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A study to assess the safety and efficacy of a tacrolimus new oral formulation (MR4) in BMT patients-Extension-

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT00189748

Astellas Study ID

The unique identification code given by the study sponsor.

FJ-506E-BT02

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Follow Trial

Condition

Bone Marrow Transplant, Transplant Rejection

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

20 Years - 54 Years

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Aug 2004 - Jan 1970

Masking

None (Open Label)

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).

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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