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Anti-metabolites

Hydroxyurea for Sickle Cell Anemia (HOPS Trial)

Phase 3
Recruiting
Led By Patrick T McGann, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after starting daily hydroxyurea therapy
Awards & highlights

HOPS Trial Summary

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.

Who is the study for?
This trial is for children and young adults aged 6 months to 21 years with severe forms of sickle cell anemia who have decided, along with their healthcare providers, to start treatment with hydroxyurea. It's not open to those currently on chronic blood transfusions or erythrocytapheresis, pregnant or lactating individuals, patients treated with hydroxyurea in the past 3 months, or those taking other investigational drugs for sickle cell.Check my eligibility
What is being tested?
The HOPS trial is testing a new way of dosing hydroxyurea based on individual drug processing (pharmacokinetics) against the usual method based on body weight in kids with sickle cell anemia. The goal is to see if this new strategy leads to better levels of fetal hemoglobin compared to standard dosing.See study design
What are the potential side effects?
Hydroxyurea can cause side effects like bone marrow suppression which may lead to low blood counts, digestive issues such as nausea and vomiting, skin changes including rashes and ulcers, and increased risk of infections due to its impact on the immune system.

HOPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after initial hydroxyurea therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after initial hydroxyurea therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fetal Hemoglobin (HbF) Response Following Six Months of Hydroxyurea Therapy
Secondary outcome measures
F Cells
Gene Expression Patterns of Study Participants

Side effects data

From 2015 Phase 4 trial • 150 Patients • NCT00202644
25%
Headache
24%
Palpitations
12%
Hypertension
8%
Diarrhoea
8%
Arthralgia
7%
Vertigo
7%
Asthenia
5%
Epistaxis
5%
Anaemia
5%
Chest pain
5%
Upper respiratory tract infection
5%
Urinary tract infection
4%
Ischaemic stroke
3%
Nasopharyngitis
3%
Pharyngitis
1%
Cerebral infarction
1%
Neurological decompensation
1%
Vasculitis cerebral
1%
Aphasia
1%
Type 2 diabetes mellitus
1%
Bladder cancer
1%
Left ventricular failure
1%
Respiratory distress
1%
Sepsis
1%
Ovarian cyst
1%
Adenoid cystic carcinoma
1%
Pulmonary embolism
1%
Crohn's disease
1%
Tachycardia
1%
Laryngitis
1%
Upper gastrointestinal haemorrhage
1%
Sudden death
1%
Ear infection
1%
Leukopenia
1%
Hypertensive crisis
1%
Peripheral artery thrombosis
1%
Iron deficiency anaemia
1%
Angina unstable
1%
Traumatic haematoma
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anagrelide
Hydroxyurea

HOPS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Alternative ArmExperimental Treatment1 Intervention
Participants randomized to the alternative arm will receive a pharmacokinetic guided starting dose of hydroxyurea based on PK labs drawn at a baseline visit to target an area under the curve (AUC) of 115 mg*h/L in an attempt to approximate maximum tolerated dose (MTD). This dose will not exceed the maximum tolerated dose of 35 mg/kg/day.
Group II: Standard ArmActive Control1 Intervention
Participants randomized to the standard arm will receive a starting dose of hydroxyurea of 20 mg/kg/day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxyurea
2006
Completed Phase 4
~3620

Find a Location

Who is running the clinical trial?

Doris Duke Charitable FoundationOTHER
61 Previous Clinical Trials
260,009 Total Patients Enrolled
4 Trials studying Sickle Cell Anemia
472 Patients Enrolled for Sickle Cell Anemia
Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,480 Total Patients Enrolled
11 Trials studying Sickle Cell Anemia
1,587 Patients Enrolled for Sickle Cell Anemia
Patrick T McGann, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Media Library

Hydroxyurea (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03789591 — Phase 3
Sickle Cell Anemia Research Study Groups: Standard Arm, Alternative Arm
Sickle Cell Anemia Clinical Trial 2023: Hydroxyurea Highlights & Side Effects. Trial Name: NCT03789591 — Phase 3
Hydroxyurea (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03789591 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Nationwide Children's Hospital.
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
TrialsJournal
Hydroxyurea Optimization Through Precision Study (HOPS): Study Protocol for a Randomized, Multicenter Trial in Children with Sickle Cell Anemia
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.
clinicaltrials.govStudy
Hydroxyurea Optimization Through Precision Study
2019. "Hydroxyurea Optimization Through Precision Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03789591.
~19 spots leftby Apr 2025
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