- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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-
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Mersin, Tyrkia, 33169
- Selma Unal
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Effectiveness and acceptance of hydroxyurea therapy in patients
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Demographic characteristics of patients using Demographic Data Collection Form
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
Clinical characteristics of patients using Case Report Form
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
Health status of pediatric patients using Child Health Questionnaire-Parent Form
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
Quality of life of young adult patients using Life Quality Survey Short Form-36
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
Effectiveness of hydroxyurea therapy in patients using Case Report Form
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
Acceptance of hydroxyurea therapy in patients using Hydroxyurea Satisfaction Survey
Tidsramme: Up to 12 weeks
|
Up to 12 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: BAHAR TUNCTAN, Ph.D., MERSIN UNIVERSITY FACULTY OF PHARMACY DEPARTMENT OF PHARMACOLOGY
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MEUKAEK-2016/27 - 16-AKD-19
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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