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Trial record 21 of 291 for:    warfarin AND anticoagulation

Anticoagulation in Liver Fibrosis in Patients With Hepatitis C Virus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00180674
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief 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 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Warfarin anticoagulation
Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period).
Drug: Warfarin



Primary Outcome Measures :
  1. Changes in fibrosis biomarkers [ Time Frame: 16 weeks ]
    Changes in median liver stiffness values


Secondary Outcome Measures :
  1. Incidence of adverse event [ Time Frame: 16 weeks ]
    Safety of treatment



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18 - 70 (male and female)
  • HCV infection PCR positive
  • ALT > 60
  • Liver fibrosis score (within last 5 years) > 2, < 5
  • Informed consent

Exclusion Criteria:

  • Clinical evidence of portal hypertension (USS or varices)
  • Contra-indications for anticoagulation including (but not limited to):

    • Recent peptic ulcer disease
    • Thrombocytopaenia (<120 x 10^9)
    • Falls
    • Haemorrhagic stroke
  • Alcohol abuse (> 40 u/week)
  • Continuing injection drug use
  • Already on anticoagulants

Information from the National Library of Medicine

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


Locations
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United Kingdom
St Mary's Hospital NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Mark R Thursz, MBBS, FRCP St Mary's Hospital & Imperial College London

Additional Information:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT00180674     History of Changes
Other Study ID Numbers: aclf01
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Imperial College London:
Hepatic fibrosis
anticoagulation
Coumarin
Warfarin
Chronic hepatitis C virus infection
Additional relevant MeSH terms:
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Warfarin
Infection
Hepatitis C
Hepatitis
Liver Cirrhosis
Fibrosis
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Anticoagulants