COMPLETED

Hydroxyurea Optimization Through Precision Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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.

Quick Facts

Study Start:2019-01-17
Study Completion:2025-03-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03789591

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.

Ages Eligible for Study:6 Months to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of sickle cell anemia (HbSS, HbSD, HbS/β0-thalassemia, or similarly severe SCA genotype)
  2. * Age 6 months to 21 years at the time of enrollment
  3. * Clinical decision by patient, family, and healthcare providers to initiate hydroxyurea therapy
  1. * Current treatment with chronic, monthly blood transfusions or erythrocytapheresis
  2. * Treatment with hydroxyurea within the past 3 months
  3. * Hemoglobin SC disease, HbS/β+-thalassemia
  4. * Current treatment with other investigational sickle cell medications
  5. * Current known pregnancy or lactation

Contacts and Locations

Principal Investigator

Patrick Niss, MD
PRINCIPAL_INVESTIGATOR
Lifespan

Study Locations (Sites)

Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30342
United States
Children's Hospital of Illinois
Peoria, Illinois, 61637
United States
Carle Foundation Hospital
Urbana, Illinois, 61801
United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
United States
Indiana Hemophilia & Thrombosis Center, Inc. (IHTC)
Indianapolis, Indiana, 46260
United States
Boston Children's Hospital
Boston, Massachusetts, 02215
United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
United States
Cohen Children's Medical Center/Northwell Health
New Hyde Park, New York, 11040
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Rainbow Babies / University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Nationwide Children's Hospital.
Columbus, Ohio, 43205
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Lifespan

  • Patrick Niss, MD, PRINCIPAL_INVESTIGATOR, Lifespan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-17
Study Completion Date2025-03-19

Study Record Updates

Study Start Date2019-01-17
Study Completion Date2025-03-19

Terms related to this study

Keywords Provided by Researchers

  • Hydroxyurea
  • HbSS
  • HbSD
  • TREAT

Additional Relevant MeSH Terms

  • Sickle Cell Disease
  • Sickle Cell Anemia