- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02868138
Study of Hydroxyurea to Treat Sickle Cell Disease
Evaluation of Clinical Effectiveness, Quality of Life, and Compliance in Patients With Sickle Cell Disease Receiving Hydroxyurea
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Mersin, Kalkon, 33169
- Selma Unal
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients willing to participate in the study
- Pediatric and young adult patients
- Patients diagnosed with HbSS or HbSβ0 sickle cell disease
- Patients receiving hydroxyurea for at least a year.
Exclusion Criteria:
- Patients not meeting the inclusion criteria
- Patients not willing to participate in the study
- Patients diagnosed with other types of anemia except HbSS or HbSβ0 sickle cell disease
- Patients not receiving hydroxyurea for at least a year
- Patients having other conditions such as physical and/or mental difficulties which may affect their quality of life
- Patients having any contrindication against hydroxyurea
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Effectiveness and acceptance of hydroxyurea therapy in patients
Tidsram: Up to 12 weeks
|
Up to 12 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Demographic characteristics of patients using Demographic Data Collection Form
Tidsram: Up to 12 weeks
|
Up to 12 weeks
|
Clinical characteristics of patients using Case Report Form
Tidsram: Up to 12 weeks
|
Up to 12 weeks
|
Health status of pediatric patients using Child Health Questionnaire-Parent Form
Tidsram: Up to 12 weeks
|
Up to 12 weeks
|
Quality of life of young adult patients using Life Quality Survey Short Form-36
Tidsram: Up to 12 weeks
|
Up to 12 weeks
|
Effectiveness of hydroxyurea therapy in patients using Case Report Form
Tidsram: Up to 12 weeks
|
Up to 12 weeks
|
Acceptance of hydroxyurea therapy in patients using Hydroxyurea Satisfaction Survey
Tidsram: Up to 12 weeks
|
Up to 12 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: BAHAR TUNCTAN, Ph.D., MERSIN UNIVERSITY FACULTY OF PHARMACY DEPARTMENT OF PHARMACOLOGY
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MEUKAEK-2016/27 - 16-AKD-19
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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