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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00451932
Recruitment Status : Completed
First Posted : March 26, 2007
Last Update Posted : April 17, 2008
Sponsor:
Information provided by:
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: FK778 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : October 2002
Primary Completion Date : September 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Incidence of adverse events


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00451932


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

ClinicalTrials.gov Identifier: NCT00451932     History of Changes
Other Study ID Numbers: FG-778-01-100
8778-CL-1200
First Posted: March 26, 2007    Key Record Dates
Last Update Posted: April 17, 2008
Last Verified: April 2008

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