Study Details

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An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

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.
NCT00818584

Astellas Study ID

The unique identification code given by the study sponsor.

9463-CL-2104

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

Infections

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

48 Hours - 120 Days

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 2007 - Oct 2007

Masking

None (Open Label)

Enrollment number

13

A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

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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