Anticoagulation in Liver Fibrosis in Patients With Hepatitis C Virus Infection

NCT00180674 | Completed Phase 2 Results

• 1 other identifier: aclf01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 study is a single centred, prospective, open labelled design. Practical as well as safety concerns dictated that the study could not be conducted in a blinded fashion, since patients taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1 and Phase 2. Phase 1 (observation phase, 0 to 8 weeks) and Phase 2 (treatment phase with warfarin anticoagulation, 8 to 16 weeks). Study completed at end of Phase 2.

Conditions

Liver Fibrosis

Keywords

Hepatic fibrosis; anticoagulation; Coumarin; Warfarin; Chronic hepatitis C virus infection

Outcome Measures

Primary Outcomes (1)

• Median Liver Stiffness Value

  Median liver stiffness at 16-weeks following the 8-week period of anticoagulation, compared to 8-week period of observation. kPa values reported are the values from completion of the period of anticoagulation at week 16 versus completion of the observation period at week 8, and start of the observation period at week 0.

  Baseline (start of the observation period at week 0), 8-weeks (completion of the observation period) and 16-weeks (completion of the period of anticoagulation)

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  8-week period of warfarin treatment and 8-week observation period (16 weeks)

Study Arms (1)

Warfarin anticoagulation

EXPERIMENTAL

Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period).

Drug: Warfarin

Interventions

Warfarin DRUG

Warfarin anticoagulation

Eligibility Criteria

• Age: 17 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>17 years (male and female)
• HCV infection PCR positive
• ALT \> 40 iu/ml
• Ishak fibrosis score (within last 5 years) \> 2, \< 5
• Informed consent
• Failed antiviral therapy for HCV in last 5 years

You may not qualify if:

• Patients requiring anticoagulation for existing clinical indications
• Active peptic ulcer disease
• Past history of haemorrhagic stroke
• Thrombocytopaenia (platelets count \< 100 x 109 /L)
• Clinical evidence of portal hypertension
• Known cerebrovascular abnormalities;
• HIV antibody positive;
• Alcohol abuse (\>40 unites/week)
• Menhorragia
• Pregnancy

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

St Mary's Hospital NHS Trust

London, W2 1NY, United Kingdom

Location

Related Links

• Result publication

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Warfarin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Prof Mark Thursz
• Organization: Imperial College London

m.thursz@imperial.ac.uk

+44 (0)20 3312 1903

Study Officials

• Mark R Thursz, MBBS, FRCP

  St Mary's Hospital & Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study employed a single centred, prospective, open labelled design. Practical as well as safety concerns dictated that the study could not be conducted in a blinded fashion, since patients taking anticoagulation require monitoring. The study consisted of two 8 week phases: Phase 1 and Phase 2.

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: August 1, 2005
• Primary Completion: September 1, 2006
• Study Completion: October 1, 2006
• Last Updated: December 1, 2020
• Results First Posted: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)