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OpenTrials
Completed

NCT Number: NCT00693524

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

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

Completed

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

Drug

oral

Other names: FK506, Prograf

Anti-IL2R AB

Drug

i.v.

Other names: daclizumab

Mycophenolate mofetil

Drug

oral

Prednisone

Drug

oral

Other names: steroid

Primary outcomes

  1. Incidence of first acute rejection

    Time frame: 3 months

Secondary outcomes

  1. Overall frequences of acute rejection episodes

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Acronym: TAST

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jun 9, 2008
Registry last updated
Aug 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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