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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189761
First Posted: September 19, 2005
Last Update Posted: September 20, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Astellas Pharma Inc
September 13, 2005
September 19, 2005
September 20, 2006
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Complete list of historical versions of study NCT00189761 on ClinicalTrials.gov Archive Site
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A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
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
A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients
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Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bone Marrow Transplantation
  • Graft Versus Host Disease
  • Graft-Vs-Host Disease
  • Graft-Versus-Host Disease
Drug: Tacrolimus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Sexes Eligible for Study: All
20 Years to 54 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00189761
FJ-506E-BT01
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Astellas Pharma Inc
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Study Chair: Clinical development Astellas Pharma Inc., Japan
Astellas Pharma Inc
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP