Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305175
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2006-03-17
Brief Title:
Long Term Effects of Hydroxyurea Therapy in Children With Sickle Cell Disease
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
Long Term Effects of Hydroxyurea Therapy in Children With Sickle Cell Disease
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this prospective observational study are 1 to describe the long-term cellular molecular and clinical effects of hydroxyurea therapy in sickle cell disease and 2 to perform hydroxyurea pharmacokinetics studies
This study will follow sickle cell patients being treated with hydroxyurea for a long period of time to evaluate the long-term cellular and molecular effects of the drug on the patients body This study will consist of two patient groups One group will be made up of patients who have received hydroxyurea therapy before entering the study The second group will be made up of patients who have not received hydroxyurea before study entry
This study will follow sickle cell patients being treated with hydroxyurea for a long period of time to evaluate the long-term cellular and molecular effects of the drug on the patients body This study will consist of two patient groups One group will be made up of patients who have received hydroxyurea therapy before entering the study The second group will be made up of patients who have not received hydroxyurea before study entry
Detailed Description:
Many years of study have documented the severe effects of sickle cell disease Some of these effects include hemolysis the break down of red blood cells blockages in the blood vessels and damage to the organs systems of the body Hydroxyurea which is given by mouth is used to effectively prevent blockages in the blood vessels of patients with sickle cell disease The hydroxyurea dosage varies and the responses of the body to this drug are not well understood
This study will follow sickle cell patients being treated with hydroxyurea for a long period of time to evaluate the long-term cellular and molecular effects of the drug on the patients body This study will consist of two patient groups One group will be made up of patients who have received hydroxyurea therapy before entering the study Old Cohort The second group will be made up of patients who have not received hydroxyurea before study entry New Cohort
This is not a therapeutic drug trial Subjects for this study will receive hydroxyurea therapy for accepted clinical indications and will be treated per best clinical management using treatment algorithms established at St Jude Childrens Research Hospital and other pediatric sickle cell programs across the United States Hydroxyurea therapy data such as dosing and duration of therapy will not be dictated by this study but will be collected to correlate with long-term outcomes Hydroxyurea dose escalation to a stable MTD will occur according to published guidelines
This study will follow sickle cell patients being treated with hydroxyurea for a long period of time to evaluate the long-term cellular and molecular effects of the drug on the patients body This study will consist of two patient groups One group will be made up of patients who have received hydroxyurea therapy before entering the study Old Cohort The second group will be made up of patients who have not received hydroxyurea before study entry New Cohort
This is not a therapeutic drug trial Subjects for this study will receive hydroxyurea therapy for accepted clinical indications and will be treated per best clinical management using treatment algorithms established at St Jude Childrens Research Hospital and other pediatric sickle cell programs across the United States Hydroxyurea therapy data such as dosing and duration of therapy will not be dictated by this study but will be collected to correlate with long-term outcomes Hydroxyurea dose escalation to a stable MTD will occur according to published guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None