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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Study Completion Date

2004-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Tacrolimus + Anti-IL2R AB + Mycophenolate mofetil

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

oral

Anti-IL2R AB

Intervention Type DRUG

i.v.

Mycophenolate mofetil

Intervention Type DRUG

oral

2

Tacrolimus + Steroid

Group Type ACTIVE_COMPARATOR

tacrolimus

Intervention Type DRUG

oral

prednisone

Intervention Type DRUG

oral

Interventions

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tacrolimus

oral

Intervention Type DRUG

Anti-IL2R AB

i.v.

Intervention Type DRUG

Mycophenolate mofetil

oral

Intervention Type DRUG

prednisone

oral

Intervention Type DRUG

Other Intervention Names

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FK506 Prograf daclizumab steroid

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No