Warfarin Anticoagualtion for liver fibrosis in patients transplanted for hepatitis C virus infection. - WAFT-C

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006221-77-GB

Enrollment

Registered

2007-05-30

Start date

2007-06-26

Completion date

Unknown

Last updated

2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver fibrosis in patients infected with hepatitis C virus after liver transplantation. MedDRA version: 9.1 Level: HLT Classification code 10019669 Term: Hepatic fibrosis and cirrhosis MedDRA version: 9.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C MedDRA version: 9.1 Level: LLT Classification code 10010186 Term: Complications of transplanted liver

Interventions

Product Name: Warfarin Pharmaceutical Form: Tablet INN or Proposed INN: WARFARIN SODIUM CAS Number: 129066 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 1-5

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HCV infection. 2. Age >17. 3. Liver transplant within previous 4 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 < 90 x109 /L). 3. Large oesophageal varices persisting post-transplant. 4. Known cerebrovascular abnormalities. 5. HIV antibody positive. 6. Baseline fibrosis score of 2 or greater.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the impact of anticoagulation on the progression of liver fibrosis in patients who have received a liver transplant for hepatitis C related disease. ;Secondary Objective: 1. To determine whether hepatic stellate cell activation is diminished in patients who are anticoagulated. 2. To determine if the presence of thrombophilia promotes fibrosis in patients after liver transplantation. 3. To evaluate non-invasive markers of liver fibrosis. ;Primary end point(s): Stage of liver fibrosis on liver biopsy after two years of anticoagulation therapy compared to controls.	—

Measure

Time frame

Main Objective: To evaluate the impact of anticoagulation on the progression of liver fibrosis in patients who have received a liver transplant for hepatitis C related disease. ;Secondary Objective: 1. To determine whether hepatic stellate cell activation is diminished in patients who are anticoagulated. 2. To determine if the presence of thrombophilia promotes fibrosis in patients after liver transplantation. 3. To evaluate non-invasive markers of liver fibrosis. ;Primary end point(s): Stage of liver fibrosis on liver biopsy after two years of anticoagulation therapy compared to controls.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026