A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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