ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients

This study has been completed.

Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00189761
  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 II

MedlinePlus related topics:   Bone Marrow Transplantation   

ChemIDplus related topics:   Tacrolimus    Tacrolimus anhydrous   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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
  Eligibility
Ages Eligible for Study:   20 Years to 54 Years
Genders Eligible for Study:   Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189761

Locations
Japan
      Hokkaido region, Japan
      Kanto region, Japan
      Chubu region, Japan
      Kyusyu region, Japan

Sponsors and Collaborators
Astellas Pharma Inc

Investigators
Study Chair:     Clinical development     Astellas Pharma Inc., Japan    
  More Information


Study ID Numbers:   FJ-506E-BT01
First Received:   September 13, 2005
Last Updated:   September 19, 2006
ClinicalTrials.gov Identifier:   NCT00189761
Health Authority:   Japan: Ministry of Health, Labor and Welfare

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

Study placed in the following topic categories:
Graft versus host disease
Graft vs Host Disease
Tacrolimus
Homologous wasting disease

Additional relevant MeSH terms:
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2008

U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act
U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services



Links to all studies - primarily for crawlers