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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00451932

Enrollment

303

Registered

2007-03-26

Start date

2002-10-31

Completion date

2005-09-30

Last updated

2008-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Keywords

Malononitrilamide, Immunosuppression, treatment efficacy, treatment effectiveness

Brief summary

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

Interventions

DRUGFK778

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Event rate of biopsy-proven acute rejections	—

Secondary

Measure	Time frame
Incidence of adverse events	—

Countries

Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Italy, Netherlands, Spain, Switzerland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026