Study Details

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A Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

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.
NCT03241550

Astellas Study ID

The unique identification code given by the study sponsor.

9766-CL-0046

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

Leukemia

Phase

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

Phase 1

Age

1 years - 17 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 2017 - Jul 2019

Masking

None (Open Label)

Enrollment number

49

A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients

Study summary

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Locations

University of Texas Southwestern Medical Center

Dallas, United States, 75235

Texas Children's Hospital

Houston, United States, 77030

University of California

San Francisco, United States, 94143

University Hospital of Cleveland

Cleveland, United States, 44106

Children’s Mercy Kansas City

Kansas City, United States, 64108

Emory University School of Medicine

Atlanta, United States, 30322

Nicklaus Children's Hospital

Miami, United States, 33155

Children’s of Alabama

Birmingham, United States, 35233

Children’s Hospitals and Clinics of Minnesota

Minneapolis, United States, 55404

University of Louisville

Louisville, United States, 40202

Children’s Hospital of Philadelphia

Philadelphia, United States, 19104

Indiana University School of Medicine

Indianapolis, United States, 46202

SUNY Upstate Medical University

Syracuse, United States, 13210

CHOC Children’s Hospital of Orange County

Orange, United States, 92868

Ann & Robert H Lurie Children’s Hospital of Chicago

Chicago, United States, 60611

Children's Hospital Los Angeles

Los Angeles, United States, 90027

University of California Los Angeles

Los Angeles, United States, 90095

Miller Children's Hospital

Long Beach, United States, 90806

Cincinnati Children’s Hospital Medical Center

Cincinnati, United States, 45229

Duke University Medical Center

Durham, United States, 27710

The Children’s Hospital at TriStar Centennial Medical Center

Nashville, United States, 37203

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