Anticoagulation in Liver Fibrosis in Patients With Hepatitis C Virus Infection
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|ClinicalTrials.gov Identifier: NCT00180674|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 8, 2019
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 trial will be a randomised cross over study with 15 patients in each group. Each patient will receive eight weeks of anticoagulation and eight weeks of observation.
|Condition or disease||Intervention/treatment||Phase|
|Liver Fibrosis||Drug: Warfarin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Anticoagulation for Liver Fibrosis in Patients With Hepatitis C Virus Infection: Pilot Study|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||September 2006|
|Actual Study Completion Date :||October 2006|
Experimental: Warfarin anticoagulation
Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period).
- Changes in fibrosis biomarkers [ Time Frame: 16 weeks ]Changes in median liver stiffness values
- Incidence of adverse event [ Time Frame: 16 weeks ]Safety of treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180674
|St Mary's Hospital NHS Trust|
|London, United Kingdom, W2 1NY|
|Principal Investigator:||Mark R Thursz, MBBS, FRCP||St Mary's Hospital & Imperial College London|