Study of Hydroxyurea to Treat Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT02868138|
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
|Condition or disease|
|Sickle Cell Disease|
In this study, 34 pediatric (HbSS: n= 5; HbSβ0: n= 29) and 16 (HbSS: n=5; HbSβ0: n= 11) young adult adult patients with sickle cell disease receiving hydroxyurea for at least a year were participated. Upon receipt of Informed Consent Form, Case Report Form, Demographic Data Collection Form, Child Health Questionnaire-Parent Form, Life Quality Survey Short Form-36, and Hydroxyurea Therapy Satisfaction Survey were used to obtain data for effectiveness of hydroxyurea therapy and parameters that may affect compliance to treatment and life quality of the participants.
Regarding the normal ranges, ferritin, hemoglobin A, A2, F, and S, platelet, mean corpuscular volume, erythrocyte distribution width, basophil percentage, monocyte, monocyte percentage, total bilirubin, direct bilirubin, and C-reactive protein values were higher while hemoglobin, hematocrit, and erythrocyte values were lower in these patients. Our findings regarding quality of life and satisfaction with hydroxyurea therapy indicated that the patients with sickle cell disease had lower scores.
Demographic, clinical, and therapeutic variables as well as comorbid diseases and concomitant drug use when considered together, these findings suggest that the health quality and compliance of the pediatric and young adult patients to therapy might be low due to not sufficiently effective hydroxyurea therapy in addition to comorbidities, concomitant drug use, and side effects.
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Evaluation of Clinical Effectiveness, Quality of Life, and Compliance in Patients With Sickle Cell Disease Receiving Hydroxyurea|
|Study Start Date :||May 2016|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||July 2016|
- Effectiveness and acceptance of hydroxyurea therapy in patients [ Time Frame: Up to 12 weeks ]
- Demographic characteristics of patients using Demographic Data Collection Form [ Time Frame: Up to 12 weeks ]
- Clinical characteristics of patients using Case Report Form [ Time Frame: Up to 12 weeks ]
- Health status of pediatric patients using Child Health Questionnaire-Parent Form [ Time Frame: Up to 12 weeks ]
- Quality of life of young adult patients using Life Quality Survey Short Form-36 [ Time Frame: Up to 12 weeks ]
- Effectiveness of hydroxyurea therapy in patients using Case Report Form [ Time Frame: Up to 12 weeks ]
- Acceptance of hydroxyurea therapy in patients using Hydroxyurea Satisfaction Survey [ Time Frame: Up to 12 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02868138
|Mersin, Turkey, 33169|
|Study Chair:||BAHAR TUNCTAN, Ph.D.||MERSIN UNIVERSITY FACULTY OF PHARMACY DEPARTMENT OF PHARMACOLOGY|