CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Warfarindrug
Likely dose
Warfarin (dose not specified)AI-extracted
Key inclusion· 5
  • Age >17 years
  • HCV PCR positive
  • ALT >40 IU/mL
  • Ishak fibrosis score 3-4 (within last 5 years)
Key exclusion· 10
  • Already requiring anticoagulation for clinical indications
  • Active peptic ulcer disease
  • History of hemorrhagic stroke
  • Platelets <100 × 10⁹/L

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00180674
NCT00180674Phase 2Completed

Anticoagulation for Liver Fibrosis in Patients With Hepatitis C Virus Infection: Pilot Study

Imperial College London·interventional·Posted Sep 16, 2005·Updated Dec 1, 2020

In Brief

A Phase 2 clinical trial evaluating Warfarin for Liver Fibrosis. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Fibrosis
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartAug 1, 2005
Primary CompletionSep 1, 2006
Study CompletionOct 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 20.8 years ago

Interventions

Warfarindrug