Phase 2
Completed N=14
Anticoagulation in Liver Fibrosis in Patients With Hepatitis C Virus Infection
Source: ClinicalTrials.gov NCT00180674 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Median Liver Stiffness Value — 7.70; 6.90 kPa — p=0.043
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Liver Stiffness Value |
7.70; 6.90 | 0.043 sig |
| SECONDARY Number of Participants With Adverse Events |
0; 1 | — |
Eligibility 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, 40 unites/week)
- Menhorragia
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00180674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.