School Research Ethics Committee gave approval on the 20th June 2007 (ref: 07/Q0501/79)
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Study design
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Randomised controlled open-label trial (randomisation is stratified by gender and centre)
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Liver fibrosis, hepatitis C
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Participants - inclusion criteria
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1. Hepatitis C virus (HCV) infection
2. Age greater than 17, either sex
3. Liver transplant within previous four months
4. Informed consent
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Participants - exclusion criteria
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1. Patients requiring anticoagulation for existing clinical indications
2. Standard contraindications to anticoagulation (active peptic ulcer disease, past history of haemorrhagic stroke, thrombocytopaenia (platelets count less than 90 x10^9/L)
3. Large oesophageal varices persisting post-transplant
4. Cerebrovascular abnormalities on pre-transplant computed tomography (CT) scan
5. Human immunodeficiency virus (HIV) antibody positive
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Anticipated start date
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01/07/2007
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Anticipated end date
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01/07/2012
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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90
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Interventions
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Warfarin (anticoagulation) for a duration of two years at a dose to maintain the international normalised ratio (INR) at 2 - 3. The warfarin will be taken orally on a daily basis. The control group will receive standard post-transplant care only. The follow-up duration of the trial is the duration of the intervention i.e., two years, after which patients will be followed up as per routine clinical care in their respective liver transplant clinics.
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Primary outcome measure(s)
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Stage of liver fibrosis at end of treatment period (two years).
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Secondary outcome measure(s)
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1. Number of activated hepatic stellate cells per high power field on liver biopsy
2. Non-invasive measures of liver fibrosis
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Sources of funding
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Medical Research Council (MRC) (UK) - experimental grant (ref: G0701716)
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Trial website
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Publications
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Contact name
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Prof
Mark
Thursz
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Address
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Hepatology Section
Imperial College St Mary’s Campus
Norfolk Place
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City/town
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London
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Zip/Postcode
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W2 1NY
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Country
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United Kingdom
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Tel
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+44 (0)20 7594 3851 or 7886 1903
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Fax
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+44 (0)20 7706 9161
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Email
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m.thursz@imperial.ac.uk
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Sponsor
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Imperial College London (UK)
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Address
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Clinical Research Office
G02, Sir Alexander Fleming Building
South Kensington
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City/town
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London
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Zip/Postcode
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SW7 2AZ
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Country
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United Kingdom
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Sponsor website:
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http://www3.imperial.ac.uk/
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Date applied
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17/04/2007
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Last edited
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03/11/2009
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Date ISRCTN assigned
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31/10/2008
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