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NCT03789591CompletedPhase 3

Hydroxyurea Optimization Through Precision Study

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.

Source: ClinicalTrials.gov · Last updated 18 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
104 (actual)
First submitted
27 Nov 2018
Start date
Jan 2019
Primary completion date
Mar 2025
Lead sponsor
Lifespan
NCT number
NCT03789591

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 104
  • From Jan 2019 to the primary completion date, Mar 2025
  • 13 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current treatment with chronic, monthly blood transfusions or erythrocytapheresis
  • Treatment with hydroxyurea within the past 3 months
  • Current treatment with other investigational sickle cell medications

Lab values

  • Hemoglobin SC disease, HbS/β+-thalassemia

Other

  • Current known pregnancy or lactation

Who the study is looking for

  • 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

Age in the registry: 6 months to 21 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Healthcare of Atlanta
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Boston Children's Hospital
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BostonUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Rainbow Babies / University Hospitals Cleveland Medical Center
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Nationwide Children's Hospital
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
Riley Hospital for Children at Indiana University Health
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Indiana Hemophilia & Thrombosis Center, Inc. (IHTC)
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status
Children's Hospital of Wisconsin
Coordinator of this site? Confirm its status
MilwaukeeUnited StatesUnknown status
Children's Hospitals and Clinics of Minnesota
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MinneapolisUnited StatesUnknown status
Cohen Children's Medical Center/Northwell Health
Coordinator of this site? Confirm its status
New Hyde ParkUnited StatesUnknown status
Children's Hospital of Illinois
Coordinator of this site? Confirm its status
PeoriaUnited StatesUnknown status
Phoenix Children s Hospital
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PhoenixUnited StatesUnknown status
Carle Foundation Hospital
Coordinator of this site? Confirm its status
UrbanaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.