Status:

COMPLETED

A Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-

Lead Sponsor:

Astellas Pharma Inc

Conditions:

Bone Marrow Transplantation

Graft Versus Host Disease

Eligibility:

All Genders

20-54 years

Phase:

PHASE2

Brief Summary

To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who are eligible for the administration after 100 days post transplant (up to 1 year)

Eligibility Criteria

Inclusion

  • Patient had enrolled in GVHD prophylaxis study.
  • Patient had been fully informed.

Exclusion

  • The patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.

Key Trial Info

Start Date :

August 1 2004

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00189748

Start Date

August 1 2004

Last Update

September 20 2006

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Chubu Region, Japan

2

Hokkaido Region, Japan

3

Kanto Region, Japan

4

Kyusyu Region, Japan