Study Details

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Study of Mycamine® in children with fungal infections to evaluate safety and blood levels of the drug

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.
NCT00608335

Astellas Study ID

The unique identification code given by the study sponsor.

9463-CL-2101

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

Candida Fungal Infection, Infections, Fungal Infections

Phase

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

Phase 1

Age

2 years - 16 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

Oct 2007 - Sep 2011

Masking

None (Open Label)

Enrollment number

84

A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Children (2-5 Years AND 6-11 Years) And Adolescents (12-16 Years) With Esophageal Candidiasis Or Other Invasive Candidiasis

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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Locations

Grootte Schuur Hospital

Cape Town, South Africa, 7924

2 Military Hospital

Wynberg, South Africa, 7824

Children’s Mercy Hospital

Kansas City, United States, 64108

Oregon Health and Science University

Portland, United States, 97239

Jubilee Hospital

Temba, South Africa, 0400

University of Texas Southwestern

Dallas, United States, 75390

Texas Children's Hospital

Houston, United States, 77030

Benmed Park Clinic

Benoni, South Africa, 1500

St. Mary's Hospital

Mariannhill, South Africa, 3610

University of Minnesota

Minneapolis, United States, 55455

GCT -Sunnyside Medi-clinic

Lynn East, South Africa, 0039

University of California Los Angeles Medical Center

Los Angeles, United States, 90095

Duke University Medical Center

Durham, United States, 27710

Children's Hospital of Orange County

Orange, United States, 92868

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