Sickle Cell Disease Clinical Trial
Official title:
Long Term Effects of Hydroxyurea Therapy in Children With Sickle Cell Disease
NCT number | NCT00305175 |
Other study ID # | HUSTLE |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 3, 2006 |
Est. completion date | April 23, 2015 |
Verified date | July 2020 |
Source | St. Jude Children's Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 260 |
Est. completion date | April 23, 2015 |
Est. primary completion date | April 23, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 30 Years |
Eligibility |
Inclusion Criteria: - Patients from birth up to age 30 years - Diagnosis of sickle cell disease - Patients who are receiving hydroxyurea therapy or plan to begin hydroxyurea therapy |
Country | Name | City | State |
---|---|---|---|
United States | St. Jude Children's Research Hospital | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
St. Jude Children's Research Hospital | Children's Hospital Medical Center, Cincinnati |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | DNA damage from hydroxyurea therapy-variable-diversity-joining (VDJ) recombination events defined as the number of events per microgram of genomic DNA; | Every 3 years | ||
Primary | DNA damage from hydroxyurea therapy-percentage of HJB in immature (CD71+) erythrocytes | Every 3 years | ||
Secondary | Brain function as measured by MRI/MRA and TCD | optional test | Every 3 years | |
Secondary | Splenic function as measured by Spleen Scan | optional test | Every 3 years | |
Secondary | Kidney function as measured by BUN/creatinine and Urinalysis, glomerular filtration rate (GFR) | optional test | Every 3 years | |
Secondary | Lung function as measured by forced vital capacity (FVC) (%), forced vital volume in 1 second (FVC1) (%), and tricuspid regurgitation (TR) jet on Echocardiogram (ECHO) | collected if performed for clinical purposes | Every 3 years | |
Secondary | Growth as measured by height and weight | Every visit |
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