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

Graft Versus Host Disease Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189748
• Other study ID #: FJ-506E-BT02
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: September 19, 2006
• Start date: August 2004

Study information

• Verified date: September 2006
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 54 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Tacrolimus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan,