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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

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.