Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care



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Therapuetic Areas:Cardiology / Vascular Diseases, Dermatology / Plastic Surgery, Endocrinology, Gastroenterology, Hematology, Immunology / Infectious Diseases, Musculoskeletal, Nephrology / Urology, Neurology, Ophthalmology, Otolaryngology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Other
Healthy:No
Age Range:Any - 21
Updated:4/6/2019
Start Date:November 2011
End Date:February 2020
Contact:Barrie Harper, MT (ASCP), PMP
Email:barrie.harper@duke.edu
Phone:919-668-8291

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Trial Summary
Trial Overview
Inclusion Criteria
Understudied drugs will be administered to children per standard of care as prescribed by
their treating caregiver and only biological sample collection during the time of drug
administration will be involved. A total of approximately 7000 children aged <21 years who
are receiving these drugs for standard of care will be enrolled and will be followed for up a
maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of
understudied drugs for which specific dosing recommendations and safety data are lacking. The
prescribing of drugs to children will not be part of this protocol. Taking advantage of
procedures done as part of routine medical care (i.e. blood draws) this study will serve as a
tool to better understand drug exposure in children receiving these drugs per standard of
care. The data collected through this initiative will also provide valuable pharmacokinetic
and dosing information of drugs in different pediatric age groups as well as special
pediatric populations (i.e. obese).

The purpose of this study is to characterize the PK ( Pharmacokinetics) of understudied drugs
administered to children per standard of care as prescribed by their treating caregiver. This
will be accomplished by the collection of biological samples during the time of drug
administration per standard of care as prescribed by the caregiver. The prescribing of drugs
to children will not be part of this protocol.

Aim #1: Evaluate the PK of understudied drugs currently being administered to children.

Hypothesis #1: The PK of understudied drugs in children will differ from adults and within
children according to pediatric age groups or special population.

Aim #2: Explore the pharmacodynamics (PD) of understudied drugs currently being administered
to children.

Hypothesis #2: The PD of targeted drugs in children will differ from adults.

Aim #3: Evaluate the influence of genetic factors, metabolic and protein profiles on
therapeutic exposure.

Hypothesis #3: Genetic polymorphisms in drug metabolizing enzymes and metabolic and proteomic
profiles will impact drug exposure in children.

Inclusion Criteria:

- 1) Children (< 21 years of age) who are receiving understudied drugs of interest per
standard of care as prescribed by their treating caregiver

Exclusion Criteria:

- 1) Failure to obtain consent/assent (as indicated)

- 2) Known pregnancy as determined via interview or testing if available.
We found this trial at
47
sites
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108
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Cincinnati Children's Hospital Medical Center
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Stuart Goldstein, MD
Phone: 513-803-5332
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Cincinnati, OH
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Rainbow Babies and Children's Hospital
11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: David Speicher, MD
Phone: 216-844-5112
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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Cleveland, OH
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University of Mississippi Medical Center
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Jospeh Majure
Phone: 601-815-4517
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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Oregon Health and Science University
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Amira Al-Uzri, MD
Phone: 503-418-8112
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Rhode Island Hospital
593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Principal Investigator: Margaret Scheffler
Phone: 401-444-2884
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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from
Providence, RI
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Alfred I. duPont Hospital for Children
1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Principal Investigator: Marisa Meyer, MD
Phone: 302-651-7521
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Wilmington, DE
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University of New Mexico Health Sciences Center
Albuquerque, New Mexico 87131
Principal Investigator: Hengameh Raissy
Phone: 505-272-9898
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Albuquerque, NM
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Alaska Native Medical Center
Anchorage, Alaska
Principal Investigator: Rosalyn Singleton
Phone: 907-729-2987
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Anchorage, AK
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Children's Hospital Colorado
13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Peter Mourani, MD
Phone: 720-777-5380
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Aurora, CO
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University of Maryland
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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Boston Children's Hospital
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Principal Investigator: Vivian Nasr, MD
Phone: 857-218-5348
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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Boston, MA
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University of Vermont Medical Center
Burlington, Vermont 05405
Principal Investigator: Kelly Cowan
Phone: 802-656-9401
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Burlington, VT
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UNC Hospital Neonatal-Perinatal Medicine
Chapel Hill, North Carolina 27599
Principal Investigator: Matthew Laughon, MD, MPH
Phone: 984-974-7865
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Chapel Hill, NC
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Andrew Atz, MD
Phone: 843-792-5309
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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University of Virginia Children's Hospital
Charlottesville, Virginia 22908
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Charlottesville, VA
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Lurie Children's Hospital- Chicago
Chicago, Illinois 60614
Principal Investigator: William Muller, MD
Phone: 312-227-6285
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Chicago, IL
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Akron Children's Hospital
Cleveland, Ohio 44313
Principal Investigator: Martha Blackford, PharmD
Phone: 330-543-0731
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Cleveland, OH
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University of South Carolina
Columbia, South Carolina 29208
Principal Investigator: Lisa Knight
Phone: 803-434-4986
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Columbia, SC
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Children's Hospital of Michigan
3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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Duke University Medical Center (PICU / NICU)
2301 Erwin Road
Durham, North Carolina 27710
Principal Investigator: Hornik Chi, PharmD
Phone: 919-668-3910
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Durham, NC
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University of Kansas Medical Center
Fairway, Kansas 66205
Principal Investigator: Pahud Barbara, MD
Phone: 816-960-3007
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Fairway, KS
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Kapiolani Womens and Childrens Medical Center
1319 Punahou Street
Honolulu, Hawaii 96826
Principal Investigator: Annette Amiotte
Phone: 808-369-1247
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Honolulu, HI
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Riley Hospital for Children, Indiana University
Indianapolis, Indiana 46202
Principal Investigator: Gregory Sokol, MD,
Phone: 317-274-4708
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Indianapolis, IN
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University of Florida Jacksonville Shands Medical Center
Jacksonville, Florida 32209
Principal Investigator: Mobeen Rathore, MD
Phone: 904-244-2266
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Jacksonville, FL
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Children's Mercy Hospital and Clinics
Kansas City, Kansas 66160
Principal Investigator: Pahud Barbara, MD
Phone: 816-960-3007
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Kansas City, KS
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University of California, San Diego Medical Center
La Jolla, California 92093
Principal Investigator: Adriana Tremoulet, MD
Phone: 858-246-0012
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La Jolla, CA
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Dartmouth Hitchcock Medical Center
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Paul Palumbo
Phone: 603-653-9064
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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Arkansas Children's Hospital
1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: Laura James, MD
Phone: 501-364-6990
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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Little Rock, AR
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Axis Clinical Trials
Los Angeles, California 90036
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Los Angeles, CA
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University of California Los Angeles Medical Center
Los Angeles, California 90024
Principal Investigator: Jaime Deville, MD
Phone: 310-206-2439
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Los Angeles, CA
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Norton Children's Hospital
Louisville, Kentucky 40202
Principal Investigator: Janice Sullivan, MD, FAAP, FCCM, CPI, CIP
Phone: 502-629-4698
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Louisville, KY
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Medical College of Wisconsin
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Principal Investigator: Nathan Thompson, MD
Phone: 414-955-2846
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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University of Montana
Missoula, Montana 59812
Principal Investigator: Paul Smith
Phone: 406-370-7379
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Missoula, MT
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West Virginia University Hospital
Morgantown, West Virginia
Principal Investigator: Lee Pyles
Phone: 304-293-2081
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Morgantown, WV
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Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
Principal Investigator: Jorn-Hendrik Weitkamp, MD
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Nashville, TN
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Yale-New Haven Children's Hospital
New Haven, Connecticut 06511
Principal Investigator: Matthew Bizzarro, MD
Phone: 203-688-2320
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New Haven, CT
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Tulane University Health Science Center
New Orleans, Louisiana 70112
Principal Investigator: Stacy Drury
Phone: 504-988-1438
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New Orleans, LA
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Ochsner Baptist Clinical Trials Unit
New Orleans, Louisiana 70115
Principal Investigator: Amanda England, MD
Phone: 504-894-2861
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New Orleans, LA
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Kravis Children's Hospital at Mt. Sinai
New York, New York 10029
Principal Investigator: George Ofori-Amanfo, MD
Phone: 212-241-6489
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New York, NY
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The Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma 73104
Principal Investigator: Christine Allen, MD
Phone: 405-271-4407
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Oklahoma City, OK
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Univ of Nebraska Med Ctr
Emile St
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: McCulloh Russell, MD
Phone: 402-552-9878
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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Kids Research Institute
9 High Street
Randwick, New South Wales 2750
Principal Investigator: Chris Cowell, MD
Phone: 011-02-9845-0364
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Randwick,
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University of Utah Hospitals and Clinics
Salt Lake City, Utah 84132
Principal Investigator: Catherine Sherwin, MD
Phone: 801-587-7525
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Salt Lake City, UT
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Seattle Children's Hospital
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Principal Investigator: Joseph Flynn, MD
Phone: 206-884-1422
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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Childrens National Medical Center
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: John van den Anker, MD, PhD, FAAP, FCP
Phone: 202-476-2245
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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Washington,
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Wesley Medical Center
550 N Hillside St
Wichita, Kansas 67214
(316) 962-2000
Principal Investigator: Paula Delmore, MSN
Phone: 316-962-8580
Wesley Medical Center Welcome to one of the most experienced and comprehensive medical centers in...
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Wichita, KS
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