Back to resultsA Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
Primary Purpose
Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Vs-Host Disease
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Bone Marrow Transplantation focused on measuring Tacrolimus, Immunosuppression, Bone Marrow Transplantation, Graft versus Host Disease
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00189761
First Posted
September 13, 2005
Last Updated
September 19, 2006
Sponsor
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT00189761
Brief Title
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
5. Study Description
Brief Summary
A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Vs-Host Disease, Graft-Versus-Host Disease
Keywords
Tacrolimus, Immunosuppression, Bone Marrow Transplantation, Graft versus Host Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical development
Organizational Affiliation
Astellas Pharma Inc., Japan
Official's Role
Study Chair
Facility Information:
City
Chubu region
Country
Japan
City
Hokkaido region
Country
Japan
City
Kanto region
Country
Japan
City
Kyusyu region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
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