Status:
COMPLETED
Assessment of Algorithm-Based Hydroxyurea Dosing on Fetal Hemoglobin Response, Acute Complications, and Organ Function in People With Sickle Cell Disease
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
15-99 years
Phase:
PHASE1
PHASE2
Brief Summary
Background: \- Sickle cell disease (SCD) is a blood disease. The drug hydroxyurea (HU) is approved to prevent pain crises in people with SCD. Researchers want to see how higher doses of HU affect the...
Detailed Description
Sickle cell disease (SCD) is associated with significant morbidity and early mortality. Despite the discovery of the disease more than 100 years ago, only one drug, hydroxyurea (HU), has been FDA-appr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age greater than or equal to 15 years
- Homozygous sickle cell disease (HbSS)
- Patients with recent transfusion must have HbA \<15% prior to enrollment
- ANC greater than or equal to 2,000/microL, platelets greater than or equal to150,000/microL, Hb \> 5.4g/dL, and ARC greater than or equal to100,000/microL (unless the Hb is \> 8g/dL) at baseline
- Patients on angiotensin-converting enzyme inhibitors and angiotensin receptor blockers should be on a stable dose for 2 weeks prior to initiating or adjusting HU
- EXCLUSION CRITERIA:
- Pregnant or lactating women or patients planning to get pregnant during the study period
- Patients unwilling to use two forms of contraception throughout the period of HU administration
- Patients receiving chronic transfusion therapy
- Patients receiving a HU dose of greater than or equal to 20 mg/kg/day
- Patients with history of allergy or intolerance to HU judged by the investigator to be prohibitive against restarting HU
- 6 Patients with end stage renal disease defined as GFR \<10mL/min/1.73m(2)
- 7\. Patients being treated with antiretroviral agents (such as didanosine and stavudine) because of a higher risk for potentially fatal pancreatitis, hepatic failure, hepatitis, and severe peripheral neuropathy when co-administered with hydroxyurea.
- 8\. Participation on any other chronic investigative treatment studies
- 9\. Unable to understand the investigational nature of the study or give informed consent.
Exclusion
Key Trial Info
Start Date :
August 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02225132
Start Date
August 23 2014
End Date
May 24 2018
Last Update
August 6 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892