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

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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)

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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