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Hydroxyurea for Sickle Cell Anemia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Cincinnati Children's Hospital Medical Center, Cincinnati, OHSickle Cell Anemia+1 MoreHydroxyurea - Drug
Eligibility
6 - 21
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Sickle Cell Anemia
  • Sickle Cell Disease

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
Imatinib Mesylate
1
FTX-6058 oral capsule(s)
1
PF-07209326

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 6 months after starting daily hydroxyurea therapy

Month 6
Gene Expression Patterns of Study Participants
Month 6
Fetal Hemoglobin (HbF) Response Following Six Months of Hydroxyurea Therapy
Month 12
F Cells

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Imatinib Mesylate
1
FTX-6058 oral capsule(s)
1
PF-07209326

Side Effects for

Anagrelide
25%Headache
24%Palpitations
12%Hypertension
8%Arthralgia
8%Diarrhoea
7%Vertigo
7%Asthenia
5%Epistaxis
5%Chest pain
5%Urinary tract infection
5%Upper respiratory tract infection
5%Anaemia
4%Ischaemic stroke
3%Nasopharyngitis
3%Pharyngitis
1%Sudden death
1%Laryngitis
1%Hyperglycaemia
1%Type 2 diabetes mellitus
1%Bladder cancer
1%Ovarian cyst
1%Respiratory distress
1%Vasculitis cerebral
1%Upper gastrointestinal haemorrhage
1%Adenoid cystic carcinoma
1%Sepsis
1%Iron deficiency anaemia
1%Angina unstable
1%Left ventricular failure
1%Crohn's disease
1%Tachycardia
1%Ear infection
1%Traumatic haematoma
1%Hypertensive crisis
1%Neurological decompensation
1%Aphasia
1%Pulmonary embolism
1%Cerebral infarction
1%Peripheral artery thrombosis
1%Leukopenia
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT00202644) in the Anagrelide ARM group. Side effects include: Headache with 25%, Palpitations with 24%, Hypertension with 12%, Arthralgia with 8%, Diarrhoea with 8%.

Trial Design

2 Treatment Groups

Standard Arm
1 of 2
Alternative Arm
1 of 2

Active Control

Experimental Treatment

116 Total Participants · 2 Treatment Groups

Primary Treatment: Hydroxyurea · No Placebo Group · Phase 3

Alternative Arm
Drug
Experimental Group · 1 Intervention: Hydroxyurea · Intervention Types: Drug
Standard Arm
Drug
ActiveComparator Group · 1 Intervention: Hydroxyurea · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxyurea
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months after starting daily hydroxyurea therapy

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
763 Previous Clinical Trials
5,421,723 Total Patients Enrolled
11 Trials studying Sickle Cell Anemia
1,587 Patients Enrolled for Sickle Cell Anemia
Doris Duke Charitable FoundationOTHER
48 Previous Clinical Trials
233,145 Total Patients Enrolled
2 Trials studying Sickle Cell Anemia
395 Patients Enrolled for Sickle Cell Anemia
Patrick Niss, MDPrincipal InvestigatorLifespan
Patrick T McGann, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati
Omar Niss, MDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Eligibility Criteria

Age 6 - 21 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You and your healthcare providers have decided to start taking hydroxyurea medication.

Who else is applying?

What state do they live in?
Ohio100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Nationwide Children's Hospital.100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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