Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by:
Astellas Pharma Inc Identifier:
First received: September 13, 2005
Last updated: September 19, 2006
Last verified: September 2006
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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Study Start Date: August 2004

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00189748

Chubu region, Japan
Hokkaido region, Japan
Kanto region, Japan
Kyusyu region, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Clinical development Astellas Pharma Inc., Japan
  More Information Identifier: NCT00189748     History of Changes
Other Study ID Numbers: FJ-506E-BT02 
Study First Received: September 13, 2005
Last Updated: September 19, 2006
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:
Bone Marrow Transplantation
Graft versus Host Disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 26, 2016