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

Phase 2

Completed

• Conditions: Bone Marrow Transplantation; Graft Versus Host Disease; Graft-Vs-Host Disease; Graft-Versus-Host Disease

• Registration Number: NCT00189761
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-19
• Last Update Posted: 2006-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP