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

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

Official Title
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A Multicentre, Randomised, Double-Blind, Tacrolimus Dual Therapy-Controlled, Parallel Group, Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of FK778 in Liver Transplant Patients Receiving Standard Tacrolimus (FK506) and Steroids Therapy

Conditions
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Liver Transplantation

Intervention / Treatment
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* Drug: FK778


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: FK778|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event rate of biopsy-proven acute rejections |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malononitrilamide, Immunosuppression, treatment efficacy, treatment effectiveness