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

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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00189748

Enrollment

Unknown

Registered

2005-09-19

Start date

2004-08-31

Completion date

Unknown

Last updated

2006-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Marrow Transplantation, Graft Versus Host Disease, Graft-Versus-Host Disease, Graft-Vs-Host Disease

Keywords

Tacrolimus, Immunosuppression, Bone Marrow Transplantation, Graft versus Host Disease

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)

Interventions

DRUGTacrolimus

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 54 Years

Healthy volunteers

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.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026