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

Astellas

Status and phase: Completed; Phase 2

Conditions: Graft Versus Host Disease; Graft-Versus-Host Disease; Graft-Vs-Host Disease; Bone Marrow Transplantation

Treatments: Drug: Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189748

FJ-506E-BT02

Details and patient eligibility

About

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)

Sex: All

Ages: 20 to 54 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)