Anticoagulation in Liver Fibrosis - Full Text View

Sponsored by:	Imperial College London
Information provided by:	Imperial College London
ClinicalTrials.gov Identifier:	NCT00180674

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 II

MedlinePlus related topics: Blood Thinners Hepatitis Hepatitis C

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Anticoagulation for Liver Fibrosis in Patients With Hepatitis C Virus Infection: Pilot Study

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Reduction in fibrosis biomarkers

Secondary Outcome Measures:

Safety

Estimated Enrollment:	20
Study Start Date:	August 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180674

Contacts

Contact: Mark R Thursz, MBBS, FRCP	0207 594 3851	m.thursz@imperial.ac.uk
Contact: Quentin M Anstee, MBBS, MRCP	0207 594 3834	q.anstee@imperial.ac.uk

Locations

United Kingdom
St Mary's Hospital NHS Trust	Recruiting
London, United Kingdom, W2 1NY
Contact: Mark R Thursz, MBBS, FRCP 0207 594 3851 m.thursz@imperial.ac.uk
Contact: Quentin M Anstee, MBBS, MRCP q.anstee@imperial.ac.uk
Principal Investigator: Mark R Thursz, MBBS, FRCP

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator:

Mark R Thursz, MBBS, FRCP

St Mary's Hospital & Imperial College London

More Information

Study ID Numbers:	aclf01
Study First Received:	September 13, 2005
Last Updated:	September 18, 2007
ClinicalTrials.gov Identifier:	NCT00180674
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:

Hepatic fibrosis
anticoagulation
Coumarin
Warfarin
Chronic hepatitis C virus infection

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Hepatic fibrosis
Digestive System Diseases
Hepatitis, Chronic

Fibrosis
Warfarin
Liver Cirrhosis
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009