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

This study has been completed.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00189761
First received: September 13, 2005
Last updated: September 19, 2006
Last verified: September 2006
  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
Endpoint Classification: Safety/Efficacy Study
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:

  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
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

No publications provided

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

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014