Anticoagulation in Liver Fibrosis in Patients With Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients who have been treated for hepatitis C virus (HCV) infection who have failed to respond to anti-viral treatment are often concerned about their ongoing liver disease and are therefore looking for alternative treatments which might prevent fibrosis progression. This view is endorsed by patient representative groups (including Charles Gore at the HepC Trust) who have welcomed this trial protocol.

The study is a single centred, prospective, open labelled design. Practical as well as safety concerns dictated that the study could not be conducted in a blinded fashion, since patients taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1 and Phase 2. Phase 1 (observation phase, 0 to 8 weeks) and Phase 2 (treatment phase with warfarin anticoagulation, 8 to 16 weeks). Study completed at end of Phase 2.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Warfarin

Criteria

Inclusion Criteria:

• Aged >17 years (male and female)

• HCV infection PCR positive

• ALT > 40 iu/ml

• Ishak fibrosis score (within last 5 years) > 2, < 5

• Informed consent

• Failed antiviral therapy for HCV in last 5 years

Exclusion Criteria:

• Patients requiring anticoagulation for existing clinical indications

• Active peptic ulcer disease

• Past history of haemorrhagic stroke

• Thrombocytopaenia (platelets count < 100 x 109 /L)

• Clinical evidence of portal hypertension

• Known cerebrovascular abnormalities;

• HIV antibody positive;

• Alcohol abuse (>40 unites/week)

• Menhorragia

• Pregnancy