A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients

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

NCT00189761

FJ-506E-BT01

Details and patient eligibility

About

A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients

Sex: All

Ages: 20 to 54 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bone marrow transplantation patients aged 20-54 except for transplanted from genetically HLA matched sibling donor.
• The patient had been fully informed.

Exclusion criteria

• The patient had severe impaired hepatic function.
• The patient had impaired renal function.
• The patient had existing complication of severe cardiac dysfunction.
• The patient had severe impaired pulmonary function.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)