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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
  Purpose
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: None (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:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189761


Locations
Japan
Chubu region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kyusyu region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Clinical development Astellas Pharma Inc., Japan
  More Information

ClinicalTrials.gov Identifier: NCT00189761     History of Changes
Other Study ID Numbers: FJ-506E-BT01
First Submitted: September 13, 2005
First Posted: September 19, 2005
Last Update Posted: September 20, 2006
Last Verified: September 2006

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

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action