Status:
TERMINATED
Hydroxyurea for Children and Young Adults With Sickle Cell Disease and Pulmonary Hypertension
Lead Sponsor:
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Sickle Cell Disease
Pulmonary Hypertension
Eligibility:
All Genders
10-25 years
Phase:
PHASE1
PHASE2
Brief Summary
The goal of this study is to test the hypothesis that hydroxyurea is effective for the specific treatment of secondary pulmonary hypertension found on screening in children and young adults with sickl...
Detailed Description
Increasing evidence suggests that pulmonary hypertension, defined by an elevated tricuspid regurgitant jet velocity (TRJV) on echocardiogram, is a major cause of morbidity and mortality in adults with...
Eligibility Criteria
Inclusion
- Age between 10 and 25 years old
- Sickle cell disease with hemoglobin SS, SC or S-B\^0 thalassemia confirmed on hemoglobin electrophoresis
- Tricuspid regurgitant jet velocity (TRJV) equal to or greater than 2.5 m/sec on 2 baseline Doppler echocardiograms at least 3 months apart
Exclusion
- Patients already being treated with hydroxyurea
- Patients on a chronic transfusion protocol
- Patients with evidence of hepatic (alanine aminotransferase \[ALT\] equal to or greater than 2 SD above normal) or renal dysfunction (creatinine \[Cr\] equal to or greater than 2 SD above normal)
- Patients who are pregnant
- Patients with documented causes of severe pulmonary hypertension other than from SCD
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00350844
Start Date
July 1 2006
End Date
June 1 2008
Last Update
August 6 2019
Active Locations (1)
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1
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611