NCT00189748

Brief Summary

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)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

September 20, 2006

Status Verified

September 1, 2006

First QC Date

September 13, 2005

Last Update Submit

September 19, 2006

Conditions

Bone Marrow TransplantationGraft Versus Host DiseaseGraft-Versus-Host DiseaseGraft-Vs-Host Disease

Keywords

TacrolimusImmunosuppressionBone Marrow TransplantationGraft versus Host Disease

Interventions

TacrolimusDRUG

Eligibility Criteria

Age20 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Chubu Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyusyu Region, Japan

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Clinical development

    Astellas Pharma Inc., Japan

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

August 1, 2004

Last Updated

September 20, 2006

Record last verified: 2006-09

Locations

JP(4)