A Study to Assess the Safety and Efficacy of a Tacrolimus New Oral Formulation (MR4) in BMT Patients-Extension-
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00189748
First received: September 13, 2005
Last updated: September 19, 2006
Last verified: September 2006
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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)
Condition | Intervention | Phase |
---|---|---|
Bone Marrow Transplantation Graft Versus Host Disease Graft-Versus-Host Disease Graft-Vs-Host Disease |
Drug: Tacrolimus |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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). |
Resource links provided by NLM:
MedlinePlus related topics:
Bone Marrow Transplantation
Drug Information available for:
Tacrolimus
U.S. FDA Resources
Further study details as provided by Astellas Pharma Inc:
Eligibility
Ages Eligible for Study: | 20 Years to 54 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
More Information
No publications provided
Keywords provided by Astellas Pharma Inc:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 16, 2012
No publications provided
ClinicalTrials.gov Identifier: | NCT00189748 History of Changes |
Other Study ID Numbers: | FJ-506E-BT02 |
Study First Received: | September 13, 2005 |
Last Updated: | September 19, 2006 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Astellas Pharma Inc:
Tacrolimus Immunosuppression Bone Marrow Transplantation Graft versus Host Disease |
Additional relevant MeSH terms:
Graft vs Host Disease Immune System Diseases Tacrolimus Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on October 16, 2012