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

Astellas

Status and phase: Completed; Phase 2

Conditions: Liver Transplantation

Treatments: Drug: Mycophenolate mofetil; Drug: tacrolimus; Drug: Anti-IL2R AB; Drug: prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00693524

FG-506-01-IT-01

Details and patient eligibility

About

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

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

1

Experimental group

Description:

Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil

Treatment:

Drug: Anti-IL2R AB

Drug: tacrolimus

Drug: Mycophenolate mofetil

2

Active Comparator group

Description:

Tacrolimus + Steroid

Treatment:

Drug: prednisone

Drug: tacrolimus