This trial will compare a new, individualized dosing strategy of hydroxyurea to standard weight-based dosing for children with SCA, in order to see if the former leads to a better response in terms of fetal hemoglobin levels.
- Sickle Cell Anemia
- Sickle Cell Disease
1 Primary · 2 Secondary · Reporting Duration: 6 months after starting daily hydroxyurea therapy
Side Effects for
2 Treatment Groups
1 of 2
1 of 2
116 Total Participants · 2 Treatment Groups
Primary Treatment: Hydroxyurea · No Placebo Group · Phase 3
Who is running the clinical trial?
Age 6 - 21 · All Participants · 3 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Who else is applying?
What state do they live in?
How old are they?
|18 - 65||100.0%|
What site did they apply to?
|Nationwide Children's Hospital.||100.0%|
What portion of applicants met pre-screening criteria?
|Did not meet criteria||100.0%|
- Meier, Emily R., Susan E. Creary, Matthew M. Heeney, Min Dong, Abena O. Appiah-Kubi, Stephen C. Nelson, Omar Niss, et al.. 2020. “Hydroxyurea Optimization Through Precision Study (HOPS): Study Protocol for a Randomized, Multicenter Trial in Children with Sickle Cell Anemia”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-020-04912-z.
- 2019. "Hydroxyurea Optimization Through Precision Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03789591.
Frequently Asked Questions
Are there other scientific papers which mention Hydroxyurea?
"Hydroxyurea was first studied in 2009 at Ospedale Civile di Rovigo. As of now, there have been 57 completed studies with 30 more currently underway. A large number of these trials are based in Milwaukee, Wisconsin." - Anonymous Online Contributor
What are some common conditions that Hydroxyurea is used to help manage?
"Hydroxyurea is commonly used to treat patients with malignant melanoma of the skin. Additionally, it can be employed to help manage hypereosinophilic syndrome (HES), neoplasm metastasis, and myeloid leukemia." - Anonymous Online Contributor
At how many different medical facilities can patients enroll in this clinical trial?
"There are 13 sites currently enrolling patients for this clinical trial. The locations include Indianapolis, Cleveland and Milwaukee as well as other cities. To reduce travel burden, please choose the site nearest you." - Anonymous Online Contributor
How many participants are being recruited for this research project?
"That is correct, the online information hosted on clinicaltrials.gov affirms that this study is looking for participants. The listing was first put up on January 17th, 2019 and was most recently updated on December 7th, 2021. In total, the research team is looking to enroll 116 individuals from 13 different locations." - Anonymous Online Contributor
Are participants in this trial required to be 18 years or older?
"For this particular study, only patients aged 6 months to 21 years old can apply. In total, there are 223 clinical trials for minors and 263 for senior citizens." - Anonymous Online Contributor
Are they currently enrolling new participants for this clinical trial?
"Based on the information available on clinicaltrials.gov, this clinical trial is still open to recruiting patients. The study was first posted on 1/17/2019 and was last updated on 12/7/2021." - Anonymous Online Contributor
What hydroxyurea side effects have been most commonly observed in patients?
"Hydroxyurea's safety has been well documented in Phase 3 trials, and so it receives a score of 3 from Power." - Anonymous Online Contributor
Does my individual health history qualify me to participate in this research project?
"This particular study is looking for 116 participants that suffer from anemia and meet the age criteria of being between 6 months and 21 years old. In addition, it is essential that potential patients also fit the following bill: A diagnosis of sickle cell anemia (HbSS, HbSD, HbS/β0-thalassemia, or a similar SCA genotype), Being 6 months to 21 years old at the time of enrollment into the study, A decision made by the patient, their family, and their healthcare providers to start hydroxyurea therapy." - Anonymous Online Contributor