Back to resultsA Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-
Primary Purpose
Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Versus-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: Patient had enrolled in GVHD prophylaxis study. Patient had been fully informed. Exclusion Criteria: The patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00189748
First Posted
September 13, 2005
Last Updated
September 19, 2006
Sponsor
Astellas Pharma Inc
1. Study Identification
Unique Protocol Identification Number
NCT00189748
Brief Title
A Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-
Official Title
An Extension Study of the Patients Enrolled in Acute Graft Versus Host Disease (GVHD) Prophylaxis Study (Protocol No. FJ-506E-BT01) to Assess Safety and Efficacy of GVHD Prophylaxis of a Tacrolimus New Oral Formulation (MR4).
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
5. Study Description
Brief Summary
To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who are eligible for the administration after 100 days post transplant (up to 1 year)
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-Versus-Host Disease, Graft-Vs-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:
Patient had enrolled in GVHD prophylaxis study.
Patient had been fully informed.
Exclusion Criteria:
The patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.
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 the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-
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