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

NCT ID: NCT00189761

Last Updated: 2006-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Bone Marrow Transplantation Graft Versus Host Disease Graft-Vs-Host Disease Graft-Versus-Host Disease

Keywords

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Tacrolimus Immunosuppression Bone Marrow Transplantation Graft versus Host Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tacrolimus

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Clinical development

Role: STUDY_CHAIR

Astellas Pharma Inc., Japan

Locations

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Chubu Region, , Japan

Site Status

Hokkaido Region, , Japan

Site Status

Kanto Region, , Japan

Site Status

Kyusyu Region, , Japan

Site Status

Countries

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Japan

Other Identifiers

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FJ-506E-BT01

Identifier Type: -

Identifier Source: org_study_id