Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.
Eligibility Criteria
Inclusion
- Male or female patients at least 18 years of age and not older than 65 years.
- Female patients of child bearing potential must have a negative serum pregnancy test prior to enrollment and must agree to practice effective birth control during the study.
- Male patients must agree to practice effective birth control methods during the study.
- Patient is a recipient of a primary whole cadaveric liver transplant
Exclusion
- Patient has previously received or is receiving an organ transplant other than a liver.
- Patient has received an ABO incompatible donor liver.
- Patient or donor is known to be HIV positive.
- Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- Patient is being transplanted for hepatic malignancy with a single nodule greater than 5.0 cm in diameter or 2 or more nodules with at least one \> 3.0 cm.
- Patient has a serum creatinine \>175 µmol/L at baseline. Patient has uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with the study objectives.
- Patient who is receiving or may require warfarin or fluvastatin during the study.
- Patient is participating in another clinical trial and/or is taking or has been taking an investigational drug in the 28 days prior to transplant
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00451932
Start Date
October 1 2002
End Date
September 1 2005
Last Update
April 17 2008
Active Locations (29)
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1
Innsbruck, Austria
2
Brussels, Belgium
3
Leuven, Belgium
4
Edmonton, Alberta, Canada