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

September 19, 2006 updated by: Astellas Pharma Inc

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).

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu region, Japan
      • Hokkaido region, Japan
      • Kanto region, Japan
      • Kyusyu region, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Chair: Clinical development, Astellas Pharma Inc., Japan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 20, 2006

Last Update Submitted That Met QC Criteria

September 19, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJ-506E-BT02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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