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A Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-

NCT ID: NCT00189748

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

Study Start Date

2004-08-31

Brief Summary

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To assess safety and efficacy of the patients with MR4 therapy in GVHD prophylaxis study who are eligible for the administration after 100 days post transplant (up to 1 year)

Detailed Description

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Conditions

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

* Patient had enrolled in GVHD prophylaxis study.
* Patient had been fully informed.

Exclusion Criteria

* The patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.
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-BT02

Identifier Type: -

Identifier Source: org_study_id