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
  Purpose

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


Condition Intervention Phase
Liver Transplantation
Drug: FK778
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Event rate of biopsy-proven acute rejections

Secondary Outcome Measures:
  • Incidence of adverse events

Enrollment: 303
Study Start Date: October 2002
Study Completion Date: September 2005
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451932

  Show 30 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Principal Investigator: Use Central Contact Universitätsklinik Charité
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00451932     History of Changes
Other Study ID Numbers: FG-778-01-100, 8778-CL-1200
Study First Received: March 23, 2007
Last Updated: April 15, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Czech Republic: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency
Italy: Ministry of Health
Switzerland: Swissmedic
Austria: Federal Ministry for Health and Women
Canada: Health Canada
Poland: Ministry of Health

Keywords provided by Astellas Pharma Inc:
Malononitrilamide
Immunosuppression
treatment efficacy
treatment effectiveness

ClinicalTrials.gov processed this record on October 23, 2014