Hydroxyurea Optimization Through Precision Study

PHASE3CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

January 17, 2019

Primary Completion Date

March 19, 2025

Study Completion Date

March 19, 2025

Conditions
Sickle Cell DiseaseSickle Cell Anemia
Interventions
DRUG

Hydroxyurea

The alternative arm will use PK data to choose a starting hydroxyurea dose to achieve an AUC of 115 mg\*h/L to approximate maximum tolerated dose. On the standard arm, participants will start at the traditional, weight-based dose of 20 mg/kg/day. Following selection of the starting dose, all participants will follow the same dose escalation and laboratory monitoring procedures.

Trial Locations (13)

11040

Cohen Children's Medical Center/Northwell Health, New Hyde Park

30342

Children's Healthcare of Atlanta, Atlanta

43205

Nationwide Children's Hospital., Columbus

44106

Rainbow Babies / University Hospitals Cleveland Medical Center, Cleveland

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children at Indiana University Health, Indianapolis

46260

Indiana Hemophilia & Thrombosis Center, Inc. (IHTC), Indianapolis

53226

Children's Hospital of Wisconsin, Milwaukee

55404

Children's Hospitals and Clinics of Minnesota, Minneapolis

61637

Children's Hospital of Illinois, Peoria

61801

Carle Foundation Hospital, Urbana

85016

Phoenix Children's Hospital, Phoenix

02215

Boston Children's Hospital, Boston

All Listed Sponsors
collaborator

Doris Duke Charitable Foundation

OTHER

lead

Lifespan

OTHER

NCT03789591 - Hydroxyurea Optimization Through Precision Study | Biotech Hunter | Biotech Hunter