Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-29 @ 5:32 AM
Study NCT ID:
NCT00451932
Status:
COMPLETED
Last Update Posted:
2008-04-17
First Post:
2007-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients
Sponsor:
Organization:
Raw JSON
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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.\n* Patient who is receiving or may require warfarin or fluvastatin during the study.\n* 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'}, 'identificationModule': {'nctId': 'NCT00451932', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'FG-778-01-100'}, 'secondaryIdInfos': [{'id': '8778-CL-1200'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'FK778', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Innsbruck', 'country': 'Austria', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Leuven', 'country': 'Belgium', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Clichy', 'country': 'France', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Montpellier', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Rennes', 'country': 'France', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Villejuif', 'country': 'France', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Essen', 'country': 'Germany', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Hamburg', 'country': 'Germany', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Hanover', 'country': 'Germany', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Udine', 'country': 'Italy', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Barakaldo', 'country': 'Spain', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Santiago de Compostela', 'country': 'Spain', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'city': 'Zurich', 'country': 'Switzerland', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'London', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsklinik Charité'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}}}}