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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00451932 |
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Date of registration:
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23/03/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients
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Scientific title:
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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 |
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Date of first enrolment:
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October 2002 |
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Target sample size:
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303 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00451932 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Belgium
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Canada
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Czech Republic
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France
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Germany
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Hungary
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Italy
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Netherlands
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Spain
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Switzerland
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United Kingdom
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Contacts
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Name:
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Use Central Contact |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universitätsklinik Charité |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Liver Transplantation
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Intervention(s)
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Drug: FK778
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Primary Outcome(s)
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Event rate of biopsy-proven acute rejections
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Secondary Outcome(s)
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Incidence of adverse events
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Secondary ID(s)
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FG-778-01-100
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8778-CL-1200
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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