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

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: September 13, 2005
Last updated: September 19, 2006
Last verified: September 2006
A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients

Condition Intervention Phase
Bone Marrow Transplantation
Graft Versus Host Disease
Graft-Vs-Host Disease
Graft-Versus-Host Disease
Drug: Tacrolimus
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Multi-Center Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in De Novo Bone Marrow Transplant Recipients

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:


Ages Eligible for Study:   20 Years to 54 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00189761

Chubu region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kyusyu region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Clinical development Astellas Pharma Inc., Japan
  More Information Identifier: NCT00189761     History of Changes
Other Study ID Numbers: FJ-506E-BT01
Study First Received: September 13, 2005
Last Updated: September 19, 2006

Keywords provided by Astellas Pharma Inc:
Bone Marrow Transplantation
Graft versus Host Disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017