Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX

Liver Transplantation Clinical Trial

— TAST  

Official title:

An Open, Randomized, Multicentre Clinical Study to Compare the Safety and Efficacy of a Combination of Sequential Therapy of Tacrolimus (FK506) With Monoclonal Anti-IL2R Antibodies and Mycophenolate Mofetil Versus Tacrolimus (FK506) With Steroids in Liver Allograft Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693524
• Other study ID #: FG-506-01-IT-01
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2008
• Last updated: August 25, 2014
• Start date: November 2002
• Est. completion date: March 2004

Study information

• Verified date: August 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Study to evaluate the benefits and any risks of the delayed administration of tacrolimus in a combined regimen of mycophenolate mofetil and monoclonal anti-IL2R antibodies (daclizumab), in comparison with a standard steroid + tacrolimus double drug regimen

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is undergoing orthotopic liver allograft transplantation. This includes partial organ transplantation. Age of donor between 5 and 65 years

Exclusion Criteria:

• Patient has previously received or is receiving an organ transplant (including liver re-transplantation)

• Recipient of an auxiliary graft or in which a bio-artificial liver has been used

• Patient is receiving a living related liver transplantation

• Patient is requiring steroids as well as chemotherapy prior to transplantation

• Patient having any previous history of neoplastic disease of any type (including leukaemia). However, patients with primary liver carcinoma can be included if they meet the following criteria:

• > 3 nodes

• No node larger than 5 cm

• No metastases

• No vascular invasion

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• tacrolimus
oral
• Anti-IL2R AB
i.v.
• Mycophenolate mofetil
oral
• prednisone
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of first acute rejection		3 months	Yes
Secondary	Overall frequences of acute rejection episodes		3 months	Yes

External Links

•   Link to Results on JAPIC - enter 140556 in the JapicCTI-RNo. field