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

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00451932
• Other study ID #: FG-778-01-100
• Secondary ID: 8778-CL-1200
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2007
• Last updated: April 15, 2008
• Start date: October 2002
• Est. completion date: September 2005

Study information

• Verified date: April 2008
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Czech Republic: State Institute for Drug ControlUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySweden: Medical Products AgencyItaly: Ministry of HealthSwitzerland: SwissmedicAustria: Federal Ministry for Health and WomenCanada: Health CanadaPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• FK778

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event rate of biopsy-proven acute rejections
Secondary	Incidence of adverse events