A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
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
1 other identifier
interventional
N/A
1 country
4
Brief Summary
A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedSeptember 20, 2006
September 1, 2006
September 13, 2005
September 19, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Bone marrow transplantation patients aged 20-54 except for transplanted from genetically HLA matched sibling donor.
- The patient had been fully informed.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Chubu Region, Japan
Unknown Facility
Hokkaido Region, Japan
Unknown Facility
Kanto Region, Japan
Unknown Facility
Kyusyu Region, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Clinical development
Astellas Pharma Inc., Japan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Last Updated
September 20, 2006
Record last verified: 2006-09