Hydroxyurea Optimization Through Precision Study

Description

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.

Conditions

Sickle Cell Disease, Sickle Cell Anemia

Study Overview

Study Details

Study overview

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.

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.

Hydroxyurea Optimization Through Precision Study

Condition
Sickle Cell Disease
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Atlanta

Children's Healthcare of Atlanta, Atlanta, Georgia, United States, 30342

Peoria

Children's Hospital of Illinois, Peoria, Illinois, United States, 61637

Urbana

Carle Foundation Hospital, Urbana, Illinois, United States, 61801

Indianapolis

Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana, United States, 46202

Indianapolis

Indiana Hemophilia & Thrombosis Center, Inc. (IHTC), Indianapolis, Indiana, United States, 46260

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02215

Minneapolis

Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, United States, 55404

New Hyde Park

Cohen Children's Medical Center/Northwell Health, New Hyde Park, New York, United States, 11040

Cincinnati

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States, 45229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

6 Months to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Children's Hospital Medical Center, Cincinnati,

Patrick Niss, MD, PRINCIPAL_INVESTIGATOR, Lifespan

Study Record Dates

2023-12-31