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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00693524
First received: June 4, 2008
Last updated: July 9, 2008
Last verified: July 2008

June 4, 2008
July 9, 2008
November 2002
March 2004   (final data collection date for primary outcome measure)
Incidence of first acute rejection [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00693524 on ClinicalTrials.gov Archive Site
Overall frequences of acute rejection episodes [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Sequential Therapy (FK506 + Monoclonal Anti-IL2R Antibodies + MMF) Versus FK506 With Steroids in Liver TX
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Transplantation
  • Drug: tacrolimus
    oral
    Other Names:
    • FK506
    • Prograf
  • Drug: Anti-IL2R AB
    i.v.
    Other Name: daclizumab
  • Drug: Mycophenolate mofetil
    oral
  • Drug: prednisone
    oral
    Other Name: steroid
  • Experimental: 1
    Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil
    Interventions:
    • Drug: tacrolimus
    • Drug: Anti-IL2R AB
    • Drug: Mycophenolate mofetil
  • Active Comparator: 2
    Tacrolimus + Steroid
    Interventions:
    • Drug: tacrolimus
    • Drug: prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
March 2004
March 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00693524
FG-506-01-IT-01
No
Disclosure Office Europe, Astellas Pharma Europe BV
Astellas Pharma Inc
Not Provided
Study Director: Central Contact Astellas Pharma Europe B.V.
Astellas Pharma Inc
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP