Status:
COMPLETED
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Bone Marrow Transplantation
Graft Versus Host Disease
Eligibility:
All Genders
20-54 years
Phase:
PHASE2
Brief Summary
A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients
Eligibility Criteria
Inclusion
- Bone marrow transplantation patients aged 20-54 except for transplanted from genetically HLA matched sibling donor.
- The patient had been fully informed.
Exclusion
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00189761
Last Update
September 20 2006
Active Locations (4)
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1
Chubu Region, Japan
2
Hokkaido Region, Japan
3
Kanto Region, Japan
4
Kyusyu Region, Japan