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Anticoagulation in Liver Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00180674
First Posted: September 16, 2005
Last Update Posted: November 11, 2016
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.
Information provided by:
Imperial College London
  Purpose

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 Intervention Phase
Liver Fibrosis Drug: Warfarin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Reduction in fibrosis biomarkers

Secondary Outcome Measures:
  • Safety

Enrollment: 12
Study Start Date: August 2005
Study Completion Date: October 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
  Contacts and Locations
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
United Kingdom
St Mary's Hospital NHS Trust
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Mark R Thursz, MBBS, FRCP St Mary's Hospital & Imperial College London
  More Information

ClinicalTrials.gov Identifier: NCT00180674     History of Changes
Other Study ID Numbers: aclf01
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: November 11, 2016
Last Verified: September 2005

Keywords provided by Imperial College London:
Hepatic fibrosis
anticoagulation
Coumarin
Warfarin
Chronic hepatitis C virus infection

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Warfarin
Anticoagulants