Warfarin anticoagulation for liver fibrosis in patients transplanted for hepatitis C virus infection

ISRCTN	ISRCTN12504151
DOI	https://doi.org/10.1186/ISRCTN12504151
Secondary identifying numbers	G0701716

Submission date: 17/04/2007
Registration date: 31/10/2008
Last edited: 05/09/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Mark Thursz
Scientific

Hepatology Section
Imperial College St Mary's Campus
Norfolk Place
London
W2 1NY
United Kingdom

Phone	+44 (0)20 7594 3851 or 7886 1903
Email	m.thursz@imperial.ac.uk

Study information

Study design	Randomised controlled open-label trial (randomisation is stratified by gender and centre)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Warfarin Anticoagulation for liver Fibrosis in patients Transplanted for hepatitis C virus infection
Study acronym	WAFT-C
Study objectives	Anticoagulation reduces the rate of liver fibrosis in patients who have received a liver transplant for hepatitis C related disease.
Ethics approval(s)	The Royal Free Hospital and Medical School Research Ethics Committee, 20/06/2007, ref: 07/Q0501/79
Health condition(s) or problem(s) studied	Prevention of liver fibrosis in patients who have received a liver transplant as a result of hepatitis C virus (HCV) infection
Intervention	Warfarin (anticoagulation) for a duration of 2 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., 2 years, after which patients will be followed up as per routine clinical care in their respective liver transplant clinics.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Warfarin
Primary outcome measure	Stage of liver fibrosis at end of treatment period (2 years)
Secondary outcome measures	1. Number of activated hepatic stellate cells per high power field on liver biopsy 2. Non-invasive measures of liver fibrosis
Overall study start date	01/07/2007
Completion date	01/07/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	17 Years
Sex	Both
Target number of participants	90
Key inclusion criteria	1. Hepatitis C virus (HCV) infection 2. Aged over 17 years, either sex 3. Liver transplant within previous 4 months 4. Informed consent
Key exclusion criteria	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
Date of first enrolment	01/07/2007
Date of final enrolment	01/07/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Imperial College

London
W2 1NY
United Kingdom

Sponsor information

Imperial College London (UK)
University/education

Clinical Research Office
G02, Sir Alexander Fleming Building
South Kensington
London
SW7 2AZ
England
United Kingdom

Website	http://www3.imperial.ac.uk/
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Research organisation

Medical Research Council
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	1-year interim results presented at the International Liver Congress	23/04/2015	05/09/2023	No	No
Thesis results	1-year interim results	01/11/2011	05/09/2023	No	No

Editorial Notes

05/09/2023: The following changes have been made:
1. Abstract reference added.
2. Thesis link added.
18/09/2017: No publications found, verifying study status with principal investigator.