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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00451932
First received: March 23, 2007
Last updated: April 15, 2008
Last verified: April 2008

March 23, 2007
April 15, 2008
October 2002
September 2005   (final data collection date for primary outcome measure)
Event rate of biopsy-proven acute rejections
Same as current
Complete list of historical versions of study NCT00451932 on ClinicalTrials.gov Archive Site
Incidence of adverse events
Same as current
Not Provided
Not Provided
 
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Liver Transplantation
Drug: FK778
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
September 2005
September 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Netherlands,   Spain,   Switzerland,   United Kingdom
 
NCT00451932
FG-778-01-100, 8778-CL-1200
Yes
Not Provided
Astellas Pharma Inc
Not Provided
Principal Investigator: Use Central Contact Universitätsklinik Charité
Astellas Pharma Inc
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP