Warfarin anticoagulation for liver fibrosis in patients transplanted for hepatitis C virus infection
| ISRCTN | ISRCTN12504151 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12504151 |
| Protocol serial number | G0701716 |
| Sponsor | Imperial College London (UK) |
| Funder | Medical Research Council |
- 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
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 |
|---|---|
| m.thursz@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled open-label trial (randomisation is stratified by gender and centre) |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Warfarin |
| Primary outcome measure(s) |
Stage of liver fibrosis at end of treatment period (2 years) |
| Key secondary outcome measure(s) |
1. Number of activated hepatic stellate cells per high power field on liver biopsy |
| Completion date | 01/07/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Imperial College
London
W2 1NY
United Kingdom
W2 1NY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| 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.
