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Clinical Trials/NCT00189761
NCT00189761
Completed
Phase 2

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

Astellas Pharma Inc0 sitesStarted: September 19, 2005Last updated:
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ConditionsBone Marrow TransplantationGraft Versus Host DiseaseGraft-Vs-Host DiseaseGraft-Versus-Host Disease
DrugsTacrolimus

Overview

Phase
Phase 2
Status
Completed
OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 54 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Investigators

Sponsor Class
Industry

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