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Anticoagulation in Liver Fibrosis

This study has been completed.
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT00180674
First received: September 13, 2005
Last updated: November 10, 2016
Last verified: September 2005
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: September 13, 2005
Last Updated: November 10, 2016
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on December 05, 2016