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

Phase 2

Completed

• Conditions: Bone Marrow Transplantation; Graft Versus Host Disease; Graft-Versus-Host Disease; Graft-Vs-Host Disease

• Registration Number: NCT00189748
• Lead Sponsor: Astellas Pharma Inc

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-19
• Last Update Posted: 2006-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patient had enrolled in GVHD prophylaxis study.
• Patient had been fully informed.

Read More

Exclusion Criteria

• The patient had been not eligible for the administration after 100 days post transplant in the investigator's judgement.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP