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

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)

Completed

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Key information

Conditions

Bone Marrow Transplantation Graft Versus Host Disease Graft vs Host Disease Graft-Versus-Host Disease Graft-vs-Host Disease Immune System Diseases

Age range

20 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chubu Region, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus

Drug

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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).

Important dates

Study start: 2004
First posted: Sep 19, 2005
Registry last updated: Sep 20, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed