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

Astellas

Status and phase

Completed

Phase 2

Conditions

Liver Transplantation

Treatments

Drug: FK778

Study type

Interventional

Funder types

Industry

Identifiers

FG-778-01-100

8778-CL-1200

Details and patient eligibility

About

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

Enrollment

303 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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