Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350844
Status:
TERMINATED
Last Update Posted:
2019-08-06
First Post:
2006-07-10
Brief Title:
Hydroxyurea for Children and Young Adults With Sickle Cell Disease and Pulmonary Hypertension
Sponsor:
Ann Robert H Lurie Childrens Hospital of Chicago
Organization:
Ann Robert H Lurie Childrens Hospital of Chicago
Study Overview
Official Title:
A Pilot Study of Hydroxyurea for the Treatment of Pulmonary Hypertension in Children and Young Adults With Sickle Cell Disease
Status:
TERMINATED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low subject accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sickle cell disease
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 sickle cell disease SCD However both the prevalence and optimal treatment of pulmonary hypertension in children and young adults with SCD are unknown
We hypothesize that short term therapy with hydroxyurea will decrease TRJV in children and young adults with pulmonary hypertension found on screening Patients eligible for treatment will have had evidence of pulmonary hypertension on at least 2 screening echocardiograms Baseline laboratory tests will be obtained and other causes of secondary pulmonary hypertension will be excluded prior to initiation of treatment Patients will be treated with hydroxyurea according to a standard dose escalation schedule for a total of 12 months A clinic visit will be required every 2 months and standard screening for toxicity will be performed monthly There will be an interim analysis of the primary outcome at 6 months following therapy
We hypothesize that short term therapy with hydroxyurea will decrease TRJV in children and young adults with pulmonary hypertension found on screening Patients eligible for treatment will have had evidence of pulmonary hypertension on at least 2 screening echocardiograms Baseline laboratory tests will be obtained and other causes of secondary pulmonary hypertension will be excluded prior to initiation of treatment Patients will be treated with hydroxyurea according to a standard dose escalation schedule for a total of 12 months A clinic visit will be required every 2 months and standard screening for toxicity will be performed monthly There will be an interim analysis of the primary outcome at 6 months following therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None