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NCT00189761 Clinical Trial

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

Graft Versus Host Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189761
Other study ID # FJ-506E-BT01
Secondary ID
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated September 19, 2006

Study information
Verified date September 2006
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Health, Labor and Welfare
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 54 Years
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Tacrolimus

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

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