Hydroxyurea Optimization Through Precision Study (HOPS): A Prospective, Multi-center, Randomized Trial of Personalized, Pharmacokinetics-guided Dosing of Hydroxyurea Versus Standard Weight-based Dosing for Children With Sickle Cell Anemia.

About the study

Hydroxyurea Optimization through Precision Study (HOPS) is a prospective, multi-center,
randomized trial that will directly compare a novel, individualized dosing strategy of
hydroxyurea to standard weight-based dosing for children with SCA. The primary objective of
the study is to evaluate whether a pharmacokinetics-based starting hydroxyurea dose thieves
superior fetal hemoglobin response to to standard weight-based initial dosing. Patients will
be recruited from the pediatric sickle cell clinic at Cincinnati Children’s Hospital Medical
Center and from additional pediatric sickle cell centers within the United States.

Study point of contact

Amanda Pfeiffer
513-803-4977
[email protected]
Patrick McGann, MD
513-803-4991
[email protected]

Locations

13 United States sites

Age

6 to 21 Years

Genotypes

HbSS, SCA

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

participation requirements

– Diagnosis of sickle cell anemia (HbSS, HbSD, HbS/β0-thalassemia, or similarly severe
SCA genotype)

– Age 6 months to 21 years at the time of enrollment

– Clinical decision by patient, family, and healthcare providers to initiate hydroxyurea
therapy

participation restrictions

– Current treatment with chronic, monthly blood transfusions or erythrocytapheresis

– Treatment with hydroxyurea within the past 3 months

– Hemoglobin SC disease, HbS/β+-thalassemia

– Current treatment with other investigational sickle cell medications

– Current known pregnancy or lactation

Locations

  • Atlanta, Georgia, United States, Children's Healthcare of Atlanta, 30342 [Recruiting]
  • Peoria, Illinois, United States, Children's Hospital of Illinois, 61637 [Recruiting]
  • Urbana, Illinois, United States, Carle Foundation Hospital, 61801 [Not yet recruiting]
  • Indianapolis, Indiana, United States, Riley Hospital for Children at Indiana University Health, 46202 [Recruiting]
  • Indianapolis, Indiana, United States, Indiana Hemophilia & Thrombosis Center, Inc. (IHTC), 46260 [Recruiting]
  • Boston, Massachusetts, United States, Boston Children's Hospital, 02215 [Recruiting]
  • Minneapolis, Minnesota, United States, Children's Hospitals and Clinics of Minnesota, 55404 [Recruiting]
  • New Hyde Park, New York, United States, Cohen Children's Medical Center/Northwell Health, 11040 [Recruiting]
  • Cincinnati, Ohio, United States, Cincinnati Children's Hospital Medical Center, 45229 [Recruiting]
  • Cleveland, Ohio, United States, Rainbow Babies / University Hospitals Cleveland Medical Center, 44106 [Recruiting]
  • Cleveland, Ohio, United States, Cleveland Clinic Children's, 44195 [Recruiting]
  • Columbus, Ohio, United States, Nationwide Children's Hospital., 43205 [Recruiting]
  • Milwaukee, Wisconsin, United States, Children's Hospital of Wisconsin, 53226 [Recruiting]
Last updated 2021-03-31