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Sponsored by: |
Astellas Pharma Inc |
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Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00451932 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
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) |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Use Central Contact | Universitätsklinik Charité |
Study ID Numbers: | FG-778-01-100, 8778-CL-1200 |
Study First Received: | March 23, 2007 |
Last Updated: | April 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00451932 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; France: Afssaps - French Health Products Safety Agency; 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 |
Malononitrilamide Immunosuppression treatment efficacy treatment effectiveness |
Tacrolimus |