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

This study has been completed.

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00189748

Purpose

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)

Condition	Intervention	Phase
Bone Marrow Transplantation Graft Versus Host Disease Graft-Versus-Host Disease Graft-Vs-Host Disease	Drug: Tacrolimus	Phase II

MedlinePlus related topics: Bone Marrow Transplantation

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Extension Study of the Patients Enrolled in Acute Graft Versus Host Disease (GVHD) Prophylaxis Study (Protocol No. FJ-506E-BT01) to Assess Safety and Efficacy of GVHD Prophylaxis of a Tacrolimus New Oral Formulation (MR4).

Further study details as provided by Astellas Pharma Inc:

Study Start Date:

August 2004

Eligibility

Ages Eligible for Study:	20 Years to 54 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189748

Locations

Japan

Hokkaido region, Japan

Kanto region, Japan

Chubu region, Japan

Kyusyu region, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Clinical development

Astellas Pharma Inc., Japan

More Information

Study ID Numbers:	FJ-506E-BT02
Study First Received:	September 13, 2005
Last Updated:	September 19, 2006
ClinicalTrials.gov Identifier:	NCT00189748
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

Tacrolimus
Immunosuppression
Bone Marrow Transplantation
Graft versus Host Disease

Study placed in the following topic categories:

Graft versus host disease
Graft vs Host Disease
Tacrolimus
Homologous wasting disease

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009