Study Details

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A study to compare efficacy and safety of Mycamine® and Itraconazole for preventing fungal infections

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.
NCT00794703

Astellas Study ID

The unique identification code given by the study sponsor.

MCFGCN02-0

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

Fungal Infections in Blood, Fungal Infections

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 Years - 70 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

Nov 2008 - Nov 2009

Masking

None (Open Label)

Enrollment number

288

A multi-center, randomized, open label, parallel study to evaluate and compare the efficacy and safety of Mycamine® vs Itraconazole oral solution for prophylaxis of fungal infections in patients undergoing a hematopoietic stem cell transplant

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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